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International Approvals for Medical Products
Capture new markets in the world as a manufacturer of medical devices
USA
The pre-market notification 510 (k) is the most common method of approving a medical or IVD device in the USA. TUV Rheinland of North America, Inc. 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, TUV Rheinland of North America, Inc. has also received accreditation from the FDA to carry out surveys under the Inspection by Accredited Persons (IAP) Program. Take advantage of our experience and our local presence if you want a quick and trouble-free market launch.
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. TUV Rheinland of North America, Inc. is recognised 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, TUV Rheinland of North America, Inc. has received accreditation to perform and issue certificates according to ISO 13485:2003 under CMDCAS, which will become mandatory for all manufacturers selling devices into 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. TUV Rheinland of North America, Inc. as CMDCAS certification body for quality systems has this accreditation. The auditors of TÜV Rheinland Product Safety GmbH are authorized to carry out audits of quality management systems under CMDCAS on the order of TUV Rheinland of North America, Inc.
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 Brasil received accreditation from INMETRO (the Brazilian Authority for accreditation of system and product certification bodies) and can therefore issue the required certificates. Any company wishing to sell their product in Brazil need to have a Brazilian representative appointed who can act on their behalf on all matters related to the product sold in Brazil. For more informations concerning Brazilian Approval, please contact the TÜV Rheinland office near you or directly TÜV Rheinland Brasil.
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 applying, you work hand in hand with your Australian sponsor who makes the appropriate application with the Australian Register of Therapeutic Goods, ARTG and hands in your Certificate of Conformity. The EU´s agreement with New Zealand likewise came into force on January 1, 1999. Due to the good economic relations between New Zealand and Australia, there was a harmonization of the certification of medical devices in New Zealand so as to meet the requirements of Australia. As an accredited Conformity Assessment Body (CAB), TÜV Rheinland Product Safety GmbH helps you to acquire the required Certificate of Conformity (CoC).
Taiwan
TÜV Rheinland Product Safety GmbH is a designated Notified Body Partner in the Technical Cooperation Programme 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 programme was coming into force an European manufacturer had the choice of two applicable modules to register Medical Devices in Taiwan:
- Module QSD: the European manufacturer needs to submit Quality System Documentation (QSD), which includs 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 need to be audited by the DOH Designated Auditing Organizations and QSD need to be reviewed.
Within the TCP programme EN ISO 13485 certificates of designated Notified Body Partners, such as TÜV Rheinland Product Safety GmbH, are acknowledged by the Taiwanese DOH. The EN ISO 13485 certificate and a cover letter, both issued by TÜV Rheinland Product Safety GmbH, together with the recent audit report and a Taiwanese application form is sufficient for the registration of medical devices in Taiwan. The TCP programme was approved by the DOH Medical Device GMP Committee on September 15, 2004
Russia
For the certification of active medical devices for export to the Russian Federation, proof must be furnished that the safety and innocuousness of medical devices in accordance with the relevant Russian GOST standards are guaranteed. These tests have to be carried out by a testing body accredited by the GOST R system. Further basis of the test of conformity with Russian safety requirements is the fulfilment of the Essential requirements of the EC medical devices directive 93/42/EEC, which are laid down in harmonized and national standards.Additional documents are also required for certification (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 can help you with the GOST R certification procedure and with registration at the Ministry of Health.
Contact us - we are looking forward to hearing from you!
