Mutual Recognition Agreements (MRA) betweenthe EU and the USA and Australia have beenestablished to enable conformity assessmentbodies of market A to approve devices for market B under the legis lation of market B, andvice versa.

The Global Harmonization Task Force (GHTF)works on the effective internationalharmonization in the approval of medical devices.Many countries implementing new medicaldevice regulations base their legislation on GHTFguidances.

However, all these markets still have, in addition,their specific requirements and rules. In general,approval is still very much regionalized andfragmented, although the approach got closer.

Who is this bulletin applicable to?Companies manufacturing or exporting medicaldevices and in vitro diagnostic medical devicesfor the worldwide market.

Addressed Markets Page

Russian Federation 1

USA 2

Canada 3

Brazil 3

Japan 3

China 4

Taiwan 5

Hong Kong 5

Singapore 6

Australia 6

Global 7

TÜV SÜD enables accelerated market entry in many countries through agreements withauthorities and testing institutes.

Manufacturers benefit from being able to submitfewer documents or from the consolidation ofproduction inspections.

Russian FederationThe approval of medical devices in Russia isdivided into different parts: registration, GOST-Rcertification and Hygiene Certification (SanitaryEpidemiological Conclusion).

The “Federal Service for Control over Healthcareand Social Development” (Roszdravnadzor) is the competent authority in Russia for theregistration of medical devices. The departmentreviews applications and decides on acceptingthe documents for registration. Afterwards itdefines which tests (usually technical, clinicaland toxicological tests) of the medical devicehave to be performed in accredited clinicalcenters and test laboratories. The last step ofregistration is the evaluation of the test resultsand issue of the registration certificate. Thevalidity of the certificate is not limited.

The GOST-R certification is a separate procedureand starts after registration has been completed. After registration, the medical device usually has to be tested by the “Federal Agency forTechnical Regulation and Metrology” (former“State Committee for Standardization”-Gosstandart) in accredited certification centers.The GOST-R certificate is limited for one or threeyears and can also be issued for a lot.

Globalization of Medical Device Approval

Med-InfoRegular Information Bulletins for the Medical Device Industry

TÜV SÜD Product Service GmbH

Product Service

For medical devices and materials that havecontact with the patient tissue it is necessary to obtain a hygiene certificate.

Hygienic assessment is implemented by theDepartment of “State Sanitary andEpidemiological Surveillance” of the Ministry ofHealth which reviews the results of hygienictests. The “Sanitary Epidemiological Conclusion”(Hygiene Certificate) is the document whichconfirms that a product complies with Russiansanitary requirements. It is issued for the period of five years.

Most medical devices imported by Russia areVAT (18%) exempt.

TÜV SÜD and its partners can provide you withall required services including registration,GOST-R certification and hygienic certification.

USAClass I and II medical devices requiring clearancefor US market entry can only attain acceptancevia a pre-market notification procedure,otherwise referred to as 510(k). The term 510(k)originates from section 510(k) of the FederalFood, Drug, and Cosmetic Act. A 510(k)submission is based on comparison of the newdevice with devices already legally marketed inthe USA, which allows the US Food and DrugAdministration (FDA) to determine whether adevice is safe and effective. Medical devicemanufacturers are required to submit a 510(k) ifthey intend either to introduce a device forcommercial distribution in the US for the firsttime, or to reintroduce a device that has beensubstantially modified. 510(k) was previouslyconducted by the FDA only. Starting in 1996, thesystem was revised to allow several third-party

testing institutes to carry out the administrativeand substantive review of the documentation onbehalf of the FDA and thus to allow a faster and more efficient market access. TÜV SÜD wasalready authorized by the FDA in 1996 to perform third-party reviews for all eligible devices. The advantage for you is direct contact andcommunication throughout the review process.The timeline is 30 days for our review andanother 15 days for the final FDA review. The final review is comparable to the internalprocedure of the FDA. Their reviewer also has toforward a recommendation to the supervisor forfinal decision. The FDA fee of approx. $ 4,000 is only relevant if you submit the 510(k) directlyto the FDA.

After product clearance, the FDA can carry out aproduction site inspection at any time. As a rule,this takes four working days and encompassesmanagement, development, corrective andpreventive action, as well as production andprocess control.

Under the Mutual Recognition Agreementbetween the EU and the USA (MRA) as well asunder the FDA’s Modernization Act, manufacturerscan have routine inspections done by TÜV SÜDcombined with an audit under EU regulation.When the FDA announces the inspection, youmay respond that you would like to participate inthe Accredited Persons (AP) Program.Alternatively you can initiate an AP inspectionwith the FDA at any time. We also offer pre-audits (i.e. mockaudits) based on the FDAregulations.

Moreover, TÜV SÜD is a Nationally RecognizedTesting Laboratory (NRTL) for the US market and offers to test your device according to e.g.

