World Health Organization
This document is intended to provide guidance and support to WHO Member States that have yet to develop and implement regulatory controls relating to medical devices, as well as jurisdictions that are continuing to improve their regulatory frameworks as they take steps to ensure the quality and safety of medical devices available in their countries.
The final version of the draft “Good regulatory practices”: guidelines for national regulatory authorities for medical products that were used as a reference in the Standards Alliance 1.0.
International Medical Device Regulators Forum
IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.
Optimizing Standards for Regulatory Use.
Asia Harmonization Working Party
The information provided in this playbook is primarily based on the Global Harmonization Task Force (GHTF) guidance documents and approach. The playbook is intended to guide regulators in the understanding and implementation of an efficient and cost-effective medical devices regulatory system.
FDA Medical Device Program Reference Documents
- Standards and Conformity Assessment Program
- CDRH Learn
Inspections – Global Harmonization
- Primer – International Medical Device Regulators Forum (IMDRF) – Medical Device Single Audit Program (MDSAP) Pilot [Presentation] [Printable Slides] [Transcript]
- Introduction to MDSAP [Presentation]
- MDSAP Management [Presentation]
- MDSAP Device Marketing Authorization and Facility Registration [ Presentation]
- MDSAP Measurement, Analysis and Improvement [Presentation]
- MDSAP Medical Device Adverse Events and Advisory Notices Reporting [ Presentation]
- MDSAP Design and Development [ Presentation]
- MDSAP Production and Service Controls, part 1 [Presentation]
- MDSAP Production and Service Controls, part 2 [Presentation]
- MDSAP Production and Service Controls, part 3 [Presentation]
- MDSAP Purchasing [Presentation]
Recommended GRP Implementation Policy for Medical Device Regulatory Agencies
- Agency documentation of WHO, OECD, WTO implementation
- Agency search for relevant international standards as a pre-step to drafting regulation
- Agency use of relevant international standards
- Agency participation in (international) standardization
- Agency Regulatory Impact Assessment
- Agency ex-post review
- Agency publication of standards use
- Agency designated of position responsible for implementation of the above
- Global Health and Medical Device References
- Good Regulatory Practice References
- Trade and Regulatory References
- WTO Technical Barriers to Trade [English], [Spanish]
- WTO TBT Agreement Text [English], [Spanish]
- Supporting the TBT Agreement with Good Regulatory Practices Implementation Options for APEC Members
- International Standardization, GRP and Regulator Use of Standards References
- Industry Regulatory References
- Americas Business Dialogue (ABD)
- Americas Business Dialogue – 2018 Report “Action for Growth” [English], [Spanish]
- Recommendation #3 – Implement mechanisms to ensure legitimate, transparent and technically sound regulations, and adopt administrative simplification plans
- Recommendation #7 – Develop a mechanism for private sector and inter-government coordination on regulatory cooperation projects that helps economies implement a shared set of Good Regulatory Practices (GRPs), to develop competitive economies and support participatory and transparent democracies.
- U.S. Chamber of Commerce – Center for Global Regulatory Cooperation
- Medical Device Industry References