Medical Devices

The medical device unit of SAHPRA regulates the licencing 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.

ADMINISTRATION

 

Licensing of Medical Device Establishments

 

An applicant may apply for one of three types of licences for medical device establishments: manufacturer (manufacture, pack, label, service, import, export), distributor (import, export, distribute) and wholesaler (storage, transportation, delivery). A call up notice, published in Government Gazette No. 40637, on the 24 February 2017, requested all manufacturers and distributors of medical devices to apply for a SAHPRA licence within 6 months of publication of said notice and wholesalers were required to apply within 12 months of said notice.

 

Currently, a transitional arrangement allows for the use of an acknowledgement letter received from SAHPRA, in lieu of a medical device establishment licence, on submission of a licence application, so as to facilitate trade and ensure continuation of business and access to medical devices whilst the SAHPRA licensing process developed. As of the 31 March 2020 the use of an acknowledgement letter in lieu of a medical device establishment licence will not be permitted.

 

No medical device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA medical device establishment licence.

 

Note 1: Providing evidence of a valid SAHPRA medical device establishment licence will be required to be eligible to bid for National and Provincial tenders.

 

Note 2: A manufacturer, distributor, wholesaler of a non-sterile, non-measuring Class A medical device is exempt from licencing, as per the SAHPRA position statement 9.106 “Class A medical devices”.

 

Medical device establishments who have applied for a SAHPRA licence must appoint an Authorised Representative who must be a natural person based in South Africa. One representative is required for each site where the company carries out its business. The representative is responsible for adherence to the law, regulations and guidelines.

 

As part of the application for a SAHPRA medical device establishment licence a company must list all the medical devices that it manufactures, distributes, or wholesales. The application includes a declaration regarding the status of the quality management system in place in the company. Upon renewal of the SAHPRA licence, manufacturers and distributors will have to provide evidence of ISO 13485 certification for the company by an accredited conformity assessment body.

 

Registration of Medical Devices

 

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 prioritised 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.

 

Fees

 

The current medicine fee structure for licencing of establishments is adopted for licencing of medical device establishments. 

 

FAQs

 

PROCESSES

 

How to apply for a licence for a medical device establishment

 

LEGISLATION

 

ACT

 

Medicines and Related Substances Act, 1965 (Act 101 of 1965)

 

REGULATIONS

 

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

COMUNICATION TO INDUSTRY

Introduction:

MD001 – Regulatory Requirements for Medical Devices COVID-19 v2 – 22072020

MD002 – Regulatory Requirements for Serological Test Kits v2 – 22072020

MD003 – Testing for COVID-19 v1 – 22072020

MD004 – EXTENSION – Use of Acknowledgement Letter in Lieu of Licence v1 – 31032020

MD005 – Expedited Regulatory Pathways for Medical Devices v1 – 22072020

MD006 – Laboratory Testing and Use of COVID-19 Serological Test Kits v1 – 22072020

MD007 – Specifications Serological Test kits v2 – 22072020

MD008 – ISO Standards for Medical Devices and Protective Clothing v1 – 22072020

MD009 -Alternative_Regulatory_Licensing_Requirements_Alcohol-based_sanitisers v1 – 03072020

MD010 – Regulatory Requirements, Technical Specifications, Licence Conditions and Authorisation for Use of Unregistered Rapidly Developed Invasive and Non-Invasive Ventilators for Covid-19 v1 – 26052020

MD011 – Licence Conditions for COVID-19 Serological Test Kits v1 – 22072020

MD012 – Notice of Contravention of Act 101 of 1965 v1 – 22072020

MD013 – Process Flow Locally Manufactured COVID-19 Test Kits v1 – 22072020

MD014 – Regulatory Requirements for Molecular Test Kits v1 – 22072020

MD015 – Process Flow Imported COVID-19 Test Kits v1 – 22072020

MD016 – Conditions of Use COVID-19 Serological Test Kits v1 – 22072020

MD017 – Technical Review Application COVID-19 Molecular Test Kits v1 – 22072020

MD018 – Specifications Molecular Test kits v1 – 22072020

MD019 – Processing of licence applications v1 – 22072020

MD020 – Certificate of Free Sale_v2 22072020

MD021 – Use SARS CoV-2 Antibody Tests NDOH Guidance v1 – 20082020

MD022 – Application_Clinical_Evaluation_Medical_Device_IVD_v1 – 01.09.2020

MD024: Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits

MD025_Alternative licensing and regulatory pathway for masks_September2020_vF

List of Approved Antigen tests spreadsheet 06102020