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UL 60601-1. The basis for NRTL medical devicecertification is the testing of electrical andmechanical safety according to IEC 60601-1. You can get a complete testing pack ageincluding production inspections from onepartner. If you already are a customer in thecontext of system certification, a yearly audit canbe combined easily and cost-effectively with oneof these production inspections.

In addition, we will test your device according tothe US-specific EMC requirements.

CanadaThe Canadian Medical Devices Regulationsclassify medical devices similar to the EUMedical Device Directive, a main differencebeing that Canadian law integrates IVD productsand active implants. Since 1 January 2003,Canadian law requires that manufacturers ofclass II, III, and IV medical devices and IVDdevices have a quality management system thatmeets the requirements of ISO 13485 in order toobtain a license to sell their devices in Canada.Only a CMDCAS certificate issued by a SCCaccredited CMDCAS registrar will be accepted.Manufacturers of medical devices licensed forsale in the Canadian market have to renew theirdevice licenses annually until 1 November andtherefore need to submit a copy of theirCMDCAS certificate.

TÜV SÜD was the first registrar accredited by theStandards Council of Canada (SCC) to performISO 13485 CMDCAS certification.

Over 70 specially trained and authorized auditorsfrom TÜV SÜD ensure CMDCAS certification forall clients.

We also offer to pre-review your device licenseapplication regarding compliance with therequirements of the Canadian agency TPD(Therapeutic Products Directorate).

TÜV SÜD is also authorized for the Canadianmarket as NRTL for the standard CAN/CSA-C22.2No. 601.1.

BrazilThe requirements for medical device registrationare harmonized with the other member states ofMERCOSUR. The documentation to be submitted is to a largeextent compliant with the Global HarmonizationTask Force (GHTF) Guidance for SummaryTechnical Documentation (STED). Testing andcertification by a nationally recognized certi -fication body is required for electrical medicaldevices to achieve market access in Brazil. Testsperformed by TÜV SÜD are fully recognized byBrazilian testing institutes we cooperate with.The related yearly production inspections can be performed by TÜV SÜD, e.g. within theframework of the EU Notified Body audits.

JapanThe revised Japanese Pharmaceutical AffairsLaw (PAL) became effective on 1 April 2005.There are four classes of medical devices. The quality management system conformitycriteria for manufacturing facilities of medicaldevices and in vitro diagnostic reagents areassessed prior to device approval and/or devicecertification. Not only the manufacturingfacilities in Japan, but also those overseas mustfulfill the GMP rule based upon ISO standard13485:2003. Class I products are exempt fromthe obligation of certification. Class II medicaldevices are certified by Registered Certification

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Bodies (RCB) as long as conformity certificationcriteria in form of JIS standards are assigned tothe devices. Products with a higher risk potentialstill need approval by the Pharmaceuticals andMedical Devices Agency (PMDA).

For class II devices, a product documentation in accordance with the Global HarmonizationTask Force (GHTF) Guidance for SummaryTechnical Documentation (STED) has to besubmitted to the Japanese RCB. In addition toprevious documents, detailed information on the company must also be provided.

An audit is to be carried out by the RCB inaccordance with Japanese GMP requirements(ISO 13485:2003) before device certification. For products in higher classes this responsibilityis handled by the PMDA. In this case, anassessment, but not inevitably an audit, isrequired. The extent to which GMP audits by theRCB are recognized by the PMDA for class III andIV device approval applications is not yet clear.However, manufacturers of such devices havealready been audited by TÜV SÜD to demonstratecompliance with GMP requirements to thePMDA.

TÜV SÜD has many years of experience andholds the deputy chair in the committee for theRCBs. Take advantage of our service as RCB.

The PMDA requires tests for class III and IVdevices according to JIS standards to beperformed by recognized testing laboratoriessuch as TÜV SÜD. We also offer to test yourdevices according to the national EMCrequirements.

ChinaThere are two different schemes for approval ofmedical devices in China: SFDA (State DrugAdministration of China) registration and CCC(China Compulsory Certification). The SFDAregistration covers all kinds of medical devicesmarketed in China, while the CCC is onlyrequired for seven categories of medicalappliances (1. Medical diagnostic X-rayequipment, 2. Haemodialysis equipment, 3. Hollow fiber dialyser, 4. Extra-corporeal bloodcircuit for blood purification equipment, 5. Electrocardiograph, 6. Implantable cardiacpacemaker, 7. Artificial heart-lung machine).SFDA classifies medical devices into threeclasses according to their risk potential. The registration of class II and III devicesgenerally requires testing by recognized testinglaboratories. In the case of class III devices, theSFDA performs a production inspection everyfour years. Tests carried out by TÜV SÜD arerecognized if the applicant demonstrates theaccreditation of the testing laboratory. TÜV SÜDis authorized to evaluate the application and tosubmit it to SFDA. We clarify the extent ofadditional testing for you and coordinate thetesting by a recognized national testing institute.

