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Medical Device Market Approval & Certification

Decipher global market requirements

The medical device market is governed by different national and international standards and regulations., which companiesmust fulfill. Our dedicated Foreign Affairs Department ensures you do just that.

We accompany you through the complex medical device regulatory requirements for your product's target markets.

Our comprehensive international accreditations and membership in the CB scheme facilitates your worldwide product and system certification with maximum efficiency.

Your Market Approval and Medical Device Certification partner for:

Market Approval and Certification

 Services

Europe –
CE marking

TÜV SÜD is a Notified Body (ID number 0123) for European Directives, a mandatory requirement for all products entering the EU. Our services include quality management system auditing, design dossier review, product testing and verification according to the required 93/42/EEC (MDD), 90/385/EEC (AIMD) and 98/79/EC (IVDD) directives.

US –
FDA 510(k)

TÜV SÜD is an FDA-accredited body for FDA 510(k) third-party review, a programme for medical device market clearance into the US. We support manufacturers in places worldwide through the FDA Accredited Persons 510(k) Third-Party Review Programme, created by the FDA to improve efficiency and timeliness of the FDA 510(k) process. Other services include FDA third-party inspections and mock inspections.

Canada – CMDCAS

Manufacturers selling class II, III and IV medical devices and IVD devices in Canada must have a quality management system certified according to ISO 13485 by a Canadian Medical Device Conformity Assessment System (CMDCAS) recognised registrar in order to obtain the license to sell their devices in Canada.

  • TÜV SÜD was the first registrar accredited by the Standards Council of Canada (SCC) to perform ISO 13485 CMDCAS certification. This can be performed in parallel to ISO 13485 audits.
  • TÜV SÜD is a National Recognised Testing Laboratory (NRTL) for CSA C22.2. 60601-1.

Japan –
PAL & JGMP

Manufacturers from regions outside of Japan are required to obtain a license for marketing authorisation before they can sell pharmaceutical products manufactured in other countries. TÜV SÜD certification helps your products qualify for market entry into Japan by fulfilling PAL regulation.

Japanese Pharmaceutical Affairs Law (PAL) regulates medical devices, IVD reagents, medicines, quasi drugs and cosmetics in the Japanese market. The revised PAL became effective on 1 April 2005. It has four classes of medical devices and allows registered third-party certification bodies to assess and certify class II devices with conformity certification criteria (MHLW notice No. 112 issued on 2005-03-25). For in-vitro diagnostic reagents, all those classified as class II can be assessed and certified by registered third parties. TÜV SÜD is the first certification body registered by the Ministry of Health Labour and Welfare in Japan. TÜV SÜD is also a Recognised Certification Body (RCB) for all designated controlled medical devices and in-vitro diagnostic reagents.

TÜV SÜD is authorised to perform JGMP (Japan Good Manufacturing Practice) audits, which are part of conditions to obtain a marketing approval certificate at manufacturing facilities worldwide. We also provide product safety and EMC testing for active medical devices according to Japanese Industrial Standards (JIS).

Australia – MRA

TÜV SÜD is accredited as a Conformity Assessment Body (CAB) within the Agreement on Mutual Recognition Agreement (MRA) in relation to conformity assessment, certificates and markings between the European Community and Australia – Sectoral Annex on medical devices.

Based on this agreement, TÜV SÜD is authorised to issue a Certificate of Conformity which can be used by European manufacturers in order to apply for product registration at TGA (Therapeutic Goods Administration) without further assessment.

Russia – Declaration of Conformity

TÜV SÜD can carry out the complete approval process from registration to issuance of declaration of conformity.

The well-known GOST-R certification process has been cancelled for most medical devices. It has been replaced by the declaration of conformity that is a separate procedure and starts after registration of the medical device has been completed.

China –
SFDA & CCC

Registration of class II and III medical devices requires testing by recognised test laboratories. TÜV SÜD has awarded CARAT (Certified after Recognition of Agent’s Testing) recognition to the four largest medical test laboratories in China.

  • Devices can be tested according to requirements of multiple markets in one laboratory, facilitating your market approval process.
  • Tests done by TÜV SÜD are partly recognised, according to prior agreement, by the Chinese test centres.
  • Our services also extend to evaluation and submission of applications to the State Food and Drug Administration (SFDA), the authority responsible for medical device regulations.
  • Certain medical devices are also regulated by the China Quality Certification Centre (CQC). These are required to obtain the CCC Mark before being placed on the market.

Singapore – Health Products Act & GDPMDS

Medical products for import, distribution and sale  in Singapore have to meet the requirements of the Health Products Act 2007.

To receive the importer and wholesaler license, each organization must obtain a GDPMDS (Good Distribution Practice for Medical Devices in Singapore) certificate by a Certification Body (CB). For this, the organizations shall establish a quality management system in accordance with the requirements of GDPMDS.

TÜV SÜD has been accredited as a CB and thus can handle the GDPMDS certification for its clients.

Korea –
Korea Food and Drug Administration

TÜV SÜD has the experience and capability to assess manufacturers’ products regarding the compliance with Korean requirements and obtaining the necessary approvals.

  • Medical devices must be approved for sale in their country-of-manufacturer before placing on the market.
  • All medical devices manufacturers must meet Korean Good Manufacturing Practice (KGMP).
  • Pre-market notification for Class I products and pre-market approval for Class II, III and IV devices are required.
  • TÜV SÜD Korea is authorised by the Korea Food and Drug Administration (KFDA) to perform Technical File Review on Class II medical devices.

Brazil – ANVISA Registration

Medical device manufacturers must apply for product registration at ANVISA (Agência Nacional de Vigilância Sanitária) which is the national health survilance agency. Manufacturers without a subsidiary in Brazil which intend to place medical devices on the market there must obtain representation by a Brazilian Registration Holder (BRH) recognized by ANVISA. The BRH is responsible for all communication and registration activities with ANVISA.

For medical devices falling under the scope of IEC 60601-1 and also for some other non-active medical devices, INMETRO certification is a prerequisite in order to obtain ANVISA registration. TÜV SÜD can carry out the annual factory inspection which is required in order to achieve INMETRO certification

Taiwan

Manufacturers wishing to export to Taiwan must, among other things, submit a detailed company description, a description of the production process, and a quality system documentation (QSD) including work and testing instructions.

A technical cooperation programme between the EU (including Switzerland) and Taiwanese authorities exists, which facilitates accelerated market access for medical devices. In this context, TÜV SÜD played a major role in the negotiations and the implementation of the technical cooperation programme with the Taiwanese certification bodies. An audit by TÜV SÜD including the Taiwanese regulations plus certification under ISO 13485, the audit report, and a Free Sales Certificate suffice for the GMP compliance letter which is required for the registration of products in Taiwan.

 

Your benefits at a glance

 
  • Improve your process quality and transparency
  • Ensure quality, safety and performance of your devices
  • Raise brand reputation and consumer trust and satisfaction
  • Avoid costly product recalls by delivering consistent quality and safety