Communication to industry Archives

18 Sep Regulatory Requirements for Importation of Unregistered or Listed Medical Devices for Exhibition, Appraisal, Demonstration, or Training

Posted at 13:23h in

This document provides regulatory guidance for importers, exhibitors, and other applicants seeking SAHPRA approval to import medical devices, including in vitro diagnostic medical devices (IVDs) and unlicenced listed electronic products into the Republic of South Africa for exhibition, appraisal, demonstration, or training. The Medicines and...

15 Sep SAHPRA Integrates the National Immunisation Safety Expert Committee (NISEC) into its Governance and Administrative Framework

Posted at 14:41h in

The National Immunisation Safety Expert Committee (NISEC), formerly a National Department of Health (NDoH) Ministerial Advisory Committee on vaccine safety, now serves as a Technical Advisory Committee within the South African Health Products Regulatory Authority (SAHPRA). This transition integrates NISEC's specialised vaccine-safety expertise into SAHPRA’s...

04 Sep Frequently Asked Questions (FAQ) – Oral Phenylephrine-Containing Products

Posted at 10:56h in

This document consolidates SAHPRA’s responses to questions received from industry stakeholders following its 30 July 2026 communication regarding the lack of effectiveness of oral phenylephrine as a nasal decongestant....

03 Sep Medicines Registry and eCTD Take-On Programme

Posted at 12:27h in

Following the Engagement Portal webinar of 26 August 2026, this communication sets out the key activities and dates for the two programmes that sit with Health Products Authorisation (HPA) and confirms the requirements for their completion....

28 Aug Extension of Notification Deadline – Oral Phenylephrine Pathway Selection

Posted at 18:08h in

In the communication dated 30 July 2026 (COMM Issue No. CLINPR_06_2026_27_Final.pdf), SAHPRA notified all Holders of Certificates of Registration (HCRs) of the final regulatory position regarding orally administered phenylephrine-containing medicines. HCRs were required to notify SAHPRA in writing of their chosen pathway (effectiveness study or...

27 Aug Discontinuation of Industrial Radiographer Registration and RPO Examination

Posted at 14:59h in

This letter serves to officially inform the industrial radiography community SAHPRA has decided to discontinue the following processes within its regulatory operations with immediate effect: Registration of Industrial Radiographers Conducting Examinations for Radiation Protection Officers (RPO) ...

25 Aug Communication to Industry – Participation in the Survey and Pilot Project on the Advertising of Health Products in South Africa (Only Medical Devices & IVDs excluded)

Posted at 17:09h in

The South African Health Products Regulatory Authority (SAHPRA) invites all stakeholders to participate in a survey on the advertising of medicines in South Africa. SAHPRA is mandated by the Medicines and Related Substances Act, 1965 (Act 101 of 1965), to regulate medicines, scheduled substances and...

21 Aug Call for Stakeholders to Verify Their Records – Missing Applications for Variations

Posted at 13:51h in

The South African Health Products Regulatory Authority (SAHPRA) calls on industry stakeholders to verify their records and identify any variation applications that may have been submitted but remain unprocessed due to the transition to the new system. The applications that may have been affected were...

13 Aug Guideline for Health Product Traceability: Update on Implementation

Posted at 15:24h in

As part of implementing the Traceability Guideline on Health Products, the South African Health Products Regulatory Authority (SAHPRA)continues to engage with industry stakeholders, sector associations, and public-sector partners as the project moves from planning phase to delivery. An important part of this work is the survey...

12 Aug General Regulations Made in Terms of the Medicines and Related Substances Act 101 of 1965: Amendment to Regulation 6: Notice of Correction

Posted at 11:43h in

The South African Health Products Regulatory Authority (SAHPRA) wishes to inform all pharmaceutical industry stakeholders that an amendment to Regulation 6 was published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026 for implementation. The published amendment contained two aspects: first, the...

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