The existence of a CCC mark is checked bycustoms at market entrance. The CCC is handledby the China Quality Certification Center (CQC), a subsidiary of the State General Administrationfor Quality Supervision and Inspection andQuarantine of the People’s Republic of China(AQSIQ). Tests need to be carried out in China.CQC will organize the production inspection anddecides when and by whom the inspectionshould be performed. The manufacturer mayprovide a proposal for the authorizedorganization which performs the inspection, e.g. TÜV SÜD.

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TaiwanFor registration of medical devices in Taiwan, the Pharmaceutical Affairs Law (PAL) applies. The Ministry of Health handles particulardefinitions and charges official organizations withimplementation. Manufacturers wishing to exportto Taiwan must, among other things, submit adetailed company description, a description of theproduction process, and a quality systemdocumentation (QSD) including work and testinginstructions. A cooperation between the EU(including Switzerland) and Taiwanese authoritiesexists, which facilitates accelerated market accessfor medical devices. In this context, TÜV SÜDplayed a major role in the negotiations and theimplementation of a private agreement with theTaiwanese certification bodies. An audit by TÜVSÜD including the Taiwanese regulations pluscertification under ISO 13485, the audit report, anda Free Sales Certificate suffice for the GMPcompliance letter which is required for theregistration of products in Taiwan. The GMPcompliance letter from the DoH in Taiwan is validfor three years and forms one part of the records tobe submitted for any medical device registration.

As a prerequisite, the devices relevant for theTaiwanese market have to be covered at the auditunder ISO 13485. The quality management systemmust ensure that only devices registered with theTaiwanese DoH are delivered to Taiwan. There hasto be an agreement with a Taiwanese distributorregarding market surveillance and bidirectionalinformation of any complaints. Evidence regardingthe handling of vigilance and distribution has to beprovided, and is evaluated by the lead auditor foryour company. After a successful audit, we issue an audit report confirming thecompliance with Taiwanese regulations andrefering to the agreement with Taiwanesecertification bodies. This report replaces thesubmission of a QSD. Since November 2003, TÜVSÜD is authorized to perform this kind of audits.

The application for registration of the device has tobe accomplished by your representative in Taiwan,not by the foreign manufacturer. TÜV SÜD canissue a confirmation letter detailing the productswhich are covered under the scope of a valid ISO13485 certificate, usually required in the deviceregistration process.

Hong KongThe Medical Device Control Office (MDCO)regulates medical devices. On 26 November 2004,the DOH launched the Medical DeviceAdministrative Control System (MDACS) as aregulatory framework for imported medicaldevices. The proposed framework is largely in linewith the recommendations of the GlobalHarmonization Task Force (GHTF).

A Local Representative Person (LRP) is mandatory.The LRP must be either the manufacturer of thedevice or accredited by the manufacturer toperform the duties of the LRP. The LRP submits theapplication for listing medical devices and isresponsible for the marketing and post-marketprocedures which include keeping distributionrecords, handling complaints, initiating productrecalls, managing adverse incidents, and reportingchanges.

A major component of an application is theconformity assessment. The conformityassessment covers a product's qualitymanagement system, a post-market surveillancesystem, Summary Technical Documentation (STED)based on GHTF Guidance, and a Declaration ofConformity, all based on MDACS standards. Theconformity assessment will not be performed bythe MDCO, but by an independent ConformityAssessment Body (CAB).

TÜV SÜD has been recognized by the Departmentof Health as a Conformity Assessment Body (CAB)under the MDACS.

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SingaporeIn 2007, the Health Products Act was passed,allowing the Health Sciences Authority (HSA) toconduct mandatory product registration and toregulate the supply, distribution, manufacturing,import, and advertisement of health products.

There are four risk classes of medical devices in Singapore: class A, low risk; class B and C,medium risk; and class D, high risk, which are adopted from the guidance developed by the Global Harmonization Task Force. (GHTF website: www.ghtf.org).

Beginning on 1 May 2010, unlicensedmanufacturing, importation and wholesaling ofmedical devices and supply of unregistered classB, C, and D medical devices is prohibited. From 1 May 2011, the supply of unregisteredclass A medical devices is also prohibited.Documentation to be submitted needs to followthe "Common Submission Design DossierTemplate", CSDT, developed by the "AsianHarmonization Working Party", AHWP, whichclosely works together with the GHTF.

To receive the importer and wholesaler license,the organization must obtain a GDPMDS (GoodDistribution Practice for Medical Devices inSingapore) certificate by a certification body.

