New Product Filings to date
Variations and Agency Responses filed to date
Shortest time (months) to SAHPRA approval for New Medicine

Latest Industry News

  • Commenting on Medical Device Regulations and SAHPRA fees4 December 2023, 12:14 pm
    SAMED has send submissions on the Health Department’s updated draft Medical Device Regulations and the draft SAHPRA fees for health products that were due by 24 November and 3 November 2023 respectively. The key message in SAMED’s comments is that these regulations must be amended in order to reduce significant risks to all stakeholders...
  • Medical Device Code overhaul1 December 2023, 1:08 pm
    Reasonable hospitality and travel for healthcare professionals (HCPs) and company-organised educational events are just three of 37 provisions covered by the Medical Device Code which have been updated and strengthened. SAMED, led by the Code Committee, undertook an extensive review of the Code over the last few months to close out gaps, align with...