Workshop on Good Regulatory and its implementation in the Medical Device Sector

The COVID-19 Medical Device Regulatory Convergence Project (MDRC) with South Africa and Kenya Medical Device Authorities held on 31 January and February 1st the Workshop on Good Regulatory Practices and its implementation in the Medical Device Sector .

These training sessions intended to promote, through the exchange of experiences, the utilization of Good Regulatory Practices in the process to implement international standards with regulatory purposes for Medical Devices.

The event discussed topics related to Good Regulatory Practices, Trade and Legal References, International Benchmarks for Medical Device Regulatory like the WHO and IMDRF documents, International Standards as a Base for Developing Regulations and the African Medical Devices Forum and its role in regulatory convergence.

Agenda

Recordings

Session 1

Session 2

Presentations

Introduction and Overview on Good Regulatory Practices (GRPs)

International Benchmarks for Medical Device Regulatory Frameworks and Authorities: Trade & Legal References and Obligation

African Regional Trade & GRP – Conversational Focus

International Benchmarks for Medical Device Regulatory Frameworks and Authorities: Health References & Recommendations

International References – international Medical Devices Regulators Forum (IMDRF) Michelle Noonan

International Standards as a Base for Developing Regulations – ANSI

African Regional Standards Organization (ARSO)

Mapaseka Gumbi, South African Bureau of Standards (SABS)

Africa Medical Device Forum – Its role to advance regulatory convergence (15 min) Dimakatso Mathibe