Core Elements of Medical Device Regulatory Systems in Developing Countries

Transcription

1 Core Elements of Medical Device Regulatory Systems in Developing Countries Strengthening Regulatory Systems in Developing Countries Institute of Medicine Washington, D.C.; 2-3 March Mar-11 M. Gropp; Medtronic, Inc., Minneapolis, USA

2 Introduction General overview Scope Current situation Focus on regulation, not reimbursement, funding, procurement, or health technology assessment Not covering in vitro diagnostic medical devices High level overview, risks of over-generalizing Speaking in personal capacity 2

3 Differences between Medical Devices and Drugs Medical Devices Drugs Physical objects; complex components and assemblages; generally based on mechanical, electrical, and materials engineering Most act through physical interaction with body or body part Tend to require significant user interaction Heterogeneous group; range from tongue depressors to artificial hearts Pure molecules; based on pharmacology and chemistry; now encompassing biotechnology, genetic engineering, etc. Administered by mouth, skin, eyes, lungs, or by injection; act through metabolic, pharmacologic, or immunologic means Generally little user interaction Tend to differ only in molecular structure, active site, mode of app. 3

4 Differences between Medical Devices and Drugs Medical Devices Drugs Duration and nature of exposure varies widely Invented and designed; often with involvement of physician users Short market life (~ months) Typically short half-life in body Discovered in lab-based research processes Long market life Over 80% small and medium sized enterprises Some require service and repair, mfr. technical training and support Very large multi-national companies dominate No service or maintenance 4

5 Diversity of medical devices Source: US FDA CDRH 2005 Strategic Plan (modified) 5

6 Definition Global Harmonization Task Force Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: a) Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of Source: GHTF/SG1/N29R16:2005; Information document concerning the definition of the term Medical device ; Global Harmonization Task Force: At; (under revision) 6

7 Definition Global Harmonization Task Force. specific purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment or alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, Source: GHTF/SG1/N29R16:2005; Information document concerning the definition of the term Medical device ; Global Harmonization Task Force: At; (under revision) 7

8 Definition Global Harmonization Task Force. specific purpose(s) of: supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; Source: GHTF/SG1/N29R16:2005; Information document concerning the definition of the term Medical device ; Global Harmonization Task Force: At; (under revision) 8

9 Definition Global Harmonization Task Force. and b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means Source: GHTF/SG1/N29R16:2005; Information document concerning the definition of the term Medical device ; Global Harmonization Task Force: At; (under revision) 9

10 Early regulation of medical devices In some countries, some medical devices originally regulated as medicines, e.g., sutures 1976 US medical device amendments to Federal Food, Drug and Cosmetic Act Established device-specific provisions to Act and authority for device-specific regulations Established devices Center Added to existing enforcement structures Comprehensive regulatory framework Risk-based classification Pre- and post-market controls 10

11 Early regulation of medical devices In some European countries in 70s, regulatory focus on certain aspects of devices safety Sterility Electrical safety National standards Often required testing by government/test houses UK focus on supplier quality systems 11

12 Early regulation of medical devices European Community medical device directives in early to mid-90s Based on Community legislation in other sectors Principle of mutual recognition and free circulation in Internal Market Harmonized regulatory requirements Drew together elements of pre-existing national approaches Regulatory controls proportional to risk-based classification Established conformity assessment processes and bodies 12

13 Early regulation of medical devices European Community medical device directives in early 90s (cont d) Recognized international standards Regulatory responsibilities at Member State and EU levels (but no central regulatory authority) Now apply throughout European Union and European Free Trade Association Member States Model for international regulatory harmonization guidance Growing US-EU regulatory cooperation 13

14 Early regulation of medical devices Similar evolution in Australia, Canada, and Japan Australia 1989 Therapeutic Goods Act amended to cover all medical devices; 2002 amendments for international harmonization Canada 1998 medical device amendments to federal Food and Drugs Act Japan 2002 amendments to Pharmaceutical Affairs Law Australia, Canada, EU, Japan, and USA are Founding Members of Global Harmonization Task Force (GHTF) ~ 90% of global production (today) 14

