SAHPRA Regulatory REquirements

This is a curated list of SAHPRA Regulatory Requirements relevant to Medical Devices.

The Medicines and Related Substances Amendment Act, 14 of 2015, has brought significant changes in the regulation of medical devices in South Africa. The highlights include the establishment of a regulatory authority, the South African Health Products Regulatory Agency (SAHPRA), the introduction of a tier-based licensing and registration system, and restriction of bonusing and sampling in the sale of medical devices. The enactment of the new regulations is a positive development for the South African medical device industry. This page seeks to provide curated publicly available information to assist Medical Companies to understand the new requirements and meet their regulatory obligations. The main source for information on the regulation of Medical Devices may be found at

SAHPRA Regulatory Requirements are contained within the Medicines and Related Substances Control Act 101 of 1965, its regulations on Medical devices published in the government gazette, and Guidance documents, position papers and application forms published on the SAHPRA website.

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Acts and Regulations:

Fees Payable:

Fees Payable: Section 6 of Government Gazette No 42474, 24 May 2019 Fees Payable in terms of the Provisions of Medicines and Related Substances Act 101 of 1965 No 695

SAHPRA Bank Details

Guidance Documents

Please note that some documents are “for comment” or in DRAFT format. These have been included as they provide the best available information on the approach or thinking of the Regulator. Care should be taken when looking at these documents that updated or final versions may have been published on the SAHPRA website for Medical Devices and Radiation Control.

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Covid-19 Related Documents

Position Statements

Application Forms

Guideline Wholesaler

Medical Device Registration

Medical Device Registration has not yet started. The guidance documents and application forms are still in DRAFT format. It is anticipated that these will be published for public comment on December 2019. In the interim, the following documents are instructive:

Clinical Trials