South African Health Products Regulatory Authority (SAHPRA)
Medical Device Registration in South Africa
South Africa stands as the most prosperous country on the African continent and holds a prominent position as a major provider of medical devices to neighboring African nations. The South African Health Products Regulatory Authority (SAHPRA) serves as the regulatory body overseeing medical devices within the country. SAHPRA is entrusted with the responsibility of regulating and granting licenses to establishments involved in medical device production, as well as overseeing the registration of a wide range of medical devices, including both In-Vitro Diagnostics (IVDs) and non-IVDs.
Medical device registration in South Africa is governed under the provision of the Medicines and Related Substances Act of 1965. All manufacturers, importers, and distributors must adhere to the rules and regulations laid down in the act to get medical device registration in South Africa. As a Medical device regulatory consultant, we can guide you in the right direction to get your medical device registered in South Africa.
Medical Device Establishment License
The type of license will depend upon your use. For example, if you are packaging, labeling, and servicing medical devices you must apply for a medical device manufacturing license. If you are distributing by importation/exportation of devices you must apply for a distributor’s license. The License validity is for 5 years.
One can apply for one of three types of establishment license:
- Manufacturer
- Distributor
- Wholesaler
The Medical Device Establishment Licence helps the SAHPRA in maintaining the record of:
- All the manufacturers of medical devices within the country;
- All the importers and distributors of medical devices within the country.
- Along with this, the Licence helps in classifying the medical devices and IVDs as per their risk assessment and intended use.
SAHPRA Medical Device Classification
Classification of medical devices is based on the intended use of the device or IVD, the level of risk to the patient or user, and the duration of use and exposure. The applicant should consider South African requirements while classifying the devices. Our team can assist you in classifying these devices to make it easy and simple for you.
Classification | Level of Risk |
Class A | Low risk |
Class B | Low- Moderate Risk |
Class C | Moderate –High Risk |
Class D | High Risk |
Medical Device Registration Process
The applicant must apply to a Medicine Control Council (MCC) for a manufacturing, import/export, or distributor license for medical devices or IVDs. In order to comply with the requirements of the Medicines and Related Substances Act of 1965, applicants selling medical devices and IVDs within the borders of South Africa are encouraged to submit an application for a license to import, export, distribute, or manufacture a medical device or IVD to the MCC (Act 101 of 1965).
Essential requirements
Apart from various technical documents and certificates, below are some crucial requirements for the successful registration of medical device:
- Foreign manufacturers need to appoint an Authorized Representative (AR) to obtain a license.
- AR must submit an application to the Medicines Control Council (MCC).
- Proof that your medical device adheres to all the essential principles.
Looking For Medical Device Regulatory Consultation?
Medical device manufacturers should seek assistance from medical device regulatory consultants as they provide services like device classification, QMS implementation, creation of technical files of necessary documents, and obtaining the required license for manufacturing/distributing medical devices.
How Can We Help You in Medical Device Registration in South Africa?
Operon Strategist, an exclusive worldwide regulatory partner, provides customized regulatory affairs consulting services in response to manufacturers’ growing issues over the new regulatory agency and its processes for successful registrations and approvals. In South Africa, Operon Strategist provides:
- Turnkey project consulting services
- Regulatory approval assistance For CE Marking, USFDA 510(k), CDSCO, SFDA, and EDA Approvals.
- QMS Implementation.
- Assistance in Design & Development documentation.
The team at Operon Strategist can provide the necessary medical device consulting to help ensure your successful registration of the devices and regulatory compliance. Feel free to speak with our experts for assistance with your project.
FAQs
What is the South African regulatory authority for health products?
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.
Who regulates medical devices in South Africa?
South African Health Products Regulatory Authority (SAHPRA) regulates medical devices in South Africa.
What is FDA in South Africa?
What is FDA in South Africa?
SAHPRA is the Regulatory Authority of South Africa, which is responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and radioactive nucleides