WHO Global Regulatory Model Framework for medical devices including IVDs medical devices

1. 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 60.29), 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; http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R20-en.pdf

4. WHO Mandate.... • In the context of Resolution 67.20 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 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

8. Recent publications http://www.ahwp.info/sites/default/files/ahwp-files/4_Technical_Committee/AHWP%20Playbook%20for%20Implementation%20of%20MD%20Reg%20Framework.pdf http://applications.emro.who.int/dsaf/emropub_2016_EN_18962.pdf?ua=1

9. Earlier publications 2001 2011 2003 http://apps.who.int/iris/bitstream/10665/42744/1/9241546182.pdf http://www.imdrf.org/docs/ghtf/final/steering-committee/technical-docs/ghtf-sc-n1r13-2011-ad-hoc-regulatory-model-110413.pdf http://new.paho.org/hq/dmdocuments/2009/AmodelRegulatoryProgramforMedicalDevices_AnInternalGuide.pdf?ua=1

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. Target audience • 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. Two steps approach • 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 • 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: • Establishing a single nomenclature system • Norms and standards for medical devices • Guidance on combination products • Financing of the regulatory system for medical devices

22. Working Group Members (Non-WHO Staff)

23. Working Group

24. Thank you very much