E-DRUG: WHO Model Regulatory Framework for medical devices incl IVDs
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Dear e-druggers,
WHO initiated the development of the WHO Global Model Regulatory Framework
for Medical Devices including IVDs (the Model) to support its Member States
in ensuring the quality and safety of medical devices.
Based on Resolution WHA 67.20 Regulatory Systems Strengthening for Medical
Products adopted by the World Health Assembly in 2014, WHO has undertaken a
series of activities to scale up and strengthen regulatory capacities
worldwide.
The development of the Model represents such an activity for medical
devices.
The Model presents a two-step approach to regulate the quality and safety of
medical devices. The first is a basic level including the establishment of a
regulatory framework and controls to gain market oversight and a system for
reporting serious adverse events. Building on the basic level controls,
expanded level controls are intended to address other stages in the medical
device life cycle and to exert more comprehensive controls. In adopting
expanded level regulation, the regulatory authority may choose to implement
regulatory controls according to national priorities.
The draft of the Model is now open for public consultation. We cordially
invite you to provide comments. Please follow the link
http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects
/en/ for the text of the Model, the form to insert your comments and the
timetable for the development of the Model.
If you have any further questions, do not hesitate to send me an email.
Yours sincerely,
Josée Hansen
Senior Advisor
Department of Essential Medicines and Health Products
World Health Organization
20 Avenue Appia
1211 Geneva 27, Switzerland
Email hansenj@who.int
Telephone: +41 22 791 5578