Chapter 1 South African SAFHRA Administration Information Abstract

1. Administration and Abstract

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

2. 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.]

3. 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:

4. Entry Requirements

(1) South African representative: The South African representative shall be a natural person residing and conducting business in the Republic of South Africa, able to represent manufacturers, importers, distributors, wholesalers, retailers or service providers of medical devices or IVD products in the Republic of South Africa for product registration, compliance affairs, etc., and apply for and hold relevant licenses or registration certificates in their name. The registration application must include the details of the authorized representative in South Africa.

(2) Registration documents: Official application form, specification, label, conformity assessment certificate (CE certificate/certificate issued by other recognized CAB bodies), quality system certificate, the basic principles of safety and performance meeting compliance, etc.

(3) An application must be made for each individual medical device or IVD, group or series of medical devices or IVDs or modifications thereof (as determined by the Commission).

(4) If the medical device or IVD applied for registration has been registered with a regulatory authority outside the Republic of South Africa, a certificate of registration is required.

5. Registration Language

English.

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Cycle & Official Fee

Registration cycle: Usually 1-3 months.

Registration fees: South African SAOHRA does not charge for official fees.

Chapter 3 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?

A5: Yes.