South Africa Medical Device Regulations

All medical devices are regulated by Medicines Control Council (MCC).
Medical Device Definition
A medical device means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent a) used or purporting to be suitable for use or manufactured or sold for use in -i) the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or ii) restoring, correcting or modifying any somatic or psychic or organic function; or iii) the diagnosis or prevention of pregnancy, and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or b) declared by the Minister by notice in the Gazette to be a medical device, and includes any part or an accessory of a medical device. Medicines and Related Substances Control Act, Art. 1.
Classification of Medical Device
Classification Examples Risk Level
A Absorbent pads, syringes without needles, non-sterile dressings Low
B Adhesives for topical use, oxygen tubing and masks, bridges and crown Moderate-Low
C Tubes for blood transfusion, urethral stents, intravenous cannulae Moderate-High
D Cardiovascular catheters, angioplasty balloon catheters, pacemakers High
Premarket Approval Process
Appoint an authorized representative (AR) in South Africa.
Prepare necessary documentation including Conformity Assessment Body (CAB) and Declaration of Conformity (DoC). AR submits application to the Council. Demonstrate the device meets Essential Principles
Demonstrate conformity by applying to a Conformity Assessment Body (CAB) or International Notified Body for the CA certificate.
If the application is successful and CA certificate is granted the RA will now prepare Declaration of Conformity (DoC).
Medical device will be included in the Medical Device register.
Additional Information
Validity Licence issued is valid until guideline is revised.
Postmarket Surveillance Implement necessary corrective actions. Report adverse events and device recalls.
Language ALl documents should be submitted in English
Recent Updates Domestic manufacturers and distributors must register by August 2017. Domestic wholesalers must register by February 2018. Foreign companies must endure SA importers obtain MCC licenses.
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