15 Elements of medical devices regulatory systems Definition of medical device Registration of mfrs., importers, and distributors and devices placed on national market Risk-based classification system and controls Oversight/controls for clinical investigations Quality management system/gmp requirements Requirements for safety, performance, and quality Labelling requirements Clinical evidence requirements Recognition of standards Pre-market conformity assessment Post-marketing surveillance, adverse event reporting, field safety corrective actions/recalls 15

16 Status of regulation of medical devices About 85 countries today regulate medical devices in some fashion*: Countries with comprehensive regulatory systems specific to medical devices (e.g., GHTF Founding Members) Varying degrees of harmonization Countries with comprehensive advanced regulatory systems Harmonized (e.g., Singapore, Chinese Taipei) Not harmonized (e.g., Brazil, Korea, Thailand) * semi-arbitrary, imprecise, overlapping, categorization; illustrative examples only 16

17 Status of regulation of medical devices About 85 countries today regulate medical devices in some way (cont d): Countries with less advanced, less comprehensive unharmonized regulatory systems (e.g., China) Economies with harmonized, but not comprehensive, regulatory systems (e.g., Hong Kong SAR) 17

18 Status of regulation of medical devices About 85 countries today regulate medical devices in some way (cont d): Countries with non-comprehensive regulatory controls for some devices based on drugs regulations (e.g., India, Ethiopia) Countries with basic controls, e.g., registration of importers and/or producers (e.g., New Zealand, Bangladesh, Sri Lanka, some Caribbean, South and Central America, and north Africa countries) Countries with no regulatory controls (e.g., sub- Saharan Africa, central Asia) 18

19 Status of regulation of medical devices Many new systems being developed and/or implemented (e.g., Saudi Arabia, Malaysia, Indonesia, South Africa, Russia, Pakistan, ASEAN, UAE) Slowly growing web of bilateral mutual recognition agreements (e.g., EU-Switzerland, EU-Australia) and joint assessments (e.g., US and Canada) In a few cases, acceptance of marketing authorization in designated countries as evidence of substantial conformity with importing country requirements (e.g., Mexico) 19

20 Status of regulation of medical devices World Health Organization Guidance for member states on medical device regulation (2003) generally based on GHTF model Some procurement standards for some devices No direct role in device nomenclature First Global Forum on Medical Devices (Bangkok, Sept. 2010) highlighted need for regulatory capacitybuilding in less and least developed countries 20

21 Conceptual qualitative overview of current national medical device regulatory systems Harmonization (GHTF/AHWP) High Low Low Comprehensiveness High 21

22 Conceptual qualitative overview of current national medical device regulatory systems Harmonization (GHTF/AHWP) High Low New Zealand Low Hong Kong SAR Pakistan South Africa India Bangladesh Argentina Mexico Colombia Thailand Brazil Comprehensiveness EU, EFTA Saudi Arabia Chinese Taipei China Korea Australia Singapore Canada Japan USA Notes: Position in clusters not necessarily significant Subjective assessment of many variables Variables not weighted Not all countries that regulate medical devices shown High 22

23 Conceptual qualitative overview of current national medical device regulatory systems Trends Harmonization (GHTF/AHWP) High Low New Zealand Low Hong Kong SAR Pakistan South Africa India Bangladesh Argentina Mexico Colombia Thailand Brazil Comprehensiveness EU, EFTA Saudi Arabia Chinese Taipei China Korea? Australia Singapore Canada Japan USA Notes: Position in clusters not necessarily significant Subjective assessment of many variables Variables not weighted Not all countries that regulate medical devices shown Some countries moving faster than others and with different paths High 23

24 Conclusions Regulatory systems for medical devices differ from those for medicines and other regulated products Regulatory controls proportional to risks, linked to device life cycle Medical device regulation more recent and evolving rapidly Development and production becoming more geographically widespread Wide range of capacity, comprehensiveness, and international harmonization among national regulatory systems 24