Medical Devices · iii. Are establishments manufacturing medical devices, or components of medical...

www.lexmundi.com

Medical Devices

A Global Practice Guide prepared by the Lex Mundi Life Sciences Practice Group

Global Practice Guide

Lex Mundi is the world’s leading network of independent law firms with in-depth experience in 100+ countries. Through close collaboration, our member firms are able to offer their clients preferred access to more than 21,000 lawyers worldwide – a global resource of unmatched breadth and depth.

Lex Mundi – the law firms that know your markets.

This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete series at: www.lexmundi.com/GlobalPracticeGuides.

http://www.lexmundi.com/lexmundi/Global_Practice_Guides.asphttp://www.lexmundi.com/lexmundi/Global_Practice_Guides.asp

www.lexmundi.com Page 1 © 2012 Lex Mundi

About This Guide Medical devices are part of a rapidly growing business that is driven by new technology achievements and developments, as well as the desire for increased life expectancy and better healthcare. Emerging technologies require new legal regulation so that all combined and borderline products are properly covered. These products are becoming increasingly more standardized, which facilitates their worldwide distribution and use. The purpose of this guide is to gain a general overview of the legal regulations that guide the medical device business throughout the world and to provide Lex Mundi members access to information to better serve their clients. Table of Contents Austria.................................................................................................................................................... 2 Barbados................................................................................................................................................ 8 Brazil .................................................................................................................................................... 13 Cyprus.................................................................................................................................................. 20 Czech Republic .................................................................................................................................... 25 Estonia ................................................................................................................................................. 32 Finland ................................................................................................................................................. 39 Ireland .................................................................................................................................................. 46 Latvia.................................................................................................................................................... 63 Lithuania .............................................................................................................................................. 71 Poland .................................................................................................................................................. 80 Romania ............................................................................................................................................... 88 South Africa ......................................................................................................................................... 96 Switzerland ........................................................................................................................................ 107 Taiwan ................................................................................................................................................ 116 Thailand ............................................................................................................................................. 123 Ukraine ............................................................................................................................................... 129 USA, Arkansas ................................................................................................................................... 135


Medical Devices Austria Prepared by Lex Mundi member firm CHSH Cerha Hempel Spiegelfeld Hlawati 1. Definition of medical devices

What is the definition of a medical device in your jurisdiction? Pursuant to Section 1 (1) of the Austrian Medical Devices Act (Medizinproduktegesetz, hereinafter: MPG), a medical device is any tool, instrument, machine or substance (including software which is required for the functioning of a medical device) for which the producers intend use on human beings for

a. detection, prevention, monitoring, treatment or relief of illnesses, b. detection, monitoring, treatment, relief of injuries and handicaps c. examination, modification or replacement of anatomic buildup or physiological events; d. birth control

and which have a main effect in or on the human body that cannot be reached by pharmacological or immunological nor metabolic means, even though their functioning can be supported by such means.

2. Combination products

i. Which legal regime (on medicinal product or on medical devices) applies to combination products incorporating both medicinal products (drugs/biologics) and medical devices?

Generally, under Section 5 (2) MPG the legal regime on medicinal products applies, but when authorities grant permits, the provisions of the MPG have to be respected as well.

ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction?

See answer to question (i).

iii. If the answer to (i) is negative, what is the scope of application of the legal regimes: evaluating both the drug and device components of the combination product? -

iv. What are the general conditions for review, approval and marketing the combination

product? Depending on the nature of the product, a clinical trial has to be undertaken in order to obtain a distribution permit. Marketing restrictions under the MPG apply.


3. Borderline products

Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device? i. Are there any legal and binding criteria for determination whether the product is a

medical device or medicinal product? Yes, partly: If a medical device (with the exception of in-vitro-diagnostics) contains a product which – taken apart – would qualify as a medical device, the device qualifies as a medical device (Section 5 (3) MPG).

ii. If the answer to (i) is positive, what are the main principles for differentiation?

See answer to question (i). iii. Are there any significant court or administrative judgments demonstrating the rules of

product differentiation? Until now, the Austrian Supreme Court had to deal only in few cases with product differentiation and mainly referred to the wording of the law.

iv. How is software that may have some related-medical applications regulated in your jurisdiction? Under Section 1 (1) MPG, also software required for purposes of a medical device qualifies as a medical device. Rules on medical devices apply.

4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is an animal or human based tissue or a medical device? There are no criteria. The MPG simply states that it does not apply to products based on human or animal tissues, with the exception of deadened animal tissues used for the production of medical devices. i. How are products composed of cells or animal/human tissue regulated in your

jurisdiction? To such products, the Tissue Safety Law (Gewebesicherheitsgesetz) applies.

ii. Are there any legal and binding criteria for determination whether the product is a

medical device or cellular/tissue based product? No.

iii. If the answer to (ii) is positive, what are the main principles for differentiation?

iv. Are there any significant court or administrative judgments demonstrating the rules of

product differentiation? no.


5. Admission to trade of medical devices

What are the requirements for admission (import) of medical devices into trade? As a general rule, medical devices have to be CE marked. Further, they have to be safe as described under several ordinances. i. Is clinical assessment required for admitting (importing) medical devices into trade?

Not necessarily: Only for specific devices such testing may be prescribed by ordinance. ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for

clinical assessment? If such testing is prescribed, there is no alternative.

iii. Is certification by an external certifying body required for compliance assessment of medical devices, or is a manufacturer’s declaration of conformity sufficient? CE marking is required, which can only be obtained from independent testing institutions.

iv. Is administrative pre-clearance or pre-approval of medical devices required for admission of medical devices into trade, or is post-launch notification sufficient?

CE marking (generally) is sufficient. If other criteria apply (clinical testing), they have to be fulfilled beforehand.

6. Processing of personal data (privacy) What are the rules of processing of personal data in a number of activities performed by manufacturer/s distributors/ healthcare units with the use of medical devices.

i. Are there any specific rules protecting the privacy of personal data of consumers

purchasing medical devices, by manufacturer/distributors?

General data protection rules apply. Moreover, Section 11 (4) MPG stipulates that privacy and human dignity have to be respected and that secrecy of personal data has to be assured. Under secs 110 et seq MPG, staff handling medical devices is obliged to respect privacy rights of the patients concerned. The same provisions contain an authorization for processing of data collected in the course of handling medical devices.

ii. Are there any specific rules of processing of personal data sourced by means of medical devices containing software, by healthcare units?

