1. World Health Organization
WHO Global Regulatory Model Framework for medical devices including IVDs medical devices
PAHO MEETING – OTTAWA , CANADA
2017

2. WHO Mandate
In May 2007, the first resolution on health technologies was adopted by the World Health Assembly (WHA) (WHA ), which set the framework for an unprecedented focus on health technologies, but more specifically on medical devices.
In 2014, the WHA adopted a resolution regarding regulatory system strengthening for medical products (WHA 67.20)…including strengthening areas of regulation of health products that are the least developed, such as regulation of medical devices, including diagnostics;

4. WHO Mandate....
In the context of Resolution and because there was growing interest in medical devices in the global health community and a lack of regulatory systems for medical devices in many countries, WHO decided to develop the MODEL.
It intends to provide guidance and support to WHO Member States that are 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 quality and safety of medical devices in their countries.

5. Regulation of medical devices: global

7. WHO Model Regulatory Framework
World Health Organization
WHO Model Regulatory Framework
5 June, 2018
A WHO Model Regulatory Framework for medical devices including IVD’s with global input and reflecting a modular approach in regulating medical devices
How to begin regulating?
What to regulate: harmonized definitions and guiding principles
How to regulate: stepwise development and implementation
When to regulate: priorities and transitional period
(Given the preliminary results, it is evident that the regulation of medical devices is lagging behind compared to other products. A number of countries have expressed a need for guidance on how to plan and implement a regulatory framework for medical devices.)

8. Recent publications

9. Earlier publications
2001
2003
2011

10. Common approach for regulating medical devices
Need to regulate medical devices and create market oversight
Definition, risk classes, essential principles of quality and performance
Stepwise approach: two or three steps
Convergence, harmonization, collaboration

11. Regulating medical devices - challenges
Less developed regulatory systems than for vaccines and medicines
Lack of awareness
Regulating in an existing market
Lack of specialized knowledge and resources to draft and implement medical devices regulations
Lack of resources

12. World Health Organization
Target audience
5 June, 2018
Countries with no or limited regulatory framework in place
With the ambition to improve this situation
The legislative, executive and regulatory branches of government

13. Introducing the Model
Organized into 5 chapters, acronyms, abbreviations, acknowledgement ,references and 2 appendixes.
5 Chapters are:
Introduction
Definition, classification, essential principles and conformity assessment of medical devices.
Enabling conditions for effective regulation of medical devices.

14. Introducing the Model………
Enabling conditions:
Legal requirements
Gap analysis of existing controls (elements to be considered have been provided in the model)
Implementation plan
Monitoring implementation
Regulatory authority with enforcement power
Funding the regulatory system (resources = activities mandated in the Law
Conflict of interest and impartiality and Regulatory competencies and resources

15. Introducing the model…….
Establishing a stepwise approach to regulating medical devices and reliance.
Additional topics such as Disposal, Donation, reprocessing, refurbishing, substandard & falsified products, WHO PQ team ….etc

16. World Health Organization
Two steps approach
5 June, 2018
Basic level controls and enforcement
Legal framework
Market oversight
Reporting system
Expanded level controls and enforcement
regulatory controls depending on the priorities of the country

19. Convergence and harmonization
World Health Organization
Convergence and harmonization
5 June, 2018
Convergence and harmonization
Definition of a medical device
Classification of medical devices
Essential principles of safety and performance
QMS
Standards
Confidence building and Information sharing
Reliance and recognition
The following table shows controls for medical devices showing elements for which regulatory guidance has been developed and those that may be implemented through reliance or recognition. The elements indicated in RED are those for which international regulatory harmonization guidance documents have been developed. Elements that may be implemented through reliance or recognition are indicated in BLUE

21. The Model Regulatory Framework for medical devices does not cover:
World Health Organization
The Model Regulatory Framework for medical devices does not cover:
5 June, 2018
Establishing a single nomenclature system
Norms and standards for medical devices
Guidance on combination products
Financing of the regulatory system for medical devices
The model will not establish a nomenclature system, although we are going to say what the future nomenclature would require especially in relation to the UDI.
We will not develop norms and standards, but we will speak about a number of norms that can be considered as core norms when regulating medical devices and we will describe the need for a process to recognize standards.
Guidance on combination products we will cover to a limited extent. It is a huge area when you speak about combination products and the borderline products between medicines, medical devices, cosmetics.
The way to finance the system to regulate medical devices is very much country dependant. We think we can not describe a meaningful model there.

22. World Health Organization
5 June, 2018
Working Group Members (Non-WHO Staff)
Mr. Abdullah S. AL-Dobaib
Executive Director of Registration and Licensing, Saudi Food and Drug Authority
Tuncay Bayrak
Assistant Health Expert, Republic of Turkey Ministry of Health
Michael Gropp
Alan Kent
Consultant
Agnes Kijo
Manager, Medical Devices and Diagnostics Registration, Tanzania Food and Drugs Authority (TFDA)
Niall MacAleenan
Medical Device Lead/Clinical Asessment and Policy Manager, Health Products Regulatory Authority, Ireland
Nancy Shadeed
Special Advisor, Health Canada
Maura Linda Sitanggang/ Lupi Trilaksono
Director General of Pharmaceutical Services and Medical Devices, National Agency of Drug and Food Control, Indonesia
Shelley Tang
Stellar Consulting
Kim Trautman
Associate Director, US Food and Drug Administration
Woei Jiuang Wong
Director, Health Sciences Authority, Medical Device Branch, Health Products Regulation Group, Singapore

23. Working Group

24. Thank you very much