The organization shall establish a qualitymanagement system in accordance with therequirements of GDPMDS. If the organizationchooses to outsource any activities that mayaffect the quality of medical devices, it shallensure control over such processes.The qualitymanagement system established should besufficiently robust to meet external and internal

factors such as changes in regulatoryrequirements, customer feedback, changes tokey personnel, facilities etc.

TÜV SÜD has been accredited as a CB(Certification Body) to handle the GDPMDScertification for customers.

AustraliaThe amendment to the Therapeutic Goods Actand the new regulations took effect on 4 October2002. Australia has implemented the modeldeveloped by the GHTF. The regulations and theapproval process correspond substantially to therequirements within the EU. Nevertheless, forcompanies that do not apply the MRA betweenAustralia and the EU, a complete registrationprocess must be carried out. TÜV SÜD isauthorized within the MRA as a conformityassessment body (CAB) and offers an abbreviatedregistration process at a favorable cost.

With the AUS-EU MRA certificate we offer, theAustralien TGA incorporates devices into theAustralian Register of Therapeutic Goods (ARTG)within five working days. For this purpose, yourAustralian sponsor needs to submit the MRAcertificate, the application form, a copy oflabeling, a copy of the Australian conformitydeclaration, and a copy of the EC and ISOcertificates to the Therapeutic GoodsAdministration (TGA). Otherwise it currentlytakes between two months and one year for theTGA in case they decide to carry out an audit.Using the MRA for the registration process, thereis no audit carried out by the TGA, no additionalassessment of the technical file, no consultationwith the national health authority and thereforeno extra charges necessary.

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The following documentation is required underthe AUS-EU MRA to be reviewed prior to theissue of an AUS-EU MRA certificate:• EC and ISO certificates for the devices

concerned• last audit report issued by a certification body• test reports• product labeling (labels, user manual,

advertisement)• device description (technical drawing (only

overview), technical description)• essential requirements checklist• risk analysis summary• clinical data summary• declaration of conformity according to

Australian regulations

Our services with global impactTÜV SÜD is a National Certification Body (NCB)and, within this scope, tests medical devices in compliance with applicable IEC standards; it can issue CB reports and CB certificates. Withthese documents it is possible to acquirenational certificates and approvals offered bycertification bodies participating in the CBscheme – at present in more than 40 countries –in an abridged and therefore cost-effective andswift manner.

Further support for your export activities isavailable in the form of a Free Sales Certificatewhich is issued on request. Some non-EUcountries require such documents both as a proofof compliance with national standards andas a confirmation paper for legal sales on thedomestic market.

Is there any international body workingtowards true harmonization of approvalrequirements?Yes. The Global Harmonization Task Force (GHTF)was set up in 1993 with the aim of achievingharmonization in medical device regulatorypractices. This voluntary group has membersfrom the EU, the USA, Canada, Japan, andAustralia. The purpose of the GHTF is toencourage convergence in regulatory practicesrelated to ensuring the safety,effectiveness/performance and quality ofmedical devices, promoting technologicalinnovation, and facilitating international trade.The primary way in which the GHTF works is topublish and disseminate harmonized guidancedocuments on basic regulatory practices. Thesedocuments, which are developed by five differentGHTF study groups, can then be adopted/implemented by national regulatory authorities.TÜV SÜD also participates in various workinggroups of the GHTF.

What has the GHTF harmonized to date?There are a number of harmonized regulatorycomponents which together form the globalregulatory model. Among these components are:essential principles for safety and performance,labeling of medical devices, the role ofstandards, summary of technical documentation,classification of medical devices; and a set ofdocuments used for the vigilance reportingsystem. As quite a number of these harmonizeddocuments have been derived from the Europeanregulatory system, there is already a highcongruence between the European legislationand the global regulatory model.(www.ghtf.org).

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TÜV SÜD Product Service GmbH • Medical and Health ServicesForeign AffairsRidlerstr. 65 • 80339 Munich • GermanyPhone: +49 89 5008-4493 • E-mail: MHS-FA@tuev-sued.de • www.tuev-sued.com/mhs

www.tuev-sued.com/mhs

Your contact partner at TÜV SÜD Product Service can give you further information.

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Why TÜV SÜD?• National Certification Body able to issue

CB reports and CB certificates accepted inmore than 40 countries

• Key market approvals from one partner –saving you money!

• Prompt service – saving precious time-to-market

Regardless of whether it concerns the USA, Russia, Australia, Taiwan, or another market:Detailed knowledge of market approval routesis imperative for securing speedy and cost-effective time-to-market. TÜV SÜD experts can offer the medical device manufacturercrucial support based on long-term experienceand cooperation agreements in this field.

Profit from the experience of our long-time experienced experts to get the approvals formedical devices in the following countries:

Globalization of Medical Device Approval

RussianFederation

USA Canada Brazil Japan

China Taiwan Hong Kong Singapore Australia

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