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Medical Devices
- In-Vitro-Diagnostic (IVD)
- Processing of medical products
- Medical Devices(active/non-active)
- Active Implantable Medical Devices
- QM-System Certification
- International Approvals for Medical Products
- GM Mark

International Approvals for Medical Products

USA

The pre-market notification 510 (k) is the most common method of approving a medical or IVD device in the USA. TÜV Rheinland of North America is accredited by the U.S. Food and Drug Administration (FDA) to carry out 510 (k) reviews for most Class II devices.

Since October 2003, TÜV Rheinland of North America has also received accreditation from the FDA to carry out surveys under the Inspection by Accredited Persons (IAP) Program.

In addition to the 510 (k) process, either a type examination by a Nationally Recognized Testing Laboratory (NRTL) or an individual on site test is required for electrical medical equipment in the USA. TÜV Rheinland of North America is recognized as a NRTL in the USA and Canada. Our cTUVus mark covers electrical safety requirements for medical devices in both countries.

Canada

Effective since January 1, 2003, Canadian law requires that all manufacturers of medical and in-vitro diagnostic medical devices (IVD) in Classes II, III and IV, who wish to sell their goods on the Canadian market, need a quality management certificate in accordance with ISO 13485:1996 or ISO 13488:1996. In addition, TÜV Rheinland of North America has received accreditation to perform and issue certificates according to ISO 13485:2003 under CMDCAS which will become mandatory for all manufacturers tin Canada as of March 15, 2006.

Only certificates issued by a Canadian Medical Devices Assessment System (CMDCAS) registrar accredited by the Standards Council of Canada (SCC) will be accepted. As CMDCAS certification body for quality systems, TÜV Rheinland of North America has received accreditation to perform and issue certificates according to ISO 13485:2003. The auditors of TÜV Rheinland Product Safety are authorized to carry out audits of quality management systems under CMDCAS through TÜV Rheinland of North America.

Brazil

Electro-medical devices are covered by a mandatory certification system in Brazil. Brazil has adopted the ISO 60601 standard series as technical requirements for medical devices. TÜV Rheinland Brazil received accreditation from INMETRO (the Brazilian Authority for accreditation of system and product certification bodies). Therefore, they can issue the required certificates. Any company wishing to sell their product in Brazil needs to have a Brazilian representative appointed.

Australia/New Zealand

The Mutual Recognition Agreement (MRA) between Australia and the European Commission was signed on June 24, 1998 and came into force on January 1, 1999.

The MRA differentiates between medical devices in Classes I sterile or with measuring function, Class IIa, Class IIb and Class III. Certification of active implantable medical devices (AIMD) is also regulated within the scope of the MRA.

This agreement between the European Union and Australia allows you to carry out the conformity assessment procedure in Europe and to apply for certification in Australia afterwards. When you apply, you work with your Australian sponsor who makes the appropriate application with the Australian Register of Therapeutic Goods (ARTG). As a result, you will receive a Certificate of Conformity. The EU´s agreement with New Zealand also came into force on January 1, 1999. Due to the good economic relations between New Zealand and Australia, certification of medical devices was harmonized in New Zealand to meet the requirements of Australia. As an accredited Conformity Assessment Body (CAB), TÜV Rheinland Product Safety helps you to acquire the required Certificate of Conformity (CoC).

Japan

The Pharmaceutical Affairs Law (PAL) establishes regulations necessary for the manufacture and distribution of medical devices and pharmaceutical products in Japan. This law (PAL) was revised by the Minister of Health, Labour and Welfare (MHLW) and was effective since 1 April 2005.

Major objectives of PAL revision are:

1.Substantial revision of medical device regulation

Enhancement of various safety measures and post-marketing safety measures such as GCP, Good Quality Practices (GQP) and Good Vigilance Practices (GVP).

2. Revision of product approval system

Revision of the Approval/Licensing system from Manufacturing Approval to Marketing Authorization (Marketing Approval Holder: MAH)
Approved manufacturing and quality control of the product must comply with Japanese Good Manufacturing Practice (GMP) based on ISO 13485:2003
Foreign manufacturing establishment must operate GMP.
Foreign manufacturers must appoint a Marketing Approval Holder who has authorization to sell products in Japan.
When MAH of medical devices attempt to distribute controlled medical devices, medical devices need to be certified by a third party certification body with respect to conforming to the conformity certification.
Accreditation of Third Party Certification Bodies by MHLW.

TÜV Rheinland Japan has applied to MHLW for accreditation of third party certification body under the new Japanese regulation of medical devices. TÜV Rheinland Japan provides certification service of control medical device and assessment of conformity for the quality assurance requirements (GMP).

China

On October 1, 1997, China introduced compulsory registration for certain medical devices and extended it in April 2000. It affects all devices used in physicians practices and hospitals and serves either medical diagnosis, observation or treatment.

The SFDA (State Food And Drug Administration) is responsible for registration. It specifies a division of the medical devices into three classes which different standards are applied.

Class I:

The Declaration of Conformity, the technical standard for product, the instruction for use and other relevant information should be submitted.

Class II:

Class III:

Besides the technical standard for product, the instruction for use and other relevant information which should be submitted, a CE certificate from Notified Body (e.g. TÜV Rheinland Product Safety GmbH) must be submitted and clinical tests and examination of the quality management system are required. Moreover, the China Quality Certification Center (CQC) monitors the safety tests on devices to be imported.

We can take over the entire approval operation (incl. translation of the documents into Chinese) as well as the negotiations and meetings with the Chinese authorities and institutions for you.

Taiwan

TÜV Rheinland Product Safety is a designated Notified Body Partner in the Technical Cooperation Program between EU AIMD/MDD/ IVDD Notified Body Partners and DOH Designated Auditing Organizations (TCP). DOH is the abbreviation for the Department of Health of Taiwan. Before this program was coming into force, an European manufacturer had two choices of applicable modules to register Medical Devices in Taiwan:

Module QSD: the European manufacturer needs to submit Quality System Documentation (QSD) which includes the quality manual, general SOP´s to show compliance with GMP requirements, list of quality system documents, production flow chart, facility list, layout of production area and the ISO 13485/EN 46001 certificate.
Module Onsite Inspection: the European manufacturing facility needs to be audited by the DOH Designated Auditing Organizations and QSD need to be reviewed.

Within the TCP program, EN ISO 13485 certificates of designated Notified Body Partners such as TÜV Rheinland Product Safety are acknowledged by the Taiwanese DOH. The EN ISO 13485 certificate and a cover letter are both issued by TÜV Rheinland Product Safety. Together with the recent audit report and a Taiwanese application form, they are ready for the registration of medical devices in Taiwan. The TCP program was approved by the DOH Medical Device GMP Committee on September 15, 2004.

Russia

For the certification of active medical devices to be exported to the Russian Federation, the safety and innocuousness of medical devices in accordance with the relevant Russian GOST standards must be guaranteed. These tests have to be carried out by a testing body accredited by the GOST R system. The test of conformity with Russian safety requirements should also meet the Essential requirements of the EC medical devices directive 93/42/EEC. Additional documents are required for certification (e.g.brochures, product description, instructions for use and risk analysis).

In addition to the GOST R certificate, the sale of medical devices in Russia demands a registration certification from the Department for the Certification and Registration of New Medical Technology of the Ministry of Health of the Russian Federation.

We help you with the GOST R certification procedure and registration for the Ministry of Health.