South Africa SAHPRA's Med Dev Guidance: Updated Q&A-Guide to Licensing Medical Device Establishments
- Sharan Murugan
- 20 hours ago
- 2 min read
In South Africa, the licensing of medical device establishments is a vital step to ensure compliance with national health regulations and to guarantee the safety and performance of medical devices in the market. To assist manufacturers, importers, distributors, and wholesalers, the South African Health Products Regulatory Authority (SAHPRA) has released an updated guideline on Questions and Answers: Licensing of Medical Device Establishments (Version 4, May 2025).
This detailed and user-friendly document provides clarity on the submission process, renewal applications, required documentation, applicable fees, and key operational expectations for all stakeholders in the medical device supply chain. In this blog, we summarise and interpret the key sections of this guideline, offering a practical and comprehensive overview for industry professionals.
The guideline is designed to supplement SAHPRA's core licensing documentation, answering frequently asked questions from applicants. It aims to improve the efficiency and clarity of the licensing process and applies to manufacturers, distributors, and wholesalers of medical devices and in vitro diagnostics (IVDs).
There are three main types of medical device establishment licences:
Manufacturer’s Licence (GLF-MD-06A): Required for those involved in manufacturing, packaging, labeling, servicing, or refurbishing medical devices. This licence also covers import, distribution, and export activities.
Wholesaler’s Licence (GLF-MD-06B): For establishments procuring devices from local sources and selling to retailers. This licence does not permit import or export.
Distributor’s Licence (GLF-MD-06C): For importers, exporters, or distributors. Third-party storage providers must also be licensed.
Renewal applications must be submitted at least 90 days before expiry and follow similar documentation requirements to new applications.
Renewals cannot include major amendments, such as a change of company name or activities. If renewal is attempted less than six weeks before expiry or after the licence expires, a new application is required.
Submission Process and Documentation
The application process is digital and begins on the SAHPRA website. Applicants must:
Download the relevant application form in Microsoft Excel format.
Submit a cover letter on company letterhead, signed by the authorised representative, addressed to the CEO, and listing all annexures.
Include supporting documents such as:
The completed application form (Excel and signed PDF)
Curriculum Vitae of the authorised representative
Quality Manual (for manufacturers/distributors) or Site Master File (for wholesalers)
Proof of payment for the application fee
ISO 13485 certification (for COVID-19-related products)
Ensure all documents are initialed and signed as required
Applications involving COVID-19-related products (e.g., PPE, test kits, ventilators) require additional documentation, including ISO 13485 certification. Business-as-usual applications pertain to all other medical devices and follow standard requirements.
A Quality Manual is mandatory for manufacturers and distributors, detailing the quality management system, personnel, facilities, and procedures. Wholesalers must submit a Site Master File outlining their operational controls. The guideline references the official fee schedule available on the SAHPRA website. Licences must be renewed periodically, with a separate process and documentation requirements for renewals and amendments.
By following the outlined procedures, manufacturers, distributors, and wholesalers can confidently navigate the regulatory landscape, reduce delays, and ensure seamless access to the market.
📄 Download the Full Guideline (Version 4, May 2025):