WHO NRA assessment tool: medical devices and diagnostics

Transcription

1 WHO NRA assessment tool: medical devices and diagnostics Prepared by Irena Prat Technical Officer Essential Medicines and Health Products 2 nd WHO Global Forum on Medical Devices 1

2 Medical devices regulations landscape In most jurisdictions MD and Dx regulation is relatively new Harmonization of regulatory requirements among different jurisdictions is still suboptimal, although improving Jurisdictions are confronted to the challenging task of ensuring a good balance between timely availability of the latest technology the need to ensure safety and performance of MD Ensuring sustainable good quality of MD requires a strong incountry regulatory system, including pre- and post-market regulations 2

3 The GHTF/IMDRF 1993: senior regulatory officials and industry representatives from the EU, USA, Canada, Japan and Australia established a global consultative partnership aimed at harmonizing medical device regulatory practices: GHTF The GHTF was a voluntary group of representatives from national medical device regulatory authorities and the regulated industry The purpose of the GHTF was to encourage convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of MD, promoting technological innovation and facilitating international trade. The primary way in which this was accomplished was via the publication and dissemination of harmonized guidance documents on basic regulatory practices. Guidance principles can be adopted/implemented by NRAs. As of 2011: GHTF IMDRF International Medical Device Regulators Forum 3

4 The GHTF 5 GHTF Study Groups Study Group 1 - Premarket Evaluation Study Group 2 - Post-Market Surveillance/Vigilance Study Group 3 - Quality Systems Study Group 4 - Auditing Study Group 5 - Clinical Safety/Performance The GHTF regulatory model the core and basic elements supported by GHTF guidance documents 4

5 GHTF regulatory model: key subsystems Risk-based PM control PMS system These elements are interrelated and mutually interdependent. QMS and RM process encompassing life cycle Regulatory process to periodically assess conformity 5

6 HO NRA assessment tool for MD and Dx In 2009 developed a tool for a baseline analysis in capacity building pilot project countries shall yield an overview of the NRAs' regulatory functions and their effectiveness in ensuring the safety and performance of diagnostics A series of indicators assess the legal base, responsibilities, processes, procedures and performance of the regulatory functions 6

7 HO NRA assessment tool for MD and Dx General information on Member State and assessment National regulatory system Organization Legal basis for the establishment of the regulatory system for MD and diagnostics National regulatory authority for MD and diagnostics (NRA) Legal basis General information Institutional development Organization and structure Quality management system (QMS) Funding Management of human resources Committees and external experts Transparency and confidentiality Independence and impartiality Infrastructure Information management systems Communications activities 7

8 NRA assessment tool MD and diagnostics regulation overview MD and Diagnostics Premarket Regulation MD and Diagnostics Post-Market Regulation Regulatory oversight Inspections Evaluations Register or list Outsourcing Guidelines Post-market regulation oversight Penalties Adverse Events Field Safety Corrective Actions Reciprocal Arrangements Batch Release Information Laboratory Networks Register / list 8

9 NRA assessment tool Licensing of MD and diagnostics manufacturers Licensing of importers, exporters, wholesalers and distributors of MD and diagnostics Control of MD and diagnostics promotion and advertising Clinical trials International cooperation and harmonization National reference laboratory for diagnostics Legal basis Guidelines Ethical oversight Organization and structure Assessment procedures Human and other resources Records and outputs 9

10 HO common assessment tool for medica products Medicines, vaccines, medical devices and diagnostics Common structure: regulatory functions, indicators and product-specific flexible indicators/sub-indicators Integration of the harmonized tools into the NRA assessment database 10

11 Thank you for your attention Questions? 11