Regulatory Links

Regulatory Links were found to be accurate on Jan 2022. If you find a broken Link or have suggestions for new Link, let us know.

Regulatory Organizations

Global Harmonization Task Force

US FDA

• Center for Devices and Radiological Health

• Industry Support

• Overview of FDA Regulations

• Recognized Consensus Standards

OSHA regulations and NRTL program

Health Canada

• Therapeutic Product Directorate

• Recognized Standards for Medical Devices

European Medical Device Regulations& Directives, (europa.eu, medical device sector)

• MDD Harmonized Standards and for Other Directives, (europa.eu), in transition, legal market access now, no longer valid after 26 May 2025

• MDR Harmonized Standards, in transition, legal market access from 26 May 2021, only legal option after valid from 26 May 2021,

• MedDev Guidance

• NB-Med Guidance

• UK Medicines and Healthcare products Regulatory Agency, (MHRA, formerly MDA)

• Machinery Directive (MD) and MD Harmonized Standards

Japan Ministry of Health, Labour, and Welfare (MHW)

Medical Device Adverse Incident Databases

While accessing device risk, or while determining the appropriateness of existing safety requirements, it can be useful to consider adverse incidents for similar products. The following links can be used to review reported adverse incidents.

US FDA - Manufacturer and User Facility Device Experience (MAUDE) Database

UK - MHRA Adverse Incident Reports

EUDAMED - European Database on Medical Devices (21 Jan 2022, doesn't appear to be searchable?)