Communication to industry Archives - Page 7 of 23

09 Apr ISO 13485 Certificate as a prerequisite for the approval of a Medical Device Establishment Licence

Posted at 14:23h in

The international standard ISO 13485 (ISO 13485:2016 Medical Devices - Quality Management Systems – Requirements for regulatory purposes) for a quality management system (QMS) is recognised globally to address minimum regulatory requirements for medical devices and in vitro diagnostics (IVDs). The standard outlines the requirements...

08 Apr Communication Regarding the Sealing and Unsealing of Hazardous Substances

Posted at 11:40h in

This document intends to communicate to all the users of Group III and IV hazardous substances about the processes of sealing and unsealing the equipment. The sealing of dangerous substances is an enforcement action and may occur during announced and/or unannounced inspections or in the...

04 Apr SAHPRA Engagement Portal – Emergency Webinars

Posted at 17:27h in

The South African Health Products Regulatory Authority (SAHPRA) announces urgent webinars scheduled for Monday, 07 April 2025, Wednesday, 09 April 2025 and Friday, 11 April 2025 from 14:00-16:00....

03 Apr SAHPRA Engagement Portal – Locating Legacy Applications

Posted at 14:41h in

The South African Health Products Regulatory Authority (SAHPRA) Engagement Portal launched on 01 April 2025. We thank applicants for embracing the new system, quickly adapting to it, and promptly bringing to our attention any challenges encountered. This communication seeks to resolve a frequently encountered challenge...

02 Apr Payment of Retention Fees for the Year Ending 31 December 2025

Posted at 08:50h in

Your attention is drawn to the provisions of the Medicines and Related Substances Act, 101 of 1965, as amended, which provide for the payment of retention fees to the South African Health Products Regulatory Authority (SAHPRA) in respect of medicines registered and medical devices, including...

01 Apr SAHPRA Engagement Portal – Launch Update

Posted at 11:52h in

Applicants are hereby notified that the South African Health Products Regulatory Authority (SAHPRA) Engagement Portal is set to launch at midday on 01 April 2025....

01 Apr SAHPRA Engagement Portal – Application IDs

Posted at 10:11h in

This communication serves to notify applicants about the issuance of Application IDs. Following the administrative freeze (ending 31 March 2025), newly generated Application IDs will be available on the portal for each application, encompassing all strengths and multiples combined. In accordance with eCTD Specification 3.1,...

12 Mar Regulatory Information Management System – Cancellation of Health Product Registrations for non-eCTDs

Posted at 09:37h in

This communication aims to provide an update to applicants regarding a South African Health Products Regulatory Authority (SAHPRA)-initiated grace period for cancelling the registration of health products not in eCTD format. Post the implementation of the eCTD 3.1 submissions process, SAHPRA has started to receive communication...

10 Mar Clinical Trials Conduct – USA Government Funding Pause/stop

Posted at 10:33h in

This communication is issued given the current uncertainty about US government funding for healthcare in South Africa, particularly in clinical research, and it intends to emphasise the responsibilities of various stakeholders in Clinical Trials....

10 Mar Comm Issue No.PEM01-CEM01-2025 – Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)

Posted at 09:27h in

This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all applicants/Holders of Certificates of Registration (HCRs) who intend to submit/have submitted applications supported by bioequivalence studies conducted by Synapse Labs Pvt. Ltd, a Contract Research Organisation (CRO) located...

Archive