Archive

31 Mar Communication to Stakeholders with regards to the current status of the Medical Device Regulations

Subsequent to SAHPRA Medical Device Unit receipt of a number of comments from the public with regards to the medical device regulations. SAHPRA thanks the industry stakeholders for all comments received. The comments were collated and are under review. The final communications will be shared...

31 Mar Upcoming SAHPRA and Industry workshop

As per SAHPRA continuous interaction with stakeholders, Medical Device Unit would like to advise all stakeholders about the intention to host a workshop during the Month of April 2022 with regard to the following topic....

09 Feb Medical Device Establishment Licence Renewal Process

License Renewal Q and A to support communication

Archives

Date updated

07 Feb Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication

Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101 of 1965; the "Act"), to include the regulation of medical devices....