World Health Organization

WHO Global Model Regulatory Framework for Medical Devices including IVD Medical Devices

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.

Good Regulatory Practices in the Regulation of Medical Products

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.

IMDRF/Standards WG/N51 FINAL:2018

Optimizing Standards for Regulatory Use.

Asia Harmonization Working Party

Playbook for Implementation of a Medical Device Regulatory Framework

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

Inspections – Global Harmonization

Medical Device Single Audit Program (MDSAP)

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

Additional Information