The Medical Device Regulatory Convergence (MDRC) Project in collaboration with the South African Health Products Regulatory Authority (SAPHRA) prepared Capacity Building Sessions on Good Regulatory Practices, Good Reliance Practices and International references. The event took place in Pretoria, South Africa from 14 to 16 November, 2023. National Regulatory Authorities from Australia, Brazil, Singapore, the United…

MDRC convened Kenya Bureau of Standards, Pharmacy and Poisons Board, African Regional Standards Organization, US Food and Drug Administration, International Electrotechnical Commission and Medak to discuss on opportunities to streamline Conformity Assessment and Import process of Medical Devices. Agenda Recording Presentations Conformity Assessment IECEE CB Scheme. The Whats and the Hows – Steven Margis –…

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…

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…