The steps, in order
How to get started
- Decide which licence you need. SAHPRA's pharma licensing unit covers manufacturers, importers, exporters and wholesalers or distributors of medicines and scheduled substances. Medical devices and complementary medicines have their own pages and units.
- For a pharma licence, download the application form and guideline for your type: GLF-LIC-01A and SAHPGL-LIC-01 to manufacture, import or export; GLF-LIC-02A and SAHPGL-LIC-02 to act as a wholesaler.
- Prepare a site master file (SAHPRA has a guideline for it) and the supporting documents listed below, and pay the fee with the reference its payment guideline asks for.
- Submit. SAHPRA's page says that from 1 September 2026 new pharma licence applications go through the digital SAHPRA Engagement Portal, and renewals and amendments move there from 1 October 2026. Until then renewals could still go to its pharma licensing mailbox.
- For a medical device establishment, SAHPRA lists three licence types: manufacturer, distributor and wholesaler. You list every device you handle, declare the status of your quality management system, and appoint an Authorised Representative who is a natural person based in South Africa.
Have these ready
Documents and information
- Application cover letter, and proof of payment with the correct reference.
- CIPC, CIPRO or DTI documents proving who owns the business.
- National Department of Health premises licence, or a copy of your completed application for one.
- Registration of the responsible pharmacist (or the SAPC case number), the SAPC certificate of recording of a pharmacy and of the pharmacy owner (or case numbers).
- Latest inspection resolution, and your existing licence, if you are renewing or amending.
- Proof of the annual licence retention fee for earlier years if the licence is older than a year, and a product list with proof of each product's annual retention fee (for the products it applies to).
- Submit as one zipped file (SAHPRA's instruction for pharma applications).
Be realistic
What to expect
SAHPRA's medical devices page says no medical device may be manufactured, distributed, imported, exported or sold without a valid establishment licence, and that evidence of a valid licence is required to be eligible to bid for national and provincial tenders. A manufacturer, distributor or wholesaler of non-sterile, non-measuring Class A devices is exempt (SAHPRA position statement 9.106). On renewal, device manufacturers and distributors must show ISO 13485 certification from an accredited conformity assessment body.
Watch out for scams. Our advice, not an official warning: apply only through sahpra.org.za or portal.sahpra.org.za, use the e-mail addresses printed on SAHPRA's own page, and never pay a person who promises to 'fast-track' a licence.
What we could not confirm. Current fee amounts and how long a decision takes. The exact device-licence documents list (it sits in SAHPRA's guidelines for medical device establishments). Product registration (a separate process from an establishment licence).
Official pages
Start at the source
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