1. Dr Manisha Shridhar Regional Advisor WHO-SEARO
South East Asia Regulatory Network – SEARN for access to quality, safe and affordable Medical Devices and diagnostics
Dr Manisha Shridhar
Regional Advisor WHO-SEARO
Disclaimer: No Conflict of Interest

2. Regulatory and Trade Context is different in different Medical Products
Medicines (relatively well established) , Vaccines (well established ‘closed’ system), diagnostics (developing), devices (developing )
Drug Regulatory Authorities largely Pharmacists for medicines
Match roles to requirements of different product- product obsolescence in devices
Challenges in use:
role of pharmacies in drugs
certain use by the patients/ people themselves - with little or no medical information- instructions and labelling requirements – manufacturers seen as responsible
Supply line challenges- storage – role of regulators and regulation
Assist limited liability to the manufacturer
Other Organization statutes and rules e.g. Customs organization
Role of courts – robust interpretation of laws of contract – encourage legal awareness

3. Regulation of medical devices
‘Medical devices’ originally regulated as medicines, e.g., sutures
1976: US medical device amendments to Federal Food, Drug and Cosmetic Act
Established devices Center
Comprehensive regulatory framework
Risk-based classification
Pre- and post-market controls
European Community medical device directives in early to mid-90s

4. Global Harmonization Task Force (GHTF)
1993: Global Harmonization Task Force (GHTF) founded in 1993 by governments and industry
An early example of partnership – public private partnership (PPP) Mode in public health (1990 International Council for Harmonisation (ICH) bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration).
Founding members: Australia, Canada, Japan, the European Union, and the United States of America
GHTF to encourage convergence in standards and regulatory practices
Goals: safety, performance and quality of medical devices
Promote technological innovation and facilitates international trade
Methodology: publication and dissemination of harmonized guidance documents for basic regulatory practices

5. Medical devices are special – SEARN context
Map existing resources – facilities etc. (listing of key expertise and knowledge already there?)/ regulatory capacity
Task division and sharing
Procedures for reliance on what others are doing
Adoption of PQ/ Abbreviated PQ procedures- [ PQ is an assessment in time]
Region specific responses
Opportunities for learning specialized knowledge
Collaborative procedures to forge reliance?
Strengthen key areas
Track industry trends in mergers and acquisitions – intelligence through the market place – ISO Certifications
Ensure consistency in quality of products
Putting a dossier together
Post marketing surveillance / vigilance of medical products – efficient migration of information from disease programs to regulatory reporting systems
Problems with product/ use of product?

6. Elements of medical devices regulatory systems
Definition of ‘medical device’
Registration of manufacturers, importers, and distributors and devices placed on national market
Risk-based classification system and controls
Quality management system/GMP requirements
Requirements for safety, performance, and quality
Labelling requirements and trade requirements
Clinical evidence requirements
Oversight/controls for clinical investigations
Recognition of standards- national/ international
Pre-market conformity assessment
Post-marketing surveillance, adverse event reporting, field safety corrective actions/recalls

7. Critical for achievement of health and other SDGs

8. Access to Medical products is in SDG -3
The SDG3 emphasises the promotion of health throughout the life course and universal health coverage (UHC)
Expand access to quality assured medicines and health products -
Ensure that quality essential medicines and health products are available in sufficient quantities and affordable to the population through functioning regulatory and procurement systems
Focus on research and development efforts on diseases that disproportionately affect developing countries

9. 4 September 2018 – Ministerial Round table on Access to medical products in South-East Asia Regional Committee

10. Delhi Declaration- Access to Medical products (medicines, vaccines, devices, diagnostics)

11. South East Asia Regulatory Network ( SEARN)
Main Objective: Information sharing: Create an enabling environment to enhance communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities as approved by Network members.
Formation of Steering Group and Working Groups for
Quality assurance and standards of medical products, including labs
Good Regulatory Practices (GRP) including GMP, GDP etc.
Vigilance for medical products
Medical devices and Diagnostics
Information Sharing Platform

12. Working Group 5: Medical devices and diagnostics
Map medical device regulations for SEARN countries for current situation
Map capacity building needs for each country
Enhance capacity inquality control of Medical devices and diagnostics