Besides the ones stated in answer (i), no.

iii. Are there any specific rules of processing of personal data by manufacturers/distributors

in case of collecting reports on medical incidents from customers? Besides the ones stated in answer (i), no.

iv. What is the standard for reporting adverse events, and is reporting of events in foreign countries required, and using what standards?

Section 70 MPG stipulates reporting duties of medical staff concerning all major incidents relating to medical devices. Reportings have to be filed with the Federal Ministry of Health. There are no specific reporting obligations concerning incidents in foreign countries. However, also the first


importer of a medical device into the EU has to be notified of any incident (Section 70 (4) MPG). Since reporting duties bind the medical professions, reporting might also take place in case they learn of an incident that has occurred abroad.

7. Reimbursement What is the optimal model of reimbursement of medical devices? Generally, medical devices are reimbursed if listed on a list established by the Austrian social security system and prescribed by a medical practitioner. If so, depending on the social insurance of the patient concerned, patients either receive the device without having to pay anything (or only a participation), or they have to pay for it and are reimbursed afterwards. i. What are the rules of granting reimbursement of medical devices in your jurisdiction?

Medical devices for which reimbursement can be obtained have to be listed by the social security system.

8. Distribution Is distribution and promotion of medical devices subject to legal regulation?

i. Are there any specific regulations determining mode of business activity of medical

devices distributors? Under the Austrian Trade Act (Gewerbeordnung), distributors have to apply for a trade license for trade in medical devices and have to prove that they have certain knowledge in the relevant fields either by passing an exam or by demonstrating by other means (eg studies completed) that they avail over the required qualifications. See above.

ii. Is administrative permit for medical devices distribution required?


iii. Are there any specific limitations in distributing medical devices in your jurisdiction?


iv. Are obligations of distributors of medical devices specifically legally regulated?


v. What specific rules exist for advertising and promoting medical devices?

Promotion for medical devices that is misleading is forbidden (Section 102 (1) MPG). Moreover, promotion directed to consumers is forbidden for medical devices for which a prescription by a medical practitioner is required and which are designed to be used by medical staff only. Promotion directed to consumers has to be clearly marked as promotion and must contain basic indications as to producers, use and other specifications. Finally, promotion must not leave the impression that the product concerned is better suited than another product or that treatment by a medical practitioner is not necessary.


9. Manufacturing

How are manufacturing practices regulated?

i. Are there any specific standards or regulations determining the quality of manufacturing practices?

No, since the Austrian law rather looks at the device when finished (which then has to be safe). However, in order to get CE marking, adherence to certain production criteria such as standards might be required (depending on the product).

ii. If the answer to (i) is positive, how are these good manufacturing practices or quality system regulations reviewed and enforced?

iii. Are establishments manufacturing medical devices, or components of medical devices,

required to be registered with a government regulator? Any responsible person for the first importation of a medical device into the EU as well as an assembler of medical devices is obliged to register with the Federal Ministry of Health.

iv. Are these establishments inspected regularly by government regulators or authorized bodies, and what is the mode of such inspections?

The law confers general surveillance powers upon the authorities; it is up to their discretion whether they inspect establishments frequently. Authorities may ask for reports and other documentation as well as product samples, but may also make on site visits. Frequency of such visits and other surveillance measures may vary according to incidents reported and potential dangers resulting from the product in question.

10. Regulatory Guidance How are the requirements communicated to medical device manufacturers?

i. In what form do the laws and regulations appear that are applicable to medical device

manufacturers? All laws applicable in Austria can be found in the official database on the internet http://ris.bka.gv.at.

http://ris.bka.gv.at/�


ii. Are informal guidance or the opinions of regulators available to device makers, and in

what form? The Federal Ministry of Health (http://www.bmg.gv.at/home/Schwerpunkte/Krankheiten/Newsletter_Public_Health/Archiv_2010/Oesterreichische_Rechtsvorschriften_ueber_Medizinprodukte) as well as the Austrian Economic Chamber (wko.at) publish information on their homepage. Most information on the website of the Austrian Economic Chamber is only available to its members.

Contact Information Thomas Zivny [email protected] Stefan Huber [email protected]

CHSH Cerha Hempel Spiegelfeld Hlawati Parkring 2 A-1010 Vienna, Austria Tel 43.1.514.35.0 Fax 43.1.514.35.35 www.chsh.com

This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides

http://www.bmg.gv.at/home/Schwerpunkte/Krankheiten/Newsletter_Public_Health/Archiv_2010/Oesterreichische_Rechtsvorschriften_ueber_Medizinprodukte�http://www.bmg.gv.at/home/Schwerpunkte/Krankheiten/Newsletter_Public_Health/Archiv_2010/Oesterreichische_Rechtsvorschriften_ueber_Medizinprodukte�http://www.lexmundi.com/GlobalPracticeGuides�


Medical Devices Barbados Prepared by Lex Mundi member firm Clarke Gittens Farmer 1. Definition of medical devices

What is the definition of a medical device in your jurisdiction? There is no specific definition of “medical device” but Regulation 2 of the Health Services (Control of Drugs) Regulations, 1970 defines the word “device” as follows: “‘device’ means any instrument, apparatus or contrivance including components, parts or accessories thereof manufactured, sold or represented for the use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state or the symptoms thereof in man or animal”

2. Combination products i. Which legal regime (on medicinal product or on medical devices) applies to combination

products incorporating both medicinal products (drugs/biologics) and medical devices? Although the Health Services (Control of Drugs) Regulations, 1970, refers to drugs and devices, most of the regulations refer to drugs. Presumably, to the extent that it incorporates dugs, a combination product would be subject to the same regime as drugs. The Drug Control Advisory Committee established under the Health Services Act, Cap. 44, advises the Minister of Health on matters relating to the manufacture and production of drugs in Barbados. Such drugs must comply with standards contained in publications specified in the Second Schedule to the Regulations.

ii. Are combination products (combining drugs and medical devices) subject to separate

regulation in your jurisdiction? No.

iii. If the answer to (i) is negative, what is the scope of application of the legal regimes: evaluating both the drug and device components of the combination product? Manufacture or production of drugs requires a license and is subject to supervision, analysis and labeling requirements. There is provision for inspection, seizure and analysis of “articles” to which the Regulations relates.

iv. What are the general conditions for review, approval and marketing the combination product? Regulation 8 of the Health Services (Control of Dugs) Regulations, 1970 provides for the following: a. No person shall manufacture or produce for sale any drug unless he is licensed to do so,

the process is under the supervision of a pharmacist, each batch is subjected to analysis and assay as determined by the Chief Medical Officer, and each container is labeled as prescribed.

b. A drug manufactured or produced in Barbados may not be sold it confirms to one of the standards specified in the Second Schedule to the Regulations; it has been analysed and approved by the Chief Medical Officer.

