Links to regulations for Medical Devices worldwide
 Market |
Information on Regulation |
Related TÜV SÜD Service |
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| EUROPE | http://europa.eu.int/comm/enterprise/ medical_devices/index.htm (This page refers to the European directives, Implementing legislation, standards, Guidance's, National and Competent Authorities and more). |
TÜV
SÜD Product Service GmbH is Notified Body for
Medical Devices. TÜV SÜD Japan offers related auditing and testing service. |
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| USA | http://www.fda.gov/ The homepage of the FDA provides information on all FDA regulated devices. For Medical devices you will find information concerning regulatory requirements, adverse event reporting etc. |
TÜV SÜD Japan organizes 510k Review by TÜV SÜD America Inc. an accredited 510k Third Party Reviewer. | ||||||||||||
| CANADA | http://laws.justice.gc.ca/en/F-27/ SOR-98-282/index.html (Canadian Medical Device Regulations). http://www.hc-sc.gc.ca/ (The homepage of Health Canada helps you to find specific information and contact addresses). |
TÜV SÜD Japan performs ISO 13485 audits for the Health Canada Recognized Registrar TÜV SÜD America Inc. | ||||||||||||
| AUSTRALIA | http://www.tga.gov.au/index.htm (The homepage of the TGA summarizes all medical device regulation for Australia) |
TÜV
SÜD PS Notified Body certificates are generaly
accepted by the TGA for manufactures outside Australia. |
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| JAPAN |
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TÜV
SÜD JAPAN is Registered Certification Body with
the registration number "AA". We can certify class II medical devices with conformity criteria, and all the class II in vitro diagnostic reagents under the new Pharmaceutical Affairs Law (PAL). |
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| GHTF | http://www.ghtf.org/ Global Harmonisation Task Force |
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Information on ISO 13485 Transition periods:
End Of Transition Period |
Source |
|
| ISO Version | July 15th, 2006 | Normal transition period of three years after publication |
| EN ISO Version | July 31th, 2006 | http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/ c_083/c_08320040402en00070007.pdf |
| Canada | March 15th, 2006 | http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ transition_iso_13485-2003 _notice_october_2003_e.html |