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International Approval for Medical Devices

International Approval for Medical Devices

Your Gateway to New Markets

At TÜV Rheinland, we can help you get approval for your medical devices around the world, especially in Japan, Taiwan, China, USA, Canada, Australia, Brazil, and Russia. Choose our one-stop service - with local contacts, all highly familiar with the terms of approval in each country. Take advantage of our experience for your gateway to new markets. Our staff can tell you which registration process is right for your product.

Benefits at a Glance

With the support of TÜV Rheinland for approval of your medical devices, you:

  • Rely on one-stop-shop service from a single source.
  • Save time and money when you combine conformity assessment procedures with audits.
  • Benefit from quick turnaround times and our long-standing experience and expertise.
  • Have skilled contacts on site - always up-to-date on the latest developments.

Japan

In Japan, our experts can help with approvals of medium-risk medical devices, so-called "designated controlled medical devices." Designated controlled medical devices include Class II listed medical devices and in-vitro diagnostic medical devices. In addition to product testing, we also carry out audits for compliance with Japanese GMP requirements. Your benefit, if you also want to apply for approval of high-risk class III/IV products with the PMDA, the Pharmaceutical and Medical Devices Agency.

Taiwan

The easiest way to approval in Taiwan is via the Technical Cooperation Program. As part of this program, during a regular audit of your quality management system for compliance with EN ISO 13485, TÜV Rheinland can check if your company meets Taiwanese GMP requirements. A positive audit report from us and the EN ISO 13485 certificate issued by us are required to apply for the "GMP compliance letter" required for approval of medical devices in Taiwan.

China

Equipment and materials used in doctors' offices or hospitals and for medical diagnosis, monitoring or treatment, are subject to state registration with the Chinese State Food and Drug Administration, SFDA. We can offer full service, right from initial submission:

  • Review of registration obligations, classification
  • Development of product standards
  • Compilation of documents and translation into Chinese
  • Support of product testing
  • Formal application to SFDA and coordination of communication between your company, the SFDA, and the testing laboratory
  • We take care of the testing for the so-called "China Compulsory Certification," CCC for short. This additional testing is required for individual medical devices, such as X-ray machines or pacemakers, and is done at the same time as the registration process
  • Support from our local employees in negotiations and meetings with Chinese authorities and institutions

USA

Class II and III Medical Devices
For manufacturers of class II and III medical devices, the US-EU Mutual Recognition Agreement and U.S. law on "Medical Device User Fee and Modernization Act" are both of interest. Both allow inspections by accredited institutions, so-called third parties for MRA and Accredited Persons. We are accredited for both programs and can carry out FDA inspections in combination with audits based on other regulatory requirements.

Type Approval Testing
Electrical medical equipment in the United States either requires type approval testing by an NRTL, a Nationally Recognized Testing Laboratory, or individual approval on site. With our cTUVus mark, you meet the requirements for electrical safety of medical devices in the U.S. and Canada.

Canada

In Canada, a Quality Management System compliant with ISO 13485 CMDCAS is required for approvals of class II, III, and IV medical and in-vitro diagnostic devices. As an officially recognized CMDCAS registrar, we can manage certification of your quality management system.

Australia and New Zealand

Our experts would be happy to help you with your approval processes in Australia and New Zealand. The admission requirement is a Certificate of Conformity, CoC for short. Due to mutual contractual agreements, you can manage the required conformity assessment procedures in Europe. You then apply for authorization in the country you need.

Brazil

In Brazil, your medical devices need so-called "ANVISA product registrations." In addition, a mandatory certification system applies for electrical and medical devices, for which Brazil has adopted the series of standards of IEC 60601 as technical requirements. As an accredited body, we can issue the necessary permits for you.

TÜV Rheinland Brazil is accredited by INMETRO, the Brazilian accreditation body for system and product certification centers and can therefore issue the necessary permits.

Russia

As an accredited agency, we can support approval of your active medical devices for the GOST R certification process and upon registration of products with the Ministry of Health.

Our Worldwide Accreditations

Japan
Authorization as an RCB, Registered Certification Body, for medical devices with medium risk

Taiwan
Authorization as a partner of the DOH, Department of Health, as part of the "Technical Cooperation Program," TCP for short

USA

  • Accredited by the U.S. Food and Drug Administration
  • Approval for inspections in accordance with the US-EU Mutual Recognition Agreement, MRA for short, and the "Medical Device User Fee and Modernization Act"
  • Recognized as a Nationally Recognized Testing Laboratory, NRTL, in the U.S. and Canada

Canada
Admission as an official Canadian Medical Devices Conformity Assessment System Registrar, CMDCAS for short, with the Standards Council of Canada for certifying quality management systems in accordance with ISO 13485

Australia and New Zealand
Accredited Conformity Assessment Body, CAB, for approval of medical devices

Russia
GOST R accredited certification body and as a GOST R laboratory

Brazil
Accredited with INMETRO, the authority for system and product certification bodies

MDSAP: Common Quality Management Standard for Australia, Brazil, Canada, the US, and Japan

The pilot phase of the MDSAP (Medical Device Single Audit Program) runs through the end of 2016, and the program will soon officially launch in January 2017. This program will create a common standard for quality management audits of medical device manufacturers in five countries. The participating countries are Australia (TGA), Brazil (ANVISA), Canada* (Health Canada), the US (FDA), and Japan (Ministry of Health, Labor, and Welfare).

With the launch of this program the related competent authorities are opening the certification of quality management systems up to external service providers. Up until now, typically the competent authorities have been responsible for product and quality management assessment. As an MDSAP-authorized audit organization, TÜV Rheinland is eligible to audit the quality management system of a medical device manufacturer in the specified markets.

* After the pilot phase, Health Canada intends to officially use MDSAP as the standard for quality management conformity assessment. MDSAP would thus replace the Canadian Medical Devices Conformity Assessment System (CMDCAS).

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pdf Questionnaire for the preparation of an offer for medical products 181 KB Download
pdf General Terms & Conditions 62 KB Download
pdf Testing & Certification Regulations 120 KB Download

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