Regulation 6 proscribes the sale and advertising of any drug or device in a manner that is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. The importation, manufacture, sale or dispensation of certain listed drugs is prohibited except with the license of the Minister of Health (Regulation 10 and Fourth Schedule)


Samples of drugs or devices may only be made to medical practitioners, dentists, veterinary surgeons or pharmacists. (Regulation 11) A drug which is legally saleable for consumption in another country may be imported to Barbados if that drug wholly complies with the law of the country in which it was manufactured or produced. The onus is on the importer to prove such compliance (Regulation 12) The Regulations provide for inspection, seizure, analysis and destruction of drugs and “articles” (Regulations 13 – 14)

3. Borderline products Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device? i. Are there any legal and binding criteria for determination whether the product is a

medical device or medicinal product? There are no legal and binding criteria for determination as to whether the product is a medical device or medicinal product.

ii. If the answer to (i) is positive, what are the main principles for differentiation? Not Applicable.

iii. Are there any significant court or administrative judgments demonstrating the rules of product differentiation?

iv. How is software that may have some related-medical applications regulated in your jurisdiction? Software of this type is not specifically regulated in Barbados. However, such software may fall within the definition of “device” and would be subject to the Regulations referred to above.

4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device? i. How are products composed of cells or animal/human tissue regulated in your

jurisdiction? Regulations 18 and 23 of the Animals (Diseases and Importation Control) Regulations, 1961 state as follows: Regulation 18

“No animal products, including hides, skins, horns, hair, wool, bones, bone meal, meat scrap and tankage, shall be imported into the Island except in accordance with the terms of a permit granted by the Senior Veterinary Officer and subject to such conditions as he may therein impose” Regulation 23 “(1) No biological product prepared from animal tissues intended for use in veterinary

medicine shall be imported into the Island except in accordance with the terms of a permit granted by the Senior Veterinary Officer.

(2) In this regulation, “biological product” includes any substance commonly known as

hormones, vaccines, sera, toxins, anti-toxins and antigens intended for use in the practice of veterinary medicine.”

ii. Are there any legal and binding criteria for determination whether the product is a medical device or cellular/tissue based product?

There are no legal or binding criteria for determination whether the product is a medical device or a cellular/tissue based product.

iii. If the answer to (ii) is positive, what are the main principles for differentiation? Not applicable.



product differentiation? We are not aware of any significant court or administrative judgments which demonstrate the rules of product differentiation in this context.

5. Admission to trade of medical devices What are the requirements for admission (import) of medical devices into trade? i. Is clinical assessment required for admitting (importing) medical devices into trade?

Yes, clinical assessment is required. Refer to 2(iv) above.

ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for clinical assessment? In order to import medical devices into Barbados, all clinical trials on the devices must have been done prior to importation and must be done to the standards of the International Organization for Standardization.

iii. Is certification by an external certifying body required for compliance assessment of medical devices, or is a manufacturer’s declaration of conformity sufficient

A drug (which definition may include a medical device involving a drug) which is legally saleable for consumption in another country may be imported to Barbados if that drug wholly complies with the law of the country in which it was manufactured or produced. The onus is on the importer to prove such compliance (Regulation 12)

iv. Is administrative pre-clearance or pre-approval of medical devices required for admission of medical devices into trade, or is post-launch notification sufficient

There are no specific regulations on this point.

6. Processing of personal data (privacy) What are the rules of processing of personal data in a number of activities performed by manufacturer/s distributors/ healthcare units with the use of medical devices. i. Are there any specific rules protecting the privacy of personal data of consumers

purchasing medical devices, by manufacturer/distributors? No, there are no specific rules to be followed by manufacturers/distributors which protect the privacy of personal data of consumers who purchase medical devices.


No, there are no specific rules of processing of personal data which has been sourced by means of medical devices containing software by healthcare units.

iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers? Not that we are aware of.

iv. What is the standard for reporting adverse events, and is reporting of events in foreign countries required, and using what standards? The standards used are those stipulated by the International Organization for Standardization.

7. Reimbursement What is the optimal model of reimbursement of medical devices? i. What are the rules of granting reimbursement of medical devices in your jurisdiction?

8. Distribution

Is distribution and promotion of medical devices subject to legal regulation? i. Are there any specific regulations determining mode of business activity of medical

devices distributors? This type of business activity is governed by the Health Services (Control of Drugs) Regulations, 1970.


ii. Is administrative permit for medical devices distribution required? If the medical device includes a drug, the importation, sale or manufacture of the device will be subject to the rules discussed at 2 above. Otherwise, no administrative permit is required.


Pursuant to Regulation 11 of the Health Services (Control of Drugs) Regulations, 1970:

“No person shall distribute or cause to be distributed any…device as a sample except to a medical practitioner, dentist, veterinary surgeon or druggist.”

However, there are no other limitations to the distribution of medical devices except as outlined above.

iv. Are obligations of distributors of medical devices specifically legally regulated? Save as provided for in the general laws governing fair trading and liability at common law in tort, the obligations of distributors of medical devices are not specifically legally regulated.

v. What specific rules exist for advertising and promoting medical devices? Regulations 4 and 6 of the Health Services (Control of Drugs) Regulations, 1970 provide the following:

“4. No person shall - (a) advertise any…device for the treatment, prevention or cure of any of the diseases mentioned in the First Schedule; or 6. No person shall…advertise any…device in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.”

