South Africa Medical Device Regulation

Regulatory Authority

South African Health Products Regulatory Authority (SAHPRA) The South African Health Products Regulatory Authority (SAHPRA) is an entity of the National Department of Health, created by the South African government to ensure that the health and well-being of human and animal health are at its core. SAHPRA is a Schedule 3A public entity that is responsible for:

the regulation of health products intended for human and animal use;
the licensing of manufacturers, wholesalers, and distributors of medicines and medical devices; radiation emitting devices and radioactive nuclides;
the conduct of clinical trials in a manner that is compatible with the national medicine policy.

The Medical Devices Unit of SAHPRA regulates the licensing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality, and performance.

Link for Regulatory Authority

https://www.sahpra.org.za/medical-devices/#:~:text=The%20medical%20device%20unit%20of,level%20of%20safety%2C%20quality%20and

Legislation

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

Local Regulation

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

Classification of Medical Devices

Class A, B, C and D

Registration Of South Africa Medical Device Registration

The registration process for medical devices is still in development. A Registration Call-Up Plan will be published to inform stakeholders of the phased approach in which medical devices will be called up for registration. This plan will specify the type and class of medical devices that will be prioritized and called up sequentially. SAHPRA will implement reliance pathways in the registration of medical devices based on the verification of registration of medical devices in other recognised jurisdictions including Australia, United States, European Union, Brazil, Canada, Japan and or pre-qualification of IVDs by the World Health Organization.

Process Flow

Listing or Registration Requirements

Appoint an authorized representative (AR) in South Africa. AR submits application to the Council.
Prepare necessary documentation including Conformity Assessment Body (CAB) and Declaration of Conformity (DoC).
Demonstrate the device meets Essential Principles
Demonstrate conformity by applying to a Conformity Assessment Body (CAB) or International Notified Body for the CA certificate.
If the application is successful and CA certificate is granted the RA will now prepare Declaration of Conformity (DoC).

Documents Required

Completed application form 41BM-1(IMP)
Color brochure (including technical specifications); and
Letter of appointment as authorized representative of the original manufacturer; and
Copy of the EC Certificate(s) issued by a recognized Notified Body to the original manufacturer in terms of EC Directive 93/42/EEC or 90/385/EEC (whichever one is applicable); and
Copy of the EC Declaration of Conformity issued by the original manufacturer in terms of EC Directive 93/42/EEC or 90/385/EEC (whichever one is applicable).

Registration Timeline

SAHPRA License:

Regular pathway based on the actual experience: 6-8 weeks
Radiation Control License: 30 days
Official published timeline for expedited regulatory pathway during COVID-19 pandemic: 10-15 working days.