South Africa DOH Guide for Medical
South Africa Market Access for Medical Device
REGULATORY AGENCY
- Department of Health (DOH)
REGULATIONS
- All medical devices, except custom made devices, shall be registered with the council in terms of such call-up notices before they may be sold or used in South Africa.
- A certificate of registration will be issued after a medical device has been registered.
GUIDELINES
- Devices shall be divided into Class A, Class B, Class C, Class D, where risk relates to the patient or to public health.
- A licence issued shall be valid for a period of 5 years from the date of issue.
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