Medical Devices 6 Step Guide to Global...

Medical Devices 6 Step Guide to Global Markets:

The BRIC Countries + Japan

Intertek Cleeve Road, Leatherhead, Surrey KT22 7SB UK

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Medical Devices - 6 Step Guide to Global Markets: The BRIC Countries + Japan

Contents

Contents ............................................................................................................. 1 Introduction ......................................................................................................... 1 Overview: The BRIC Countries + Japan ................................................................. 2 Six-Step Guide to Global Markets: The BRIC Countries + Japan ............................ 4

Brazil ............................................................................................................... 4 Russia .............................................................................................................. 7 India .............................................................................................................. 11 China ............................................................................................................. 13 Japan ............................................................................................................. 16

Conclusion ........................................................................................................ 19 About Intertek ................................................................................................... 19

Introduction

With a global population that is both living longer and experiencing an increasing rate of chronic disease, a rising demand for and subsequent improved access to quality healthcare is being witnessed in countries around the world. The global market for medical devices continues to grow rapidly, creating opportunities for U.S. medical device manufacturers to expand their sales efforts into emerging markets worldwide. To ensure a smooth, efficient, and successful sales process in these world markets, however, a thorough understanding of the regulatory environment and product approval process unique to each country is critical.

Intertek’s strategically-developed “Six-Step Guide to Global Markets” is designed to assist manufacturers in understanding, approaching, and securing the approval of medical devices for sale within global markets. Specifically, Intertek’s unique six-step framework streamlines entry into the global medical device market by addressing each country’s:

1. Regulatory background

2. Product assessment/scope

3. Device classification system

4. In-country representation requirements

5. Registration requirements, and

6. Submission requirements

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It can take as long as 12-36 months to secure approvals for a medical device based on the complexity of the device, the specific processes and documentation involved, and the layers of approval required. Manufacturers are, therefore, encouraged to familiarize themselves with and address each of the six sequential steps in Intertek’s strategic methodology to help ensure accurate, efficient, and trouble-free market entry.

This white paper will aid significantly in that process by discussing the six steps to global markets as well as familiarizing readers with the specific testing, documentation, and regulatory requirements along with the challenges and opportunities associated with selling medical devices into five of the largest and most rapidly-growing global markets for these products - Brazil, Russia, India, China, and Japan - an important and powerful block of nations also known as the ‘BRIC Countries + Japan.’

Overview: The BRIC Countries + Japan

The BRIC countries are currently recognized as the largest players in the global medical device arena behind the U.S., European Union (EU), and Japan based on their physical size, population, and the annual growth rate of their medical device markets. Intertek experts offer the following snapshots of the medical device market within each of the BRIC countries:

• Brazil has the largest economy and medical device market in Latin America. It is the second largest private health insurance sector in the Americas after the U.S., covering approximately 25% of the population. Investments in healthcare are among the Brazilian government’s biggest priorities and funding is available to develop and support local medical device manufacturers. Generally speaking, local medical device manufacturers are trying to close the technology gap between themselves and foreign manufacturers by launching innovative technology and are backed by government incentives aimed at improving product quality and expanding exports. In addition to local competition, a key challenge faced by foreign manufacturers seeking to penetrate the Brazilian market will be very high taxation and tariffs, the structure of which varies according to the product, making it almost impossible to know in advance what the landed cost or end-user price will be.

• Russian medical device manufacturers are generally small and undercapitalized and tend to produce obsolete products; they can only compete with Western products in terms of cost. Though the country traditionally has a strong scientific research base, it has little or no experience in commercializing new products. In January 2013, however, the government approved a strategy that will support the development of

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innovative products and their introduction into the healthcare system through 2025.

• In India, detailed regulation of medical devices remains a work in progress. To date, a number of implantable and sterile medical devices have been added to the Drugs and Cosmetics Act, bringing them under regulatory control, and new guidelines for sterile medical devices came into force on March 1st, 2006. The government has been working on a revision of rules which recognizes the need to consider medical devices as a separate category; the new regulations were to have been published as the Drugs, Cosmetics and Medical Device bill in the winter 2012 parliamentary session, but doubt remains over the future of the bill amidst reports that it does not meet the requirements of the medical device industry in its present form. In the meantime, the medical device industry has called on the government to come up with an interim regulatory mechanism in the form of a guidance document.

• The Chinese medical device industry has recently entered a crucial step of its developmental evolution by upgrading and harmonizing its system with international requirements. Although the medical device market in China offers important opportunities and expanding benefits, device manufacturers are facing several issues, from tougher compliancy regulations and business practice scrutiny to increased competition from both local and global players.

