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The regulatory authority for medical devices in South Africa

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The regulatory body for the registration of medical devices in South Africa is the South African Health Products Regulatory Authority (SAHPRA), which is primarily responsible for the market access, compliance review, and post-market supervision of medical devices.

Regulatory Authority's Official Website Link:https://www.sahpra.org.za

Database link:https://www.sahpra.org.za/medical-devices-licences-issued/

Administrative Regulation

[Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)]

[Regulations relating to Medical Devices and IVDs, published in the Government Gazette No. 40480, on the 09 December 2016.]

Risk Level Classification of Medical Device and IVD Products

SAPHRA classifies medical devices and IVD (in Vitro Diagnostics) and other medical devices into Class A, Class B, Class C, and Class D:

Requirements for the holder

According to relevant regulations in South Africa, the holder of medical devices must obtain approval and registration from the South African Health Products Regulatory Authority (SAHPRA); it is required that the holder must be a local company.

Authorized Representative

Medical device institutions applying for the SAHPRA license must appoint an authorized representative, and the representative must be a natural person within South Africa. The representative is responsible for complying with laws, regulations and guidelines.

Entry Requirements

(1) South African representative: The South African representative should be a natural person residing in the Republic of South Africa and conducting business there. They must be able to represent the manufacturer, importer, distributor, wholesaler, retailer or service provider of medical devices or IVD products in the registration of products, compliance matters, etc. within the Republic of South Africa, and apply for and hold relevant licenses or registration certificates in their name. The registration application must include detailed information of the South African authorized representative.

(2) Registration documents: Official application form, instruction manual, labels, conformity assessment certificate (CE certificate/other certificates issued by recognized CAB institutions), quality system certificate, compliance with basic principles of safety and performance, etc.

(3) Applications must be submitted for each individual medical device or IVD, for groups or series of medical devices or IVDs, or for their modifications (determined by the committee).

(4) If the medical device or IVD being applied for registration has already been registered with a regulatory authority outside the Republic of South Africa, then the registration certificate must be provided.

Business License

The type of license that needs to be applied for depends on the nature of the activity being conducted:

Manufacturer License: If you are engaged in businesses such as packaging, label production, maintenance or refurbishment of medical equipment in South Africa, you will need to apply for a manufacturer license, as these activities are considered manufacturing activities. The manufacturer application covers manufacturing, as well as import, distribution and export of medical equipment/external diagnostic products, etc. Manufacturers using third-party storage services must ensure that the third-party company has obtained a medical device business license.

Dealer License: If you are engaged in the import, export or distribution of medical equipment in South Africa, then you will need to apply for a dealer license, as these activities fall within the scope of a dealer's business. Dealers using third-party storage services must ensure that the third-party company has obtained the relevant license.

Wholesaler License: If you purchase medical equipment from local manufacturers or distributors in South Africa and then sell it to retailers, you will need to apply for a wholesaler license. The wholesaler license does not allow you to engage in the import or export business of medical equipment. A wholesaler can store products on behalf of approved distributors or manufacturers.

Registration Language

English.

Registration Flow, Cycle & Official Fee

1. Registration Flow

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2. Registration period and official fees

Registration period: Usually 1 to 3 months

Registration fee:

Manufacture Licence application fee: 25,200 lattrons

Distribution Licence application: The fee is 15,000 rand.

Wholesale Licence application: The fee is 15,000 rand.

Import Licence application: The fee is 15,000 rand.

Export Licence application: The fee is 15,000 rand (charged only when the target market is another African country)

Registration certificate application (Certification cost): The cost for each license is 3400 lattrons.

Application for amendment of an existing manufacturing, distribution, wholesale, import or export license (Application for the amendment to an existing licence to manufacture, distribute, wholesale, import or export): The fee is 5300 rand.

Label information

(1) The name of the medical device or the trade name;

(2) Product description and intended use;

(3) Product catalogue code, batch number, serial number, validity period (if applicable);

(4) For accessories, the serial number can be replaced by the control number, and for software, the version number can be used as a substitute; if the expiration date is not specified, the production date should be indicated.

(5) Name and business address of the manufacturer;

(6) The name and business address of the certificate holder;

(7) If applicable, indicate that the medical device contains or comprises controlled substances or biological materials;

(8) Indicate the specific storage or handling conditions applicable;

(9) If medical devices are supplied in a sterile state, their sterile status should be indicated, and the sterilization method (if applicable) should also be specified.

(10) If applicable, indicate the net content, expressed in terms of weight, volume, quantity, or any other terms that can accurately represent the contents of the package.

(11) Warnings or preventive measures to be applied in certain circumstances;

(12) In appropriate circumstances, it should be indicated that the medical device is: (i) for single-use; (ii) for clinical trials or pre-market clinical performance studies; (iii) for non-clinical research, teaching or testing purposes; (iv) for display or demonstration purposes; (v) for in vitro diagnosis or laboratory development of tests; and (vi) in relevant cases, indicate "for professional use only", or "for patient contact testing", or "immediate testing" or "self-testing".

三、FAQ

Q: How long is the South African Medical Device Registration Certificate valid?

A: Five years.

Q: Can the South African medical device registration certificate be renewed when it expires? How to operate?

A: Sure. The manufacturer must apply for renewal at least 90 days before the expiration date of the certificate and pay the renewal fee.

Q: What supporting documents are required when submitting a license application?

A: Manufacturers and distributors are required to submit quality manuals, and manufacturers and distributors are also required to submit ISO 13485 certification when required. Different types of applicants (such as wholesalers) also need to submit corresponding specific documents, such as landlord documents.

Q: Can a company apply for different types of licenses at the same address?

A: Yes.

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