Archive
01 Apr Conformity assessment body(cab) requirements for recognition by Sahpra checklist
Posted at 14:32h
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2022 Mar...
01 Apr Usability studies for Covid-19 self-testing kits requirements
Posted at 14:17h
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On the 5th of March 2020, Minister of Health Zweli Mkhize confirmed the spread of the virus to South Africa, with the first known patient being a male citizen who tested positive upon his return from Italy. The vast range of self-testing kits as well...
01 Apr Conditions for use of COVID-19 antigen self-test kits
Posted at 14:14h
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The primary goal of self-testing is to aid with the early detection of SARS-CoV-2, reduce transmission, and enable people to follow public health measures to control COVID-19 and keep societies open during the pandemic. Ag-RDT self-tests play an important role in enabling decentralised testing and...
01 Apr ISO 13485 Conformity Assessment Body Communication
Posted at 09:48h
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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...
31 Mar Communication to Stakeholders with regards to the current status of the Medical Device Regulations
Posted at 22:28h
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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
Posted at 22:26h
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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....
30 Mar Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines
Posted at 09:35h
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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)....
07 Mar Communication to industry – 7.04 Health Supplements Safety and Efficacy
Posted at 16:39h
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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...
03 Mar Requests: Existing Category D (Complementary Medicines) Registration Applications (07 October 2021)
Posted at 11:01h
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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...