The emerging ‘BRIC’ economies of Brazil, Russia, India, and China have not only become lucrative, high-growth markets for medical devices based on increased health awareness among residents, but have also become attractive investment regions for multinational medical device companies seeking offshore business operations and production. Economically, the growing middle-class in the BRIC nations has reached more than one billion in population, triggering a continued surge in value-added lifestyle. The combined GDP of the BRIC countries was about 31% of the global economy in 2009 based on their increased penetration of the global outsourcing and offshoring market. As a result of these realities, Intertek experts confirm that the BRIC nations offer the most immediate economic possibilities and therefore represent the most productive use of a medical device manufacturer’s time, resources, and investment into global markets today. The efficient navigation of these countries’ legislative and medical device landscapes is critical, however, and is outlined below in Intertek’s strategic ‘Six-Step’ roadmap to approaching and securing the approval of medical devices for sale within global markets.

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Six-Step Guide to Global Markets: The BRIC Countries + Japan

Brazil

Six-Step Approach to Global Sales: Brazil

Overview of Market Environment and Keys to Sale of Medical Devices

Overview: Market Snapshot

In terms of vital measures, Brazil’s total population of 199 million is growing at .9% annually and 6.7% of the population is 65 or older. The country’s healthcare expenditures represent 8.9% of its GDP, for a per capita health spend of $1,009 as of 2013. In 2012, the Brazilian medical device market was valued at approximately $7.9 billion (U.S.), with medical device imports estimated at $2.8 billion and overall market growth estimated at 15%.

Regulatory Background Medical devices in Brazil are regulated by the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária), also known as ANVISA

Product Assessment Per Annex I of “Brazilian Resolution RDC 185/2001,” a medical device is defined as: “A product for use in health, such as equipment, apparatus, material, article or system of use in health or implementing medical, dental or laboratory, for prevention, diagnosis, treatment, rehabilitation or contraception, and not using pharmacological, immune, or metabolic means to perform their main function to humans, may however be assisted in his duties by such means.”

Device Classification Brazilian Resolution RDC 185/01 establishes the following classes of medical devices:

• Class I • Class II • Class III • Class IV

Class I and II include low and medium risk devices. Class III and IV include higher-risk devices. Helpful Hint: With four device classes, Brazil’s classification system is slightly different than that of the U.S. FDA. However, Brazilian Resolution RDC 185/01 is similar to European Medical Device Directive 93/42/EEC and Classes

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I, II, III, and IV in Brazil are similar to Classes I, IIa, IIb, and III in the European Union.

In-Country Representation

Medical device manufacturers should appoint a company that holds a Company Working Allowance permit from ANVISA as the Brazil Registration Holder (BRH). Helpful Hint: Similar to the European Union, companies without a location in Europe must appoint an Authorized Representative to act on their behalf

Registration Requirements It is mandatory to register all medical devices listed in RDC No. 185, except those products referred on items 2, 3, and 12 of Part 3 of this regulation. Manufacturers should:

• Prepare a Technical File that includes information on the device

• Obtain a Certificate of Free Sale (CFS) or a device registration certificate proving home-country approval OR demonstrate evidence of registration in two other markets and justify why the device does not have home-country approval

Helpful Hint: The registration requirements are similar to the European Union and the U.S. in that all devices have to be registered Certain devices require INMETRO Certification, including medical devices sold in Brazil that fall under the scope of the following standards:

• NBR IEC 60601 series • NBR ISO 6875:1998: Dental patient chair • NBR ISO 7785-2:2004: Dental handpieces - Part 2:

Straight and geared angle handpieces • NBR ISO 9919:1997: Medical electrical equipment -

Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

• NBR ISO 11195:2000: Gas mixers for medical use - Stand-alone gas mixers

• NBR ISO 8835-2:2010: Inhalational anesthesia systems - Part 2: Anesthetic breathing systems

Helpful Hint: This process is quite similar to the European Union

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and the U.S. FDA's test data evaluation and policy of accepting test reports

Preparation & Submission

Manufacturers should: • Submit the registration application and Technical

File to ANVISA through BRH. ANVISA reviews the registration application. High-risk and innovative devices must meet ANVISA clinical trial requirements. ANVISA usually accepts clinical trial results previously conducted in other markets as adequate to meet such requirements.

