The COVID-19 Medical Device Regulatory Convergence Project (MDRC) and the South African Health Products Regulatory Authority (SAHPRA) held two Sessions on Good Regulatory Practices and Its Implementation in the Medical Device Sector, which took place on 10 and 11 August 2022.
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.
Agenda
Session I
Recording
Presentations
Introduction and Overview on Good Regulatory Practices (GRP) – Renata Amaral, MDRC
International Benchmarks for Medical Device Regulatory Frameworks and Authorities:
Health References & Recommendations: Good Regulatory Practices and Good Reliance Practices – Agnes Sitta Kijo, WHO
International Benchmarks for Medical Device Regulatory Frameworks and Authorities: Health References & Recommendations – Khanyisile Nkuku, SAHPRA
Trade & Legal References and Obligations:
TBT Agreement and medical devices – Lauro Locks, WTO
Session II
Recording
Presentations
South African Legislative & Regulatory Framework for Medical Devices – Current Situation and Roadmap for the future:
Medical Device Regulations Status – Lydia Motlogelwa, SAHPRA
Review of South African Medical Device Technical Standardization & Stakeholder Participation:
Standards Development Process, Phollen Murivhula, SABS