9. Manufacturing How are manufacturing practices regulated? i. Are there any specific standards or regulations determining the quality of manufacturing

practices? To the extent that a medical device could include a drug, the manufacture of a device would be governed by the Health Services (Control of Drugs) Regulations, 1970, discussed at 2 above. Otherwise, there are no specific national standards or regulations which determine the quality of manufacturing practices for medical devices. Barbados conforms to the standards which are set out by the International Organization for Standardization.


Subject to the comments above, Regulation 8 of the Health Services (Control of Drugs) Regulations, 1970, gives power to the Chief Medical Officer to license, inspect, analyse, seize and destroy “articles” connected with the manufacture of drugs.

iii. Are establishments manufacturing medical devices, or components of medical devices, required to be registered with a government regulator?

If such device or component includes drugs, the manufacturer or producer requires to be licensed. See 2. above.


iv. Are these establishments inspected regularly by government regulators or authorized bodies, and what is the mode of such inspections? To the best of our information, there are presently no undertakings manufacturing medical devices or components of medical devices in Barbados.



manufacturers? The laws and regulations are publicly available for purchase at the Barbados Government Printery and on the internet.

ii. Are informal guidance or the opinions of regulators available to device makers, and in what form? Unknown

Contact Information Danielle Maycock [email protected]

Clarke Gittens Farmer Parker House Wildey Business Park Wildey Road St. Michael, BB14006 Barbados Tel 1.246.436.6287 Fax 1.246.436.9812 www.clarkes.com.bb


http://www.lexmundi.com/GlobalPracticeGuides�


Medical Devices Brazil Prepared by Lex Mundi member firm Demarest e Almeida 1. Definition of medical devices

What is the definition of a medical device in your jurisdiction?

In our jurisdiction, medical devices, health material or related products are considered the devices, materials or accessories which the use or application is connected to the defense and protection of individual or public health, personal or environmental hygiene, or with the purpose of diagnostic and analysis, the cosmetics and perfumes, and, yet, dietetic, optical, medical acoustics, dental and veterinary products.



Medicinal products, medical devices, pharmaceutical feedstock, cosmetics and related products are regulated in Brazil by the same laws, mainly Laws Nos. 5.991/73 and 6.360/76 and Decree No. 79.094/77 of the Brazilian Sanitary Surveillance Agency - ANVISA

Please be aware that ANVISA is entitled to issue legal provisions about human health issues in accordance with article 24, section XII, of the Brazilian Constitution, as well as per article 7 of Law No. 9.782/99, which enable such Agency to proceed with the surveillance and regulation of medicines and medical goods, to supervise the corresponding companies that manufacture and distribute them, to provide the registration of medical products etc.

Although the same law approaches both medicinal products and medical devices, such legislation does not establish which legal regime is applicable to the combination of products incorporating both medical products and medical devices.

ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction?

As mentioned above, in Brazil, there is not a specific regulation about combination products. Nevertheless, Federal Laws No. 5.991/73 and 6.360/76 and ANVISA's Decree No. 79.094/77 regulates both drugs and medical devices.

iii. If the answer to (i) is negative, what is the scope of application of the legal regimes: evaluating both the drug and device components of the combination product?

Not applicable.

iv. What are the general conditions for review, approval and marketing the combination product?

The general conditions for review, approval and marketing are established by ANVISA's Regulation No. 185. Basically, the product must present appropriate packaging, label and leaflet


with use instructions. Moreover, the manufacturer must prepare a detailed technical report describing the product, its purposes, contents, precautions, restrictions, form of presentation, among other specifications and mainly, a description of its effectiveness and safety.


Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device?

Law No 5.991/73 foresees the criteria for determination whether the product is a medicinal product or medical device and devices that require a pre-review by the Ministry of Health and ANVISA in Brazil.

i. Are there any legal and binding criteria for determination whether the product is a medical device or medicinal product?

Law No. 5.991/73 defines the criteria for determination whether the product is a medicinal product or medical device.


Drugs are the substances and raw material that have sanitary or medication purposes. Medicines are the pharmaceutical products, technically obtained or elaborated with prophylactic, curative, palliative or diagnostic purpose. Medical devices are defined as substances, products, devices or accessories which the use or application is connected to the defense and protection of individual or public health, personal or environmental hygiene, or with the purpose of diagnostic and analysis, the cosmetics and perfumes, and, yet, dietetic, optical, medical acoustics, dental and veterinary products.

iii. Are there any significant court or administrative judgments demonstrating the rules of product differentiation?

There are no relevant court decisions about this matter.

iv. How is software that may have some related-medical applications regulated in your jurisdiction?

Software containing medical-related applications is also considered a medical device according to ANVISA’s criteria. Therefore, beyond the same regulation concerning medical devices, software are also regulated by Law No. 9.609/98 ("Software Law"), which foresees issues related to its copyrights and licensing.

4. Cellular or tissue based products

Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device?

There is no official or binding criteria for determination whether a product is an animal or human based tissue or a medical device. However, Law No. 11.105/05 ("Biosafety Law") and also ANVISA's Regulation No. 33/06 foresee issues related to animal and human based tissues.

i. How are products composed of cells or animal/human tissue regulated in your jurisdiction?

As mentioned above, Law No. 11.105/05 ("Biosafety Law") and also ANVISA's Regulation No. 33/06 foresee issues related to animal and human based tissues in Brazil.



There is not any legal and binding criteria for determination whether the product is a medical device or cellular/tissue based product.


Not applicable.

iv. Are there any significant court or administrative judgments demonstrating the rules of product differentiation?

There are no relevant court decisions about this matter.


What are the requirements for admission (import) of medical devices into trade?

For the admission of medical devices into trade in Brazil it is required that the product is in full compliance with the Brazilian Laws and registered before ANVISA, which is the Agency in charge for the granting of authorization to commercialize the product in Brazil.

i. Is clinical assessment required for admitting (importing) medical devices into trade?

Law No. 6360/76 establishes that the register will only be granted if it is scientifically proved that the medical device is effective and secure for its purposes, and has the necessary identity, activity, quality, purity and safety.

In order to apply for the register the manufacturer must present a technical report demonstrating the effectiveness and safety of the product. In case ANVISA considers the technical report insufficient, it may request the corresponding clinical assessment.

ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for clinical assessment?

Clinical trials are not mandatory, however ANVISA may request the trials in order to check the safety and effectiveness of the medical devices.

iii. Is certification by an external certifying body required for compliance assessment of medical devices, or is a manufacturer’s declaration of conformity sufficient?

