To achieve certification to the ISO13485 standard for medical devices, the certification process requires each medical device establishment to implement a formal QMS which must be inspected and certified by an independent conformity assessment body (CAB) which has in turn been accredited by The South...
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...
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....
As of the 1st of April 2022, the post-importation testing exemption requests for Biological and Biosimilar medicines should be submitted as per the requirements of Guideline 2.04. For submission process, please refer to section 3.0 Post-Importation Testing Exemptions (PITE)....
The purpose of Guideline 7.04 (Complementary Medicines - Health Supplements Safety and Efficacy) is to provide clear guidance with regard to the safety and efficacy (SE) requirements for registration of Health Supplements as a subset of complementary medicines in South Africa in the Common Technical...
The corresponding stakeholder notice dated 07 October 2021 regarding the opportunity to update online the application details and/or the submission before review refers.
A further opportunity to resubmit an existing application on the CM portal is made in Phase 2 which is foreseen to extend to...
SAHPRA has a policy to make provision for priority review, for the assessment and registration of medicines that treat serious diseases and is of major public interest....
License Renewal Q and A to support 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....