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

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

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.

Regulation of medical devices: global

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.)

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

Earlier publications 2001 2003 2011 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

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

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

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

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.

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

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

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

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

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.

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

Working Group

Thank you very much