Helpful Hint: Technical files required by ANVISA resemble documents required by the U.S. FDA. Applicants that have already prepared Technical Files for CE Marking or U.S. FDA 510(k) submissions usually may reuse similar information to prepare their Brazilian Technical Files.

• Once approved, ANVISA will publish registration number in the Diário Oficial da União (DOU). Both ANVISA device registrations and INMETRO certifications must be renewed every five years.

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Russia

Six-Step Approach to Global Sales: Russia



In terms of vital measures, Russia has a population of 143 million and a per capita healthcare spend of $42. The Russian market for medical equipment and supplies is valued at $6 billion (U.S.) and 73% of the country’s healthcare products are imported (though the country is enacting initiatives to stimulate internal R&D and manufacturing within its borders). According to the World Health Organization, Russia’s 2011 total expenditure on health per capita is $1,316, and represented 6.2% of the country’s GDP.

Regulatory Background Roszdravnadzor (Federal Service for Control of Healthcare and Social Development in the Russian Federation) oversees all domestic and imported medical devices in Russia.

Product Assessment

Products for medical application in the territory of the Russian Federation are defined as those which are designed for:

• Preventive treatment, diagnostics (in vitro), sickness treatment, after-care treatment, medical procedures, medical research, replacement and modification of parts of human body tissues, organs, recovery or compensation of disrupted or lost physiological functions, impregnation control

• Production of effect on human organism so that their designated purpose is not implemented through chemical, pharmacological, immunological, or metabolic interaction with human organism, but of which effect can be supported by such means

Device Classification Roszdravnadzor Order No. 735 and Rosstandart 51609-2000 define the type of the medical device according to Decree No. 4n and have established the following classes:

• Class I - low-risk • Class IIa - medium risk • Class IIb - increased risk • Class III - high-risk

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Manufacturers should search for equivalent medical devices already approved for sale in the Russian Federation. Helpful Hint: This classification system is equivalent to that of European Union and is comparable to that of U.S. FDA. This is similar to the U.S. FDA 510(k) or Premarket Notification, wherein substantial equivalence is to be claimed to a previously-cleared device (predicate device).

In-Country Representation Manufacturers should appoint an Authorized Regulatory representative to co-ordinate the registration process in Russia; this is only needed for devices classified as Class IIa, IIb, and III. Helpful Hint: This is similar to the European Union in that companies without a location in Europe must appoint an Authorized Representative to act on their behalf. The difference with respect to the U.S. is that for a company located outside the U.S., a “U.S. Agent” must be appointed and the company and device should be registered. No certificate is issued by the FDA, but the company is subject to FDA inspections for QSR compliance, and manufacturers should be prepared with documentation in this regard.

Registration Requirements

Manufacturers are advised to: • Meet with officials to determine the testing

requirements for the device. • Submit an application for permission to import

testing samples. • Conduct testing at government authorized testing

and medical centers within Russia. • Receive results of testing and medical reports.

Helpful Hint: This process is quite different from that of U.S. regulatory processes, where most Class I devices are exempt from Pre-Market Notifications, most Class II and some Class III devices are subject to FDA 510(k), and most Class III devices are subject to PMA. Russia's process is also different from the European Union, where a Technical File is typically needed for all device classes.

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Testing must be performed by local expertise centers and hospitals and the results must be included in the registration dossier. All applicable quality, safety, and efficacy testing should be performed at Authorized Expertise Centers and Hospitals in Russia; testing in Russia is needed even if the equivalent testing has been performed to international standards outside of Russia. If expert reviewers determine that additional clinical testing of a device is necessary, Roszdravnadzor will issue a permit to conduct clinical trials and will temporarily suspend the registration process. Once the results of clinical trials are obtained, the results must be submitted to Roszdravnadzor and followed up with an application for continuation of the registration process. Helpful Hint: These testing requirements differ from the European Union and the U.S., where testing to harmonized standards is generally accepted. Overall, the biggest hurdle for foreign manufacturers seeking device registration/approval in Russia is that it relies on a system of product testing as a tool for determining safety and efficacy. Such testing is also required for products that already possess CE marking, U.S. Food and Drug Administration 510(k) clearance, or other national approval.

Preparation & Submission

Manufacturers should: • Prepare a Registration Dossier that includes all

technical details about their device, including testing results.

• Obtain proof of home country approval using a CFS (Certificate of Free Sale) or CFG (Certificate to Foreign Government).

• Submit dossier and CFS or CFG to Roszdravnadzor. All technical documents must be submitted in Russian and the registration certificate does not expire unless changes are made to the device, manufacturing facility address, or contact details. Helpful Hint: The requirement to have testing requirements conducted in Russia is stringent compared to U.S. FDA and European Union Regulatory approval processes.

