WHO Regulatory Approach for Medical Devices

The WHO has been working on a schedule for the Global Model Regulatory Framework for Medical Devices including In-Vitro Diagnostic devices (IVDs).


June 06, 2016: The framework would definitely help the global medical devices industry to improve quality of medical devices and solutions, weed out substandard devices and promote transparency. The following is the schedule for reference:


The World Health Assembly 2014 has Resolution 67.20 on regulatory system strengthening for medical products. The resolution focuses on the need for regulating medical devices and had requested the Director General :


(4) to prioristise support for establishing and strengthening regional and sub-regional areas of regulation of health products that are least developed such as regulation of medical devices including diagnostics





24 May 2014

WHO came up with the decision to develop a model for regulating medical devices


April 2015

A Working Group was formed for the development of a model regulation for medical devices (Working Group) consisting of professionals in regulating medical devices


June 2015

First telephonic conference was held with the Working Group. Approval was given by the Working Group for the development of a model regulation for medical devices (Working Group), consisting of professionals in regulating medical devices


July 2015

First face to face meeting of the Working Group which agreed on the following:

Table of contents of the Model Regulatory Framework (Model)

Definition of medical device, definition of in vitro medical device (IVD)

Risk classes of medical devices; life cycle;

Stepwise approach of three steps;

Good regulatory practices for effective implementation; number of specific topics;

29-30 September 2015

A discussion on the model of the regulatory approach was added to the agenda of the meeting for the 50th Expert Committee for the Specifications of Pharmaceutical Preparations (ECSPP)


12 October 2015


Meeting of Expert Committee for Biological Standardization (ECBS). ECBS agreed to receive the Model for information.


12 October 2015

First draft of the model developed by a drafting group consisting of three Working Group members with inputs from the full Working Group


5-10 December 2015

Circulation of the Draft of the Model to the Working Group and WHO staff members for comments and feedback


December 2015–January 2016

Feedback Compilation

January 2016

Second Face to Face Meeting of the Working Group. Following conclusions were arrived at:

Draft needs to be simplified and made easier to read.

Scope of the draft needs to be refined, title changed and chapters merged

Stepwise approach changed to two steps model.


9-10 February 2016

Compilation of comments from the Face to Face meeting of the Working Group


February-March 2016

Development of a revised Model on the basis of inputs from Working Group members


21-26 March 2016

Circulation of revised version of the Model for feedback and comments from Working Group members and WHO staff


Mid-April 2016

Compilation of comments of Working Group


End April 2016

Public Consultation


May-Mid June 2016

Compilation of all comments received


Mid June to end June 2016

Teleconference with Working Group for discussion on comments received


Early July 2016

Second Public Consultation


July to Mid August 2016

Teleconference with Working Group to discuss the comments received


End August 2016

Submitting the draft of WHO Global Regulatory Model for Medical Devices including IVDs to ECSPP and ECBS


September 2016

Presentation of the Model to the 51st ECSPP meeting for endorsement


17-21 October 2016

Follow up Action if any needed




For complete details please refer to http://www.who.int/medicines/areas/quality_safety/quality_assurance/ModelregulatoryFramework-MedDev-QAS16-664.pdf


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