Medical Device Registration in South Africa

South Africa is one of the most developed healthcare markets in Africa and serves as a key hub for the supply of medical devices to neighboring African countries. The South African Health Products Regulatory Authority (SAHPRA) is the national regulatory body responsible for overseeing medical devices in the country. SAHPRA regulates and licenses establishments involved in the manufacture, import, and distribution of medical devices and manages the registration of both In Vitro Diagnostic (IVD) and non-IVD medical devices. 

South African Health Products Regulatory Authority

Medical device registration in South Africa is governed under the Medicines and Related Substances Act, 1965. All manufacturers, importers, and distributors must comply with the regulatory requirements outlined in this legislation to market medical devices legally in the country. 

As an experienced medical device regulatory consultant, Operon Strategist provides expert guidance throughout the SAHPRA registration process. We assist clients in understanding regulatory obligations, preparing compliant documentation, and navigating the approval pathway to achieve timely and successful medical device registration in South Africa. 

Medical Device Establishment License

The type of establishment license required in South Africa depends on the nature of your medical device activities. For example, companies involved in packaging, labeling, or servicing medical devices must apply for a Medical Device Manufacturing License. Businesses engaged in the import or export, or distribution of medical devices are required to obtain a Distributor’s License.

All SAHPRA medical device establishment licenses are valid for five (5) years.

Applicants may apply for one of the following three types of establishment licenses:

  • Manufacturer
  • Distributor
  • Wholesaler

The Medical Device Establishment License enables SAHPRA to maintain accurate records of:

  • All medical device manufacturers operating within South Africa
  • All importers, distributors, and wholesalers of medical devices in the country

Additionally, the license supports the proper classification of medical devices and In Vitro Diagnostics (IVDs) based on their risk classification and intended use, ensuring effective regulatory oversight and patient safety.

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: 

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