Medical Devices & IVDs

The medical device industry encompasses a wide variety of products.

Companies wishing to sell their devices in South Africa are required to be licensed in terms of the Medicines and Related Substances Act (Act 101 of 1965).

The Quality Management expectations are governed by ISO 13485:2016, which was also adopted as a South African National Standard [SANS 13485:2017].

Services Include:

  • Product Classifications
  • License Applications & Updates
  • Design and Implementation of Quality Management Systems
  • Writing of Quality Manuals
  • Development and Implementation of Standard Operating Procedures
  • Collation of Standard Technical Documents
  • Review of regulatory information with a gap analysis report
  • Vigilance monitoring
  • Auditing
  • Technical agreements with third party contractors

Contact us today!