The manufacturer must present a technical report of the product when applying for the register of a medical device. However, it is not mandatory the elaboration of this by an external certifying body. The report will present all the information about the product and ANVISA will check if the medical device is in full compliance with the Brazilian legislation.

Moreover, please be informed that ANVISA regularly performs inspections in the entities that manufacture and commercialize medical devices in order to check the accuracy of the information provided in the report.


The prior register of the medical device before ANVISA is required for the admission of medical devices into trade.



There are no specific rules regarding the processing of personal data. However, there are a bill of law ("Personal Data Protection Law") regarding this issue, which will be submitted to the previous approval of the Brazilian Deputy Chamber in the following months.

i. Are there any specific rules protecting the privacy of personal data of consumers purchasing medical devices, by manufacturer/distributors?

There are no specific rules regarding this subject.



iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers?



There are no standards for reporting adverse events in Brazil or abroad.

7. Reimbursement

What is the optimal model of reimbursement of medical devices?

There is not a specific model regarding the reimbursement of medical devices. However, in certain cases Brazilian government may supply medical devices to people that can not afford them.

i. What are the rules of granting reimbursement of medical devices in your jurisdiction?

Basically, to be reimbursed, the person that requests governmental aid is supposed to attest (e.g. by means of a personal tax return) that he/she does not have enough economic condition to afford for a certain medical device.

8. Distribution

Is distribution and promotion of medical devices subject to legal regulation?

The distribution and promotion of medical devices are subject to the legal regulation of ANVISA.

i. Are there any specific regulations determining mode of business activity of medical devices distributors?

ANVISA's Regulation No. 59/00 establishes the "Good Distribution Practices". As per this regulation the distributor must comply with certain procedures in order to control the quality and keep track of the medical devices distributed.



Distributors of medical devices must obtain a document named "Certificate of Good Distribution Practices" in order to operate legally, which is issued by ANVISA. This certificate is a statement that the distributor is in conformity with all the good practices established and allows the distributor to operate.


As long as the medical device is properly registered and its trade is previously authorized, there are no specific limitations to the distribution.


Manufacturers must establish and keep procedures to control the distribution of the products in order to assure that only the approved ones will be distributed.

Furthermore, every manufacturer must keep register of distribution that include or make reference to:

- name and address of the recipient of the medical devices; - identification and quantity of products shipped and the shipping date; and - some kind of serial number that enables the manufacturer to keep track of the product.


There are specific rules for advertising and promoting medicines. However, there are no restrictions when it comes to medical devices. Although there is no regulation concerning the advertising of medical devices, as a regulatory agency, ANVISA may intervene if the publicity is considered a risk for individual and public health.

Moreover, by means of its Self-Regulatory Advertising Code, Brazilian Self-Regulatory Advertising Counsel - CONAR also may prohibit the advertising of a certain medical device that is not in conformity with the Brazilian legislation.

9. Manufacturing


The manufacturing practices are governed by ANVISA's Regulations No. 95/00 and No. 210/03. The mentioned Regulations rules the good practices of medical products manufacturing, as well as quality assurance, quality control, sanitation and hygiene.


The standards and regulations are very specifically established by the previously mentioned regulations. The manufacturer is responsible for all of its production and must assure the products are suitable for their purpose, in accordance with all the requirements established by its register, and do not jeopardize the patients by presenting inappropriate quality or effectiveness.

ANVISA's Regulations presents specific determinations for the quality of manufacturing practices. Moreover, the facilities, equipment, operational procedures and trained personnel must be previously approved by ANVISA.


The manufacturer must obtain a Certificate of Compliance with Good Manufacturing Practices from ANVISA, in order to legally perform its activities.


According to ANVISA's Regulations No. 95/00 and No. 210/03, every manufacturer must have an independent department for quality control. The department will regularly proceed with self-inspection in order to verify the compliance with the good manufacturing practices, established by ANVISA. The self-inspection reports must be available at all times, to be delivered or sent to ANVISA's surveillance department, whenever requested.


According to ANVISA's Regulations No. 95/00 and No. 210/03, the establishments manufacturing medical devices, or components of medical devices must be registered before ANVISA and obtain a Certificate of Compliance with Good Manufacturing Practices in order to legally operate.


There is no specific mode and frequency of inspection performed by ANVISA in said establishments.

10. Regulatory Guidance

How are the requirements communicated to medical device manufacturers?

The requirements applicable to medical device manufacturers are published in the Official Gazette. After the publication, manufacturers have a period to adapt to the new manufacturing conditions.

i. In what form do the laws and regulations appear that are applicable to medical device manufacturers?

Manufacturers are supposed to follow laws and regulations regarding medical devices after their publication in the Official Gazette. As mentioned above, the law / regulation may establish a period when the manufacturers must adapt themselves to the new manufacturing conditions.


ii. Are informal guidance or the opinions of regulators available to device makers, and in what form?

The laws and regulations applicable for medical devices and medicines are available at ANVISA's website (www.anvisa.org.br) and the Brazilian Government’s website (www.planalto.gov.br), and the opinions of regulators can be obtained by phone or e-mail.

Contact Information Claudio Oliveira Mattos [email protected]

Demarest e Almeida Av. Pedroso de Moraes, 1201 Centro Cultural Ohtake Sao Paulo, 05419-001 Brazil Tel 55.11.3356.1800 Fax 55.11.3356.1700 www.demarest.com.br




Medical Devices Cyprus Prepared by Lex Mundi member firm Dr. K. Chrysostomides & Co LLC 1. Definition of medical devices

What is the definition of a medical device in your jurisdiction? Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD) has been transposed into Cyprus law by means of Regulation 598/2003. A medical device is defined as: 'any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.


products incorporating both medicinal products (drugs/biologics) and medical devices? This depends on the intended use and purpose of the combination product. If the medicinal substance has ancillary action in the combination product then the product will be governed by the Medical Devices Directive. If, on the other hand, the medicinal substance has a primary action in the combination product then it will be treated as a medicinal product.

ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction? As above.


Both the drug and device components of the combination product are evaluated. Following, however, the assessment outlined in the answer to questions i/ii above, the product will be registered either as a medicinal or as a medical product.


