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. Revision of the EU Medical Device Regulations
2. New MDCG Guidance for MDR
3. Europa Document References – MEDDEV’s
4. NB-MED Documents
5. OEIL – Legislative Observatory
6. European Association of Authorized Representatives (EAAR)
7. Competent Authority Contact Points
8. Notified Body Operations Group (NBOG) Documents

 

 

US Regulatory Requirements

1. FDA 21 CFR Database Search Tool
2. FDA Guidance Document Search Tool
3. CDRH Databases
4. Registration & Listing Database for Medical Devices

 Canadian Regulatory Requirements

1. Canadian License Searches
2. Canadian Medical Device License Application Fees
3. GD210 from Health Canada
4. How to search for the Canadian MDR
5. List of Recognized Registrars

Global Regulatory Resources

1. International Medical Device Regulators Forum (IMDRF) – “The New GHTF”
2. How to find guidance documents from GHTF study groups…look for the final documents rather than drafts.
3. ICH Guidance Documents

Recommended Vendors

1. Estonian Standards
2. AAMI American Standards
3. Eurofins Medical Device Testing USA
4. Eisner Safety “the 60601 guy”