Jul 1, 2022

The South African Health Products Authority (SAHPRA) has issued several new regulatory documents that medical device and in vitro diagnostic (IVD) device manufacturers should review to confirm compliance. First, SAPHRA has finalized regulatory guidance regarding the release of imported health products at ports of entry. Second, the regulator has updated rules for advertising medicines and health products. Third, SAPHRA has published rules for the safe disposal of pharmaceutical products.

South Africa’s guidance on release of imported health products at ports of entry

SAHPRA posted Guideline for Release of Imported Health Products at Ports of Entry. This guidance outlines the requirements for clearance to release imported health products, including medical devices, at the seven ports of entry located in South Africa. Specific requirements for product samples, as well as products intended for personal use, are outlined in the document.

SAHPRA regulatory guidance on advertising medicines and health products

SAHPRA has also finalized Guidelines for Advertisement of Medicines and Health Products to clarify its rules on the general requirements for advertising medicines and health products (including medical devices and IVDs) in South Africa.

South Africa issues rules on safe disposal of pharmaceutical products

The South African medical device market regulator has published Guidelines for Safe Disposal of Unwanted Pharmaceutical Products. This guidance describes the proper handling, treatment and safe disposal of health products, including medical devices. Notably, any person who is in possession of unwanted products (i.e., health products that do not meet the regulatory requirements; products that are withdrawn from the market due to safety, efficacy and quality issues) must obtain an Authorization for Disposal from SAHPRA.

Emergo by UL advisors will add further details on South Africa’s regulations as regulators release them.

Learn more about medical device regulation in South Africa:

  • South Africa medical device and IVD approval process resource
  • South Africa Medical Device Regulatory Strategy Report consulting
  • South Africa Medical Device Regulations resource
  • South Africa Department of Health resource
  • Expand globally with regulatory reports resource

 

Author

  • Kathryn Burke's picture
    Kathryn Burke

Related