Provisions for review, approval and marketing of medical devices and medicinal products are made available in the respective directives. With regard to medical devices in particular, the provisions of Art. 11 of Directive 93/42 have been duly transposed in national legislation and apply.


3. Borderline products Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device? As stated above, the matter is determined in accordance with the intended use and purpose of the combination product. However, there are no specific binding criteria for determining the matter. i. Are there any legal and binding criteria for determination whether the product is a

medical device or medicinal product?

N/A


N/A

iii. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? No.

iv. How is software that may have some related-medical applications regulated in your

jurisdiction?

As above.

4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device? The provisions of Medical Devices directive apply, in conjunction with Directive 2003/32 EC with respect to medical devices manufactured utilizing tissues of animal origin and Directive 2004/23 (EC) on human tissue and cells. i. How are products composed of cells or animal/human tissue regulated in your

jurisdiction?

See above.


See above.


See above.


No.



What are the requirements for admission (import) of medical devices into trade? If the medical device in question is imported from another EU Member State, there is no registration requirement with the Cyprus Medical Devices Competent Authority. If, however, the medical device is imported from a third country the manufacturer must register the product before it can be admitted to trade. The product must comply with all requirements imposed by the Law (which in essence correspond to the provisions of Directive 93/42/EC), and must bear upon it the CE marking in accordance with the relevant statutory provisions. i. Is clinical assessment required for admitting (importing) medical devices into trade?

Yes, as provided for in Art. 11 of Directive 93/42 and the Annexes thereto.

ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis

for clinical assessment? The provisions of Art. 15 of Directive 93/42 on clinical investigations apply. In addition, if clinical trials are to be conducted in Cyprus, the prior approval of the Cyprus National Bioethics authority shall be required.


The conformity assessment procedures in Art. 11 of Directive 93/42 apply.


Pre-approval is required.


Processing of personal data is regulated in Cyprus by the Processing of Personal Data (Protection of Individuals ) Law, 138(l)/2001. In broad terms the controller of personal data shall ensure that the personal data is: - processed fairly and lawfully; - collected for specified, explicit and legitimate purposes and are not further processed in a way incompatible with those purposes; - relevant, appropriate and not excessive in relation to the purposes of processing; - accurate and, where necessary, kept up to date; kept in a form which permits identification of data subjects for no longer than is necessary, in the Commissioner's discretion, for the fulfillment of the purposes for which they were collected and processed. After the expiry of this period the Commissioner may, by a reasoned decision, allow the preservation of personal data for historical, scientific or statistical purposes if he considers that the rights of the data subjects or third parties are not affected.




As above.


As above.

iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers? Personal health data are classified as sensitive data. The general rule is that the collection and processing of personal sensitive data is prohibited. However, such collection and processing can be allowed if certain conditions are met (eg. if the data subject has given his explicit consent - unless such consent has been obtained illegally or is contrary to accepted moral values or a specific law provides that consent does not lift the prohibition).


Violations of Cyprus data protection legislation are reported to and dealt with by the Office of the Commissioner for Personal Data Protection.

7. Reimbursement What is the optimal model of reimbursement of medical devices?

N/A i. What are the rules of granting reimbursement of medical devices in your jurisdiction?

N/A

8. Distribution


No.

i. Are there any specific regulations determining mode of business activity of medical devices distributors? No.


No.


No. (provided the products are in compliance with the above described legislative provisions).


No.



N/A.

9. Manufacturing



Manufacturing practices are regulated in accordance with the provisions of Directive 93/42 and the Annexes thereof.


The quality system regulations are reviewed and enforced by the Cyprus Organization for Standardization in accordance with ISO 13485: 2003 (Medical Devices - Quality management system).


Yes, as provided for in Art. 14 of Directive 93/42.


Yes.



manufacturers?

In paper and/or electronic form

ii. Are informal guidance or the opinions of regulators available to device makers, and in what form? No, but the competent Authority may provide assistance upon request.

Contact Information Alexandros Georgiades [email protected]

Dr. K. Chrysostomides & Co LLC 1, Lampousas Street 1095 Nicosia, Cyprus Tel 357.22.777000 Fax 357.22.779939 www.chrysostomides.com.cy




Medical Devices Czech Republic Prepared by Lex Mundi member firm PRK Partners 1. Definition of medical devices

What is the definition of a medical device in your jurisdiction? In line with EU Directives a medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the necessary software for its proper application, intended by the manufacturer to be used for human beings for the purpose of - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, or - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. In addition to the above definition, there are certain products specifically mentioned as being subject to the legal regime of medical devices. These include devices intended for administration of medical products, devices containing a medicinal product (including medicinal products made of human blood or plasma) which supplement the effect of the device, in vitro medical devices, custom-made medical devices, medical devices intended for clinical investigation, active implantable medical devices and accessories to medical devices.


products incorporating both medicinal products (drugs/biologics) and medical devices?

The legal regime applicable to products incorporating both medicinal products (drugs/biologics) and medical devices depends on the main function of the product. If the main function of the combination product is pharmacological, immunological or metabolic, the product is subject to legal regime of medicinal products. However, if the main function is different (e.g. mechanical or electric), then the legal regime on medicinal devices applies. Specifically, combination products intended for one-time use are subject to the legal regime on medicinal products and, at the same time, legal regulations generally applicable to the technical requirements on products.

ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction? No.


Combination products regarded as medical devices (please see point i. above) are subject to the general legal regime governing the evaluation of medical devices. In addition, the legal regulation governing evaluation of drugs (mainly Act No. 378/2007 Coll., on Pharmaceutical Products, as amended) applies analogously to the evaluating of the drug component of the combination product.



Generally, the conditions are the same as those for medical devices (for details please see Section 5 below). In addition, an expert statement regarding the safety and effectiveness of the drug component of the combination product must be issued by the competent authority, such as the European Medicines Agency (“EMEA”) or the State Institute for Drug Control (“SIDC”).

3. Borderline products Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device? Yes. The key criteria for these differentiations derive from the legal definitions of medicinal products, medical devices and other types of products. i. Are there any legal and binding criteria for determination whether the product is a


Yes, the criteria derived from legal definitions of medicinal products and medical devices as well as certain other provisions of applicable laws and regulations are binding. Additional criteria that are non-binding can be found in incidental documents issued by competent regulatory authorities.


