SAHPRA Medical Device Regulatory Requirements – Mark Banfield & Associates Consulting (Pty) Ltd

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 www.sahpra.org.za

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:

SAHPRA Bank Details

SAHPRA Regulatory Requirements – 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 https://www.sahpra.org.za/Publications/Index/1 under Medical Devices.

2.45 – Borderline Products (DRAFT)
6.04 – Medical Device Wholesaler (DRAFT)
8.01 – General on Medical Devices (DRAFT)
8.02 – Essential Principles for Medical Devices (DRAFT)
8.03 – Conformity Assessment for Medical Devices (DRAFT)
8.04 – Recall, Adverse Event and Post Marketing Vigilance Reporting for Medical Devices (FINAL)
8.05 – Classification of Medical Devices (FINAL)
8.06 – Assess and control of medical devices (DRAFT)
8.07 – Medical Device Quality Manual (FINAL)
16.03 – License to Manufacture, Import, Export or Distribute Medical Devices (FINAL)
16.04 – License to Wholesale Medical Devices (DRAFT)

Position Statements

9.76 – Disinfectants, Antiseptics and Germicides
Q&A on Licencing of Medical Device Establishments
Payments to SAHPRA (Council refers to the MCC but their bank details have not changed)
Transitional Arrangements
Practice Note on Classification of Tissue Engineering Products
Section 21 Applications for Medical Devices
Class A Medical Devices
Section 36(1) Exemption for Sections 18A and B (Bonusing and Sampling)
Acknowledgement Letters no longer permitted – Published 23/12/2019
License Amendments – product changes – Published 23/12/2019
Reprocessing of Single User Devices – Published 23/12/2019

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