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 Medical Device Regulatory Convergence (MDRC) Project in collaboration with the African Medical Device Forum and the US Food and Drug Administration, prepared a program that was delivered in a hybrid format in Nairobi, Kenya from 6 to 09 November. This workshop will provide an exchange of information and capacity building between the AMDF, its…
The Medical Device Regulatory Convergence (MDRC) Project held a training workshop on Good Regulatory Practices & Technical Competencies in Nairobi Kenya from 22 to 24 August 2023 together with the Pharmacy and Poisons Board (PPB) & the regulated sector. The aim of the workshop was to build joint knowledge about Good Regulatory Practices (GRP) to…
February 28 and March 1, 2023
Asean virtual Regional Workshop on Good Regulatory Practices (GRPs) and Medical Devices Regulation
The Medical Device Regulatory Convergence Project (MDRC) co-lead by USAID, ANSI, and AdvaMed conducted the virtual Regional Workshop on Good Regulatory Practices (GRPs) and Medical Devices Regulation on 28 February and 1 March 2023. The workshop featured discussions the World Trade Organization’s (WTO) Technical Barriers to Trade (TBT) agreement and legal obligations as it relates…
January 31 and February 1, 2023
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…
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…
February 6 and 7, 2023
Webinar on Conformity Assessment for Medical Devices – Personalized Medical Devices
The Medical Device Regulatory Convergence Project (MDRC) held the Webinar on Conformity Assessment for Medical Devices – Personalized Medical Devices on 6 and 7 February. The Webinar had approximately 20 officials attend the two-day session, which focused on conformity assessment and personalized medical devices; the latter topic was included at MOH’s request. The MDRC team also…
7 December 2022
Small-Group Discussion – Quality Management Systems
The Medical Device Regulatory Convergence Project (MDRC) held two Small Group Sessions with Indonesian MOH officials, the first on 7 December 2022 and the second on 6 and 7 February. The event, in partnership with the Ministry of Health, Indonesia, had the purpose to provide opportunity for two-way interaction between international experts and MOH officials…
September 8-9, 2022
Regulatory Training on Medical Device related Standards and Guidance – Indonesia
The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed in collaboration with the Ministry of Health of Indonesia organized a training on International References and Standards on Quality Management System – MDSAP, Artificial Intelligence and Software as Medical Device (SaMD), Clinical Evaluation, Electrical Safety and Performance, and Post-market Surveillance of Medical Devices…