The key criteria for differentiation between medicinal products and medical devices are the product’s main function and the main means of impact of the product. Supplementary non-binding criteria for differentiation between medicinal products and medical devices are listed in incidental documents and include the following: • Proposed manner of use of the product including route of administration, recommended

dosage and any restrictions on use, interaction, adverse effects, warnings, etc. • Qualitative and quantitative composition of the product in relation to one unit of dose or

pharmaceutical form, • Proposed manner of use of the product including route of administration, • Group of users, • Proposed labelling and information for consumers, • Information on matters relevant for the assessment of health risks associated with the

product, • Information on how the product is classified when placed on the market in other countries

(classification in EU countries has priority). iii. Are there any significant court or administrative judgments demonstrating the rules of

product differentiation? No. Moreover, the influence of past court decisions is limited in the Czech legal system as they are not generally binding and thus influence the decision making of courts of lower instance only by means of persuasiveness. Instead of publishing administrative decisions the SIDC and the Ministry of Health issue non-binding guidelines describing basic principles for product differentiation. In case of doubt it is possible to submit to the SIDC an official request to determine whether the product in question falls into the category of medicinal products or not. It is also possible to informally consult with the SIDC.


iv. How is software that may have some related-medical applications regulated in your

jurisdiction?

Software which itself forms a separate medical device is regarded as an active medical device and subject to the legal regulation of active medical devices. Software which forms an accessory to a medical device is also subject to the legal regime of medical devices, and as such it is classified separately from the main medical device. Software which is only a component and integral part of a medical device is subject to legal regulations applicable to the respective medical device.

4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device? Yes. The criteria for this differentiation derive from the legal definition of medical devices and certain other provisions of law governing medical devices. i. How are products composed of cells or animal/human tissue regulated in your

jurisdiction?

The handling of human cells and tissue is governed by a general legal framework (Act No. 296/2008 Coll., on Human Tissue and Cells, as amended). In addition, there are specialized categories of products containing human cells or tissue which are subject to different legal regimes. These are the legal regimes of medicinal products (Act No. 378/2007 Coll.), of transplantations (Act No. 285/2002 Coll.) and legal regime of medical devices (Act No. 123/2000 Coll.). The legal regime of medical devices also applies to medical devices containing animal tissue.


Yes, the criteria derived from the legal definition of medicinal products as well as certain other provisions of the applicable laws and regulations are binding.


The key differentiation principle is whether the product’s main function complies with one or more of the functions listed in the definition of a medical device.


product differentiation? No. Moreover, the influence of past court decisions is limited in the Czech legal system as they are not generally binding and thus influence the decision making of courts of lower instance only by means of persuasiveness. Instead of publishing administrative decisions, the SIDC and the Ministry of Health issue non binding guidelines describing basic principles for product differentiation. In case of doubt it is possible to submit an official request to the SIDC to determine whether the product in question falls into the category of medicinal products or not. It is also possible to informally consult with the SIDC.



What are the requirements for admission (import) of medical devices into trade? The main generally applicable requirements are (i) assessment of conformity of the device with technical requirements set out by Act No. 22/1997 Coll., on Technical Requirements on Products, as amended, and review of suitability of the device for providing health care by means of clinical assessment, (ii) the CE mark must be affixed to the device (except for custom made devices and devices intended for clinical trials), (iii) issue of written declaration on conformity of the device and (iv) notification is sent to the Ministry of Health.

i. Is clinical assessment required for admitting (importing) medical devices into trade?

Yes, except for in vitro medical devices and in specific cases where assessment of conformity based on clinical data is not suitable – in such instances the conformity assessment is done based on an assessment of its function, comparative testing and preclinical assessment.

ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for clinical assessment? Clinical assessment can be conducted without clinical trials provided that it is justified to rely on existing clinical data.


A manufacturer’s declaration of conformity is sufficient for certain types of medical devices.


The manufacturer or its representative must notify to the Ministry of Health information relating to the certification of the medical device before the device is launched on the market.




No. The general legal regulation on data processing (Act No. 101/2000 Coll.) applies.


Specific rules apply to the processing of personal data by healthcare units in connection with the provision health care (Act No. 20/1966 Coll.). However, there is no specific regulation applicable to personal data sourced by means of medical devices containing software.

iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers? No. The general legal regulation on data processing (Act No. 101/2000 Coll.) applies.


iv. What is the standard for reporting adverse events, and is reporting of events in foreign

countries required, and using what standards?

Adverse events must be reported using a prescribed form. The form and further details of the reporting are regulated by the Act on Medical Devices (Act No. 123/2000 Coll.) and a related regulation of the Ministry of Health (Regulation No. 501/2000 Coll.). Czech legal regulation requires only that the adverse event is reported to the responsible authority in the Czech Republic, i.e. the SIDC. The SIDC is responsible for transferring the information to authorities in other EU member states.

7. Reimbursement What is the optimal model of reimbursement of medical devices? Reimbursement of medical devices is currently being debated in the Czech Republic within the discussion on healthcare reform. Reimbursement based on a reference system which would provide reimbursement at an amount corresponding to that of other similar devices with comparable effects is among the most often discussed mechanisms.

i. What are the rules of granting reimbursement of medical devices in your jurisdiction?

Reimbursement of medical devices is regulated by the Act on Public Health Insurance (Act No. 48/1997 Coll.). Reimbursement generally applies to medical devices prescribed for the patient (i) to continue in the healing process, or (ii) to support stability of the patient’s health situation, to distinctively improve the patient’s health situation or to avoid its worsening, or (iii) to compensate or reduce the effects of a handicap including the replacement or modification of an anatomical structure or physiological process. The reimbursement amounts to 75% of the consumer price of the medical device. Reimbursement is provided for the basic and least expensive type of device in correlation to the extent and seriousness of the health handicap.

8. Distribution


Yes. In addition to general legal regulations on conducting business there are certain specific aspects of distribution of medical devices governed by the Act on Medical Devices (Act No. 123/2000 Coll.) and related legislation.

Promotion of medical devices is governed by the Act on Advertising (Act No. 40/1995 Coll.).

i. Are there any specific regulations determining mode of business activity of medical

devices distributors? The Act on Medical Devices (Act No. 123/2000 Coll.) sets out certain specific requirements, such as the obligation of the distributor to submit various notifications to the Ministry of Health and the SIDC.


