Communication to industry Archives

25 Jun Communication on Research Use Only (RUO) and Investigational Use Only (IUO) Medical Devices including In Vitro Diagnostic Devices (IVDs)

Posted at 13:46h in

This document is intended to provide communication to stakeholders on the regulatory requirements and classification of Research Use Only (RUO) and Investigational Use Only (IUO) medical devices, including in vitro diagnostics (IVD)....

24 Jun Mandatory call up for holders of certificates of registration to submit post marketing adverse event reports for human medicines (serious and non-serious) through Industry e- Reporting VigiFlow module

Posted at 17:55h in

This document is intended to provide communication to all Holders of Certificates of Registration (HCRs)/ Applicants about the mandatory submission of Post-marketing Adverse Event (AE) reports for human medicines through Industry eReporting VigiFlow module. The submission of post-marketing AE reports for human medicines is applicable...

04 Jun Pilot: Clinical Trial Applications Electronic System – Update

Posted at 09:50h in

SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is in progress for new medicinal clinical trial applications from April 2026 and so far included May and June 2026 submission due dates....

01 Jun Regulatory Requirements for Medical Devices Electronic Instructions for Use (e-IFU)

Posted at 10:44h in

The Medicines and Related Substances Act No. 101 of 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 09 December 2016, provides for the regulatory oversight on labelling of...

15 May SAHPRA Warning About Unregistered Peptide Products: What You Need to Know and How To Stay Safe

Posted at 14:51h in

SAHPRA is seeing an increase in unregistered peptide products being sold online, in gyms, and through informal channels. Because these products have not been evaluated and approved by SAHPRA for safety, quality, or efficacy, they can seriously harm your health. If you are unsure about...

07 May Bioequivalence studies performed by Contract Research Organisation (Raptim Research Pvt. Ltd)

Posted at 18:49h 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 Raptim Research Pvt. Ltd, a Contract Research Organisation...

20 Apr SAHPRA Clinical Trials Online Applications Platform

Posted at 10:30h in

Following the launch of the online applications form for CTF1 on the 7th of April and the constructive engagement on 13 April 2026, several enhancements discussed have now been implemented to improve the user experience. All enhancements went live this morning, enabling us to more...

16 Apr Variations Communication

Posted at 16:10h in

The South African Health Products Regulatory Authority (SAHPRA) notifies all applicants that Type II Variations Pilot submission window has been extended from 21 April 2026 to 30 April 2026....

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 ...

Archive