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• If the dossier is approved, Roszdravnadzor issues a

Registration Certificate • To clear medical devices through Russian Customs,

products must have one or both of the following certificates (which can only be issued after the Registration Certificate has been obtained):

o Sanitary-Epidemiological Conclusion (Hygiene Certificate)

o GOST-R Quality Certificate • Apply for a Declaration of Conformity (DoC)

certificate

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India

Six-Step Approach to Global Sales: India



In terms of vital measures, India’s population of 1.26 billion is growing at 1.6% annually. There are 400 million middle income consumers in India and the country’s healthcare market was valued at $35 billion in 2011. India’s medical device market was valued at $2.7 billion in 2011 and is growing at an estimated rate of 15.6%.

Regulatory Background The import, manufacture, sale, and distribution of medical devices in India are regulated under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices.

Product Assessment

"Medical devices" are defined as instruments, equipment, tools, materials and other objects, including the software attached to them, that are designed to be used either independently or in combination on the human body in the:

• Prevention, diagnosis, treatment, monitoring, or remission of diseases

• Diagnosis, treatment, monitoring, remission, or compensation of injury or physical disability

• Research, replacement or adjustment of anatomical or physiological process

• Control of pregnancy

Device Classification Identify if the device is in the list of "Notified Medical Devices" or IVD's that require medical device registration in India (In the case of an IVD that is not on the list of regulated products, skip to Step 5) Helpful Hint: The List of Notified Medical Devices is available at http://cdsco.nic.in/writereaddata/list%20of%20notified%20medical%20device.pdf (note: country links are periodically rendered inactive; reach out to your Intertek representative for an updated

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http://cdsco.nic.in/writereaddata/list%20of%20notified%20medical%20device.pdf

http://cdsco.nic.in/writereaddata/list%20of%20notified%20medical%20device.pdf


link should this become defunct)

In-Country Representation If the device is regulated, an India Authorized Agent should be appointed to interact with CDSCO. Appoint an agent responsible for pre-certification and post-market surveillance inquiries. The authorized agent must maintain a drug wholesale license and be a resident of India OR maintain a place of business there.

Registration Requirements Only notified medical devices are regulated in India. The following medical devices are notified under the Drugs and Cosmetics Act:

• Catheters, heart valves, cardiac stents, etc. For the import of medical devices, the manufacturing site and products are required to be registered. Helpful Hint: Guidelines and FAQs on the registration and import of medical devices in India are available at http://cdsco.nic.in/writereaddata/FAQ-IMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf (note: country links are periodically rendered inactive; reach out to your Intertek representative for an updated link should this become defunct)

Preparation & Submission Manufacturers should: • File an application for device registration (Form 41). • Identify a distributor in India and file an application

for an import license (Form 10). For import of medical devices, the manufacturing site and medical device products are required to be registered with the Indian drug regulatory agency (e.g., the Central Drugs Standards Control Organization).

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http://cdsco.nic.in/writereaddata/FAQ-IMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf




China

Six-Step Approach to Global Sales: China



A $120 billion healthcare stimulus initiated in 2009 (and ultimately driven to achieve universal healthcare for all Chinese citizens by 2020) spurred investment in infrastructure, creating tremendous opportunity for manufacturers; since then, China’s healthcare expenditures represent 5.2% of its GDP and the country’s annual per capita healthcare spend is $373 as of 2013. In terms of vital measures, China’s current per capita spend on medical devices is $12.60, the country imports 70% of its high-end medical devices, and the current market for medical devices in China is estimated to be just under $17.1 billion (U.S.) as of 2013, making China the fourth largest market in the world and the second largest in Asia behind Japan. For the 2013-18 period, Espicom estimates that continued market growth will average 20% per annum in local currency, equivalent to a U.S. dollar CAGR of 18.7%, rendering China one of the fastest growing markets in the world.

Regulatory Background Previously called the ‘State Food and Drug Administration’ (SFDA), China’s regulatory body for medical devices was rebranded and restructured as the ‘China Food and Drug Administration’ (CFDA) as of March 2013

Product Assessment "Medical devices" are defined as instruments, equipment, tools, materials and other objects, including the software, that are designed to be used on the human body in the:

• Prevention, diagnosis, treatment, monitoring or remission of diseases

• Diagnosis, treatment, monitoring, remission, or compensation of injury or physical disability

• Research, replacement or adjustment of anatomical or physiological process

• Control of pregnancy

Device Classification Manufacturers should determine the classification of their medical device in China using the China Food and Drug Administration (CFDA) Order No. 15: “Provisions for Medical Device Classification,” which establishes the following classes:

• Class I - Devices for which safety and effectiveness

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can be ensured through routine administration (products such as rehabilitation techniques, disinfecting devices and apparatus, etc.)

