Can a wholesaler import medical devices?

No. SAHPRA's Q&A guideline on licensing (SAHPGL-MD-07 v4) states that a wholesaler's licence does not permit you to import or export medical devices.

Who is the Authorised Representative?

Under the Medical Devices Regulations, a natural person resident in South Africa who is responsible for all aspects of the medical device, including its performance, quality, safety and compliance. They sign the application cover letter.

How long is a medical device establishment licence valid?

Five years from the date of issue (regulation 6(1)), with an annual retention fee in between and a renewal application due at least 90 days before expiry.

SAHPRA medical device establishment licence: what you need, step by step

Licence applications rarely stall on the form. They stall on the quality system behind it. This is what SAHPRA's published guidance asks for, and where the quality system fits in.

Last checked against its sources on 23 October 2026.

Who needs a licence

Section 22C(1)(b) of the Medicines and Related Substances Act and regulation 5 of the Medical Devices Regulations (2016) require a licence to manufacture, import, export, distribute or wholesale medical devices and IVDs. The Regulations define the roles:

Role	In the Regulations
Manufacturer	Responsible for the design, manufacture, packaging and labelling of a device
Distributor	Imports or exports a registered device and sells it to healthcare professionals, institutions, wholesalers or users
Wholesaler	Buys devices from a manufacturer or distributor and sells them to a retailer

SAHPRA's Q&A guideline is explicit that a wholesaler's licence does not permit you to import or export. If you bring devices into the country, you need the distributor (import) licence. SAHPRA's licensing guideline also records an exemption, until further notice, for establishments dealing only in Class A devices; check it applies to you before you rely on it.

The forms

GLF-MD-06A: licence to manufacture.
GLF-MD-06B: licence to wholesale.
GLF-MD-06C: licence to import, distribute or export.
SAHPRA publishes the current versions on its medical device application forms page. Check the version there before you submit; forms are revised.

What the application must include

SAHPRA's Q&A guideline on licensing (SAHPGL-MD-07 v4) lists what a new application contains:

Regulation 5 also asks for proof of ownership, the Authorised Representative's particulars, and quality management system certification. The Authorised Representative is a natural person resident in South Africa, responsible for all aspects of the device, including its performance, quality, safety and compliance.

A cover letter on company letterhead, signed by the Authorised Representative.
The application form in Excel and PDF, with the PDF initialled and signed.
The Authorised Representative's CV.
A Quality Manual (manufacturers and distributors) or a Site Master File (wholesalers).
Proof of payment.

The quality system behind the application

SAHPRA is phasing in an ISO 13485 certificate as a prerequisite for licence approval: for renewals from 1 June 2025, and for all applications, including new ones, from 1 April 2028. The Quality Manual you submit is the map of that system. It has to point to procedures that exist and are followed, and every clause you exclude needs a written justification.

So the useful question before you apply is not "do we have a Quality Manual?" It is "which parts of the system behind it are weakest?"

How long a licence lasts

Regulation 6 makes a licence valid for five years from the date of issue. A renewal must be made at least 90 days before it expires, and an annual retention fee is due every year in between. Our guide to renewals and retention fees sets out the calendar.

Common questions

Can a wholesaler import medical devices?: No. SAHPRA's Q&A guideline on licensing (SAHPGL-MD-07 v4) states that a wholesaler's licence does not permit you to import or export medical devices.
Who is the Authorised Representative?: Under the Medical Devices Regulations, a natural person resident in South Africa who is responsible for all aspects of the medical device, including its performance, quality, safety and compliance. They sign the application cover letter.
How long is a medical device establishment licence valid?: Five years from the date of issue (regulation 6(1)), with an annual retention fee in between and a renewal application due at least 90 days before expiry.

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Sources

This guide summarises published documents; it is not legal or regulatory advice. Check the source before you rely on a date or requirement.

ISO-13485 Compliance OS is software, not a regulator, notified body or certification body, and is not affiliated with or endorsed by SAHPRA. Nothing here is legal advice; no regulatory outcome is promised or guaranteed.