Medical Devices & IVDs

The medical device industry encompasses a wide variety of products including In Vitro Diagnostics. The South African Health Products Regulatory Authority (SAHPRA) has issued several guidelines that relate to the regulations published on 9 December 2016 and qualify the compliance expectations.

Companies wishing to sell MDs & IVDs in South Africa are required to be licensed in terms of the Medicines and Related Substances Act (Act 101 of 1965, as amended). The Quality Management expectations are governed by ISO 13485:2016, which was also adopted as a South African National Standard [SANS 13485:2017].

In terms of product registration:

  • SAHPRA is currently reviewing comments received on the registration guidelines and forms. Call-ups for registration of MDs and IVDs are awaited as soon as the final guidances are communicated.
  • The Directorate: Radiation Control is responsible for the issuing of licenses for Electromedical Devices in terms of the Hazardous Substances Act (Act 15 of 1973, as amended).

We can assist with the following:

  • Product Classifications
  • License Applications & Updates
  • Design and Implementation of Quality Management Systems, including the creation of Quality Manuals
  • Development and Implementation of Standard Operating Procedures
  • Collation of Standard Technical Documents
  • Review of Labels and IFUs

 

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