Medical Device Regulatory Requirements in South Africa

Regulatory Authority South African Health Products Regulatory Authority (SAHPRA)
Regulatory Authority Website Link Click Here
Device Classification A,B,C,D
Medical Device Regulations Medical Devices And In Vitro Diagnostics Guidelines (Same Regulations for IVD) | Click Here
IVD Classification A,B,C,D
In Vitro Diagnostics Regulations Medical Devices And In Vitro Diagnostics Guidelines
Device Classification Guidelines Guidelines for medical device ad IVD classification | Click Here
Registration Process Licensing of Medical Device Establishments | Click Here
Registration Timeline 2 months
Conformity Assessment Route

Foreign CAB

  1. Submit application to SANAS

  2. SANAS to issue letter of authority

  3. Submit letter of authority and application to SAHPRA

  4. SAHPRA to recognize

  5. Publish on the SAHPRA website

Local CAB

  1. Submit application to SANAS for accreditation

  2. SANAS to issue accreditation certificate as per scope

  3. Submit accreditation certificate to SAHPRA

  4. SAHPRA to designate

  5. Publish on the SAHPRA website

| Click Here
Requirement of Authorized Representative Yes
Language Requirement Documentation and labelling must be provided in English.
Clinical Trials Information

Clinical Trials Guidelines

| Click Here
Certificate of Free Sale

A Certificate of Free Sale may only be issued to a SAHPRA medical device establishment licence holder, who is authorised by SAHPRA to manufacture medical devices.

The Certificate of Free Sale serves as confirmation by SAHPRA that the manufacturer is:
▪ the legal original manufacturer; and
▪ licensed by SAHPRA to manufacture the medical device/s

| Click Here
Post Market Surveillance

Guidelines for Post Marketing Surveillance of Medicines and Health Products.

| Click Here
Additional Information

There are 2 different screening processes that take place for a medical device establishment license application- that is the administrative and technical screening.
Contact Phone (012) 501 0300
Contact Email enquiries@sahpra.org.za
Contact Address South African Health Products Regulatory Authority Private Bag X828 Pretoria 0001
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 09/Jul/2025

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