Regulatory Requirements for Europe, USA, Canada and Globally

Keeping track of all the global regulatory requirements on your computer desktop is nearly impossible, but you don’t have to. Medical Device Academy’s consulting team saved the links to the most common regulatory resources for regulatory submissions and compliance. The links should be up-to-date, because we use this page ourselves. However, please don’t hesitate to let us know if you find a broken link or if you want us to add the links for another country. Just let us know which regulatory requirements you’re looking for on our suggestion box page.

EU Regulatory Requirements

1. Draft Revision of the EU Medical Device Regulations

2. Current Legislation in the EU

3. Europa Document References – MEDDEV’s

4. NB-MED Documents

5. OEIL – Legislative Observatory

6. European Association of Authorized Representatives (EAAR)

8. Competent Authority Contact Points

9. Notified Body Operations Group (NBOG)

10. Central Management Committe (CMC) on Medical Devices

 

international harmonization1 300x293 Regulatory Requirements for Europe, USA, Canada and Globally 

 

Note: GHTF website is no longer active. There is now a link to the IMDRF website where the documents are now housed.

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