• Class II - Devices for which further control is required to ensure their safety and effectiveness

• Class III - High-risk devices such as those implanted into the human body, or used for life support or sustenance, or those that pose potential risk to the human body (such as implanted artificial internal organs and infant care devices)

Helpful Hint: China’s classification system is similar to that of the European Union and the U.S. in that there are 3 device classes. However, a Class II device in the U.S. or a Class IIa/IIb device in the EU may be classified as Class III in China.

In-Country Representation Medical device manufacturers should appoint a "Legal Agent” and “After Sales Agent" to co-ordinate CFDA device registration, per the following guidelines:

• Agents must be legal residents of China or maintain local business presences in China

• The Legal Agent interacts with the CFDA during the device registration process and assists in obtaining registration renewal every four years

• The After Sales Agent is responsible for reporting all incidents related to the device to Chinese authorities following registration and commercialization of the device in China

Helpful Hint: For greater ease with this step, reach out to your Intertek representative for assistance in finding and appointing accredited Legal and After Sales Agents in China

Registration Requirements Medical device manufacturers are required to prepare and submit an application to the CFDA for an Import Medical Device Registration Certificate (IMDRC). Proof of registration in the country of origin is required. Helpful Hint: This is different compared to the U.S and European Union, where device approvals and registration are strictly based on the evaluation carried out by the FDA or Notified Bodies

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Manufacturers must submit the device to CFDA for testing, which is carried out by the CFDA Medical Device Quality Supervision and Inspection Center. Clinical trials conducted in China could be required for devices that do not have regulatory approval in another country as well as for high-risk devices. Except in the cases of new implant products and in-vitro reagents, foreign clinical data are mostly accepted and local investigation could be exempted in most circumstances. China Compulsory Certification (CCC) is applicable to some medical devices with electrical components for safety conformity. As of May 2013, CCC requirements noted exemptions for eight categories of products, including heart-lung machines, medical x-ray diagnostic equipment, and ECG devices. However, if the device requires CCC Mark Certification, it must be obtained through testing of the device in China-based labs. An on-site audit of the legal manufacturer is also required.

Preparation & Submission Manufacturers should: • Prepare a Chinese Registration Standard dossier,

including testing results, and submit it to the CFDA for approval. Foreign manufacturers must submit quality system certificates - e.g., ISO 13485 or proof of compliance with U.S. FDA Quality System Regulations, which are adequate to meet CFDA quality management system requirements. The language of submission should be Chinese.

The CFDA reviews the application and issues an IMDRC certificate, which is valid for 4 years. Re-registration is necessary in cases such as:

• Manufacturer change • Manufacturing site change • Product name, model or components change • Indications for use change • Chinese registration standard (YZB) change

Helpful Hint: Advance planning by manufacturers is recommended, as the entire process can take up to 12 months for a Class I device, 18 months for a Class II device, or as much as 36 months for a Class III device

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Japan

Six-Step Approach to Global Sales: Japan



With a population of 127.2 Million (23% of whom are 65 or older, a segment which will represent 40% of the population by 2050), Japan is the 10th most populated country in the world. In terms of vital measures, healthcare expenditures represent 8.5% of the country’s GDP and per capital healthcare expenditures were $3,120 as of 2013. In 2013, Japan’s medical device market was valued at $29.8 billion (with an annual growth rate of 2.5% through 2018) and ranked as the second largest medical device market behind the U.S.

Japan (continued) Regulatory Background

The Pharmaceuticals and Medical Devices Agency (PMDA) is the Japanese regulatory agency working together with the Ministry of Health, Labor and Welfare to protect the public health by assuring the safety, efficacy, and quality of pharmaceuticals and medical devices. The Pharmaceutical Affairs Law (PAL) covers regulations on pharmaceuticals, medical devices, and cosmetics.

Product Assessment Medical devices are defined as an instrument or apparatus intended for use diagnosing, curing, or preventing diseases in humans or animals, or intended to affect the structure or functions of the bodies of humans or animals.

Device Classification Manufacturers should determine their medical device classification according to Japanese PAL and JMDN codes:

• Class I - General Medical Devices, which are defined as those devices where the potential risk is almost insignificant in the case of malfunction or side effect (examples include scalpels, X-ray film, etc.)

