SAHPRA License Application for Medical Device Manufacturers in South Africa

For medical device manufacturers looking to operate in South Africa, obtaining a license from the South African Health Products Regulatory Authority (SAHPRA) is a critical regulatory requirement. The SAHPRA License Application for Medical Device Manufacture (Document No. GLF MD 06A, Version 5, updated 17 September 2025) governs both the application and renewal process for manufacturers under the Medicines and Related Substances Act, 1965 (Act 101 of 1965). 

Compliance with these regulations ensures that medical devices and in vitro diagnostics (IVDs) are manufactured to meet safety, quality, and regulatory standards before entering the South African market.

Document Overview

The SAHPRA license application is a formal document that provides a structured framework for both new and renewing medical device manufacturers. It ensures that all necessary information is provided to assess compliance with safety, quality, and regulatory requirements. 

The application is formally titled License Application Medical Device Manufacture, categorized as an Application Form for Medical Devices & IVDs, and is currently at Version 5, updated on 17 September 2025.

Purpose

The license is required for the application or renewal of a medical device or IVD manufacturing license in South Africa. Its purpose is to regulate and monitor manufacturing activities, ensuring that devices meet rigorous quality and safety standards before they reach the market. 

Obtaining this license also provides assurance to customers, regulatory bodies, and other stakeholders that the company operates in compliance with South African law.

Applicant / Company Information

The application begins with the applicant or company information. Applicants must provide the company’s full legal name, physical and postal addresses, and accurate contact details. 

This information must match supporting documentation such as business registration certificates or incorporation documents. Inconsistencies at this stage can delay processing, so careful attention to detail is essential.

Manufacturing Site(s)

Applicants are required to list all manufacturing sites where medical devices or IVDs are produced. SAHPRA may request proof of ownership or lease for each facility, as well as maps or floor plans that demonstrate compliance with Good Manufacturing Practice (GMP) standards. 

Maintaining accurate and up-to-date site documentation is critical for ensuring a smooth review process.

Device(s) to be Manufactured

The application requires detailed information about the devices to be manufactured, including classification, description, and intended use. Manufacturers should cross-reference ISO standards and technical documentation to demonstrate compliance. 

Clear, thorough descriptions enable SAHPRA to evaluate product safety and performance, and ensure that the manufacturing processes meet international standards.

Quality Management System

A strong Quality Management System (QMS) is essential for compliance. Applicants must indicate whether they hold ISO 13485 certification or an equivalent standard, provide valid certificates, and clarify the scope of their QMS coverage. 

A robust QMS demonstrates that procedures, controls, and documentation practices are in place to maintain consistent product quality.

Personnel / Key Responsible Persons

Applicants must list key personnel, including technical, regulatory, and quality officers responsible for manufacturing and compliance oversight. SAHPRA may request CVs or qualification certificates to confirm that staff have the required expertise. 

Having qualified personnel ensures proper oversight of critical operations, process validation, and regulatory compliance.

Processes & Validation

The processes and validation section requires a summary of critical manufacturing steps, risk assessments, and validation activities. For devices requiring sterilisation, detailed sterilisation protocols and validation procedures must be included. 

Proper documentation ensures that SAHPRA can assess manufacturing safety and effectiveness, reducing the risk of non-compliance

Supporting Documents Checklist

A complete set of supporting documents must accompany the application. 

This includes:

• Compliance certificates
• Safety data
• Previous licences
• And any other relevant documentation

Clearly indexed and organised attachments facilitate review and prevent delays caused by missing or unclear documents.

Declaration & Signature

The application must be signed by an authorised company representative, with names and dates matching official records. For renewal applications, applicants must reference the existing licence number and provide a history of compliance with SAHPRA inspections or audits. 

Demonstrating a strong compliance history can streamline renewal approvals.

Legal Basis & Regulatory Context

Licensing is governed under Sections 22C and 22D of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Section 22C authorises SAHPRA to regulate the manufacture, import, and export of medicines and medical devices, while Section 22D empowers the authority to issue, refuse, suspend, or revoke licences. 

Understanding this regulatory framework is essential to operate legally and mitigate the risk of penalties.

Contact & Support

For general enquiries about the licence application process, companies can contact enquiries@sahpra.org.za. Manufacturers, particularly international companies new to South Africa, are advised to consult with regulatory experts to ensure that applications are complete and compliant. 

Preparing thoroughly and submitting well-documented applications can prevent delays and facilitate timely approval.

Final Thoughts

Obtaining a SAHPRA licence is more than a regulatory requirement, it is a key step in ensuring that medical devices and IVDs are manufactured safely and consistently. By understanding the application process, completing all sections thoroughly, and maintaining high-quality standards, manufacturers can secure licensure efficiently and contribute to delivering safe, reliable medical devices to the South African market.