Communication to industry Archives

10 Apr Licensing Requirements for Outsourced or Contracted Activities for Medical Device Establishments

Posted at 13:10h in

This is intended to provide stakeholders with guidance and the requirements for medical device (including In Vitro Diagnostics (IVDs)) manufacturers, distributors and wholesalers who appoint or contract a third party to perform manufacturing, distribution or wholesaling activities on their behalf, for the purpose of placing...

01 Apr Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant: Extension of Deadline for Written Submissions and Updated Meeting Date

Posted at 21:20h in

The South African Health Products Regulatory Authority hereby issues an update to all Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines, following the communication dated 23 March 2026. Download previous version ...

01 Apr E2B Standard as Acceptable Method of Reporting SAEs Occurring During Clinical Trial Conduct to SAHPRA

Posted at 16:02h in

This document is intended to provide communication to various stakeholders conducting Clinical Trials on allowed method for Serious Aderse Events (SAE) reporting to SAHPRA....

31 Mar Medical Devices Registration Feasibility Study report

Posted at 15:01h in

The purpose of the Medical Device Registration Feasibility Study was to support the South African Health Products Regulatory Authority (SAHPRA) in advancing the implementation of a comprehensive regulatory framework for medical devices, including in vitro diagnostics (IVDs), within South Africa. The study aimed to evaluate...

30 Mar SAHPRA Advisory on the Use of Unregistered Veterinary Products

Posted at 14:43h in

This document is intended to provide communication to all veterinarians and Veterinary Institutions in the Republic of South Africa to reinforce the importance of compliance with national legislation regarding the use of unregistered veterinary medicines. As stewards of animal health and welfare in South Africa,...

27 Mar Variations Communication

Posted at 11:34h in

This notice provides an update to industry regarding Type II variation pilot submission windows....

26 Mar Payment of Retention Fees for the Year Ending 31 December 2026

Posted at 08:28h in

The Medicines and Related Substances Act No. 101 of 1965 as amended makes provisions for the payment of retention fees to the South African Health Products Regulatory Authority (SAHPRA) in respect of medicines registered, medical devices, including in vitro diagnostics (IVDs), establishment licences issued. These...

25 Mar Applications for Import of Medical Devices for Personal Use

Posted at 14:47h in

The purpose of this document is to provide guidance to members of the public who intend to import Medical Devices/ In-Vitro Diagnostics (IVD) into the country for personal use....

25 Mar Once-off Renewal of Expired Resolution Letters for Low-risk GDP Sahpra Pharma Licensed Sites One-time Renewal of Expired Gdp Resolution Letters

Posted at 11:24h in

This communication is intended to inform the relevant GDP license holders of the one-time renewal of expired GDP resolution letters. SAHPRA is introducing this initiative as a targeted measure to strengthen compliance management while addressing operational challenges. Frequently Asked Questions (FAQ): One-Time Renewal of Expired GDP...

26 Feb ZAZIBONA Centralised Procedure Applications SAHPRA’s Reliance Process

Posted at 10:35h in

SAHPRA is committed to supporting regulatory convergence and harmonisation initiatives across the SADC Region to enhance timely access to quality, safe, and effective health products. In alignment with this goal, SAHPRA has implemented a reliance pathway utilising assessments conducted under the ZAZIBONA Centralised Procedure....

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