• Class II - Specified Controlled Medical Devices and Class II - Controlled Medical Devices, which are defined as those devices presenting potential risk in the case of malfunction or side effect (examples include MRIs, electronic sphygmomanometers, etc.)

• Class III - Highly Controlled Medical Devices, which are defined as those devices where the potential risk is relatively high in the case of malfunction or

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side effect (examples include hemodialysis equipment, artificial bones and joints, balloon catheters, etc.)

• Class IV - Highly Controlled Medical Devices, which are defined as those devices where the potential risk is life-threatening in the case of malfunction or side effect (examples include pacemakers, artificial cardiac valves, stents, etc.)

Helpful Hint: This classification system is different when compared to the U.S. and European Union, where devices are classified into Class I, II, and III.

In-Country Representation Manufacturers should appoint a Marketing Authorization Holder (MAH or D-MAH) to manage and control the device registration in Japan. Requirements of an MAH and D-MAH are as follows:

• Must be based in Japan • Must be formally licensed by the prefecture of

residence • Must employ at least three staff members: general

manager, quality manager and safety manager • Must implement GQP and GVP systems

Helpful Hint: The MAH and D-MAH have much more legal, logistic, and regulatory responsibility than a European Authorized Representative or a U.S. FDA Agent. Generally, a domestic Japanese MAH is the holder of the Pre-market Approval (Shonin) and Pre-market Certification (Ninsho). However, through the “Foreign Special Approval System” under the new Pharmaceuticals Affairs Law, the foreign manufacturer is the applicant of the registration and holder of the Pre-market Approval and Premarket Certification.

Registration Requirements To market medical devices in Japan, the MAH must register the device through the following procedures:

• Pre-market Submission (Todokede) • Pre-market Certification (Ninsho) • Pre-market Approval (Shonin)

Preparation & Submission Manufacturers should apply the following guidelines by product class:

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Class I - General Medical Devices • Submit Pre-Market Submission to PMDA • Self-declaration with no assessment or certificate

issued by PMDA Class II - Specified Controlled Medical Devices

• Submit Pre-Market Certification application to a Registered Certified Body (RCB) authorized to issue certifications

• Involves QMS audit and certificate issuance by RCB Helpful Hint: The Pre-market Certification (Ninsho) is quite similar to European CE Marking using a Notified Body. Each Specified Controlled Medical Device must apply internationally harmonized standards as is the case with CE Marking Class II - Controlled Medical Devices Class III - Highly Controlled Medical Devices Class IV - Highly Controlled Medical Devices

• Prepare Pre-Market Approval application as well as registration dossier in Summary Technical Document (STED) format. Submit documents to PMDA.

• Involves QMS audit by PMDA. On-site audits required for new devices, as well as Class IV devices and those requiring clinical investigations.

Japan's Pharmaceutical Affairs Law requires all forms related to the marketing application to be submitted in Japanese.

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Conclusion

In the rapidly-expanding global market for medical devices, preparation is key. Manufacturers who are well-informed relative to the specific regulatory and product approval processes in each country will be best positioned to ensure their success and speed to market. Based on their large populations, strong and/or rapidly-strengthening economies and infrastructures, and projected annual growth rates for medical technology, the BRIC + Japan countries currently represent some of the most attractive global sales opportunities in the world for medical device manufacturers; however, an in-depth understanding of the unique and often complex regulatory environments and product approval processes in each country represents a critical step that manufacturers must address in a thorough and strategic manner in order to maximize their participation.

About Intertek

Intertek is the leading quality solutions provider to industries worldwide. From auditing and inspection to testing, training, advisory, quality assurance, and certification, Intertek adds value to customers’ products, processes, and assets. With a network of more than 1,000 laboratories and offices and over 36,000 people in more than 100 countries, Intertek supports companies’ success in a global marketplace. Intertek helps its customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide.

Intertek consulting services provided for medical devices are carried out by medical device experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body activities.

For more information on specific testing and certification information, please contact Intertek at

+44 1372 370900, email [email protected], or visit our website at www.intertek.com.

This publication is copyright Intertek and may not be reproduced or transmitted in any form in whole or in part without the prior written permission of Intertek. While due care has been taken during the preparation of this document, Intertek cannot be held responsible for the accuracy of the information herein or for any consequence arising from it. Clients are encouraged to seek Intertek’s current advice on their specific needs before acting upon any of the content.

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