Communication to industry Archives - Page 16 of 22

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

Posted at 22:28h in

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 in

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 in

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 in

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 in

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...

22 Feb Priority Review Requests Communication

Posted at 19:16h in

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....

09 Feb Medical Device Establishment Licence Renewal Process

Posted at 12:30h in

License Renewal Q and A to support communication

Date updated

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Archive

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

31 Mar Upcoming SAHPRA and Industry workshop

30 Mar Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines

07 Mar Communication to industry – 7.04 Health Supplements Safety and Efficacy

03 Mar Requests: Existing Category D (Complementary Medicines) Registration Applications (07 October 2021)

22 Feb Priority Review Requests Communication

09 Feb Medical Device Establishment Licence Renewal Process

Archives

Date updated

07 Feb Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication

01 Feb Transitional Arrangements for Medical Devices

01 Feb Medical Device Establishments: License Requirements

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