Overview on Medical Device Registration and Complaint Reporting regarding Medical Devices in South Africa
Updated On: 24/01/2024
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 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: Class A, B, C and D
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.
Process Flow
Listing or Registration Requirements:
Documents Required:
Registration Timeline: SAHPRA License:
Registration Fee:
License Validity: 5 Years
Special Requirements: All documents should be submitted in English
Complaints Relating to Medicine and Medical Devices:
https://www.sahpra.org.za/complaints-relating-to-medicine-and-medical-devices/
Who should make this communication:
When to make this communication: Before placing a medical device into the market.
How OMC Medical can assist you with the process
Why Choose Us
Contact us for free consultation: [email protected]
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.