Distribution of medical devices requires a general trade license called “Production, trade and services not included in Annexes 1 through 3 of the Act on Trades”. In addition, the commencement of distribution of medical devices must be notified to the Ministry of Health.


The person who intends to place a medical device on the market in the Czech Republic in its own name is required to (i) have its seat or place of business in a member state of the European


Union (“EU”) or (ii) appoint a single representative with a seat or place of business in an EU member state for all EU countries.

In addition, there are various notification obligations connected with the distribution of medical devices.


Yes, these obligations are set out in the Act on Medical Devices (Act No. 123/2000 Coll.) related legislation.


Advertising and promoting medical devices is subject to the general legal on advertising (Act No. 40/1995 Coll.), without any specific rules. Specific rules apply only to presentations of medical devices for which a declaration on conformity was not issued.

9. Manufacturing How are manufacturing practices regulated?

Manufacturing practices are regulated by secondary legislation implementing the Act on Medical Devices (Act No. 123/2000 Coll.). In addition, technical requirements are set out in technical norms developed and published by Czech Office for Standards, Metrology and Testing.

i. Are there any specific standards or regulations determining the quality of manufacturing

practices?

Yes. Governmental Regulation No. 336/2004 Coll., sets out requirements concerning design, construction and manufacturing of medical devices. In addition, criteria for overall quality management of medical devices production are set out in EN ISO13485:2003.


Fulfillment of the respective requirements by the manufacturers is reviewed by authorized persons who issue certificates on compliance to the manufacturers. Compliance with applicable regulations is a part of the assessment of conformity for each type of medical device and a prerequisite for placing the device on the market.


Yes. The manufacturer must submit the respective notification to the Ministry of Health.

iv. Are these establishments inspected regularly by government regulators or authorized

bodies, and what is the mode of such inspections?

Yes. Inspections aimed at the manufacturing process are conducted by authorized persons established as non-governmental entities. The inspections include regular audits as well as inspections, which are not notified to the manufacturer in advance.


10. Regulatory Guidance

How are the requirements communicated to medical device manufacturers?

The requirements set out in legal regulations are published in the official Collection of Laws of the Czech Republic. Technical norms are published in the Bulletin of the Czech Office for Standards, Metrology and Testing.


manufacturers?

Legally binding regulations comprise laws, governmental regulations, notices and communications of the ministries.

ii. Are informal guidance or the opinions of regulators available to device makers, and in what form? Yes. Informal guidelines are issued by regulators, mainly by the Ministry of Health and the SIDC. The guidelines are published in bulletins issued by the regulators, which are also posted on their web sites.

Contact Information Jan Kohout [email protected] Monika Mašková [email protected]

PRK Partners Jáchymova 2, 110 00 Prague 1 Czech Republic Tel 420.221.430.111 Fax 420.224.235.450 www.prkpartners.com/en/




Medical Devices Estonia Prepared by Lex Mundi member firm LAWIN 1. Definition of medical devices

What is the definition of a medical device in your jurisdiction? Medical device is defined as any instrument, apparatus or appliance, software, material or other product used on humans, whether used alone or in a combination, including software intended by the manufacturer specifically for use either on diagnostic or treatment purposes, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which is used for the purpose of: • diagnosis, prevention, monitoring, treatment or alleviation of disease; • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; • investigation or modification of the anatomy or of a physiological process or replacement of a part

of body; • control of conception.



If a medical device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, the relevant medical device is governed by the Medicinal Products Act and by those requirements of the Medical devices Act that concern safety and performance related features of the device.

Where a medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in the Medicinal Products Act and which is liable to act upon the body with action ancillary to that of the device, only the requirements of the Medical Devices Act apply to the medical device.

ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction? No.


Please see response to Q 2 (i) above.

iv. What are the general conditions for review, approval and marketing the combination

product?



Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device? i. Are there any legal and binding criteria for determination whether the product is a


If the product complies with the definition of the medical devices (see our response to Q 1), the Health Board has the right to define the product as a medical device.


See our response to Q 3 (i) above. iii. Are there any significant court or administrative judgments demonstrating the rules of

product differentiation?

We are not aware of any such judgments.

iv. How is software that may have some related-medical applications regulated in your jurisdiction?

If the software corresponds to the definition of the medical devices (see our response to Q 1), the Health Board has the right to define the software as a medical device.

4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device? i. How are products composed of cells or animal/human tissue regulated in your

jurisdiction?

The terms and conditions of treating and implanting cells, tissues and organs of human origin are set forth under the Cells, Tissues and Organs Treatment and Implantation Act. Cells, tissues and organs can be treated and implanted only by a provider of special medical services holding the relevant activity licenses.


No.


N/A.


We are not aware of any such judgments.



What are the requirements for admission (import) of medical devices into trade? i. Is clinical assessment required for admitting (importing) medical devices into trade?

Yes.

ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis

for clinical assessment? Clinical trials are required in case of implantable medical devices and class III medical devices, except in case depending on existing clinical information is duly justified. However, clinical trials may be needed also regardless of the class of the device. Furthermore, clinical trials are carried out only in case testing the medical device on humans is the only way to obtain information about its efficiency, safety and clinical benefit.


The applicable conformity evaluation procedure is chosen by the manufacturer depending on the type of the device to be evaluated. The authorized representative of the manufacturer is entitled to carry out type evaluation, verification, declaration of conformity and drafting of a written confirmation. An external notified body has to be involved in case of medical devices to be placed on the market in sterile condition, class I medical devices with measuring function and class IIa, IIb and III and dangerous in vitro diagnostics medical devices.


Post-launch notification is sufficient.

6. Processing of personal data (privacy)

What are the rules of processing of personal data in a number of activities performed by manufacturer/s distributors/ healthcare units with the use of medical devices.


purchasing medical devices, by manufacturer/distributors? There are no specific rules. General personal data protection laws apply.

ii. Are there any specific rules of processing of personal data sourced by means of medical

devices containing software, by healthcare units?

There are no specific rules. General personal data protection laws apply.

iii. Are there any specific rules of

Medical Devices · iii. Are establishments manufacturing medical devices, or components of medical...

Documents

Transcript of Medical Devices · iii. Are establishments manufacturing medical devices, or components of medical...