The new article highlights the aspects related to the process of applying for a medical device establishment license required to conduct operations with medical devices.
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The South African Health Products Regulatory Authority (SAHPRA), the regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the licensing of medical device establishments.
The guidelines structured as a questions-and-answers document provide additional clarifications regarding the existing regulatory framework, as well as recommendations to be taken into consideration by medical device manufacturers, distributors, and other parties involved in the manufacturing and supply of medical devices to ensure compliance with the applicable regulatory requirements.
The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Introduction
According to the guidance, the process of obtaining a Medical Device Establishment License involves various types and steps of applications, each catering to specific activities in the medical device sector.
This comprehensive guide outlines the procedures and requirements for different licenses, highlighting the nuances between COVID-19-related and business-as-usual applications.
Types of Licenses and Eligibility
First of all, the authority describes existing types of establishment licenses available in the country, namely:
- Manufacturer License
Required for such activities as packaging, labelling, servicing, or refurbishment of medical devices. This license covers manufacturing, import, distribution, and export activities. - Distributor License
Necessary for importing, exporting, or distributing medical devices. - Wholesaler License
This applies to those procuring medical devices from local manufacturers and selling them to retailers or distributors, excluding the right to import or export.
COVID-19 vs. Business-as-Usual Applications
According to the guidance, a specific approach should be applied concerning submissions intended to address the needs associated with the pandemic caused by Sars-CoV-2 (COVID-19).
- COVID-19 Applications
Include COVID-19-specific medical devices such as test kits, ventilators, PPEs, masks, thermometers, and oximeters. - Business-as-Usual Applications
Cover general medical devices, excluding the products specified for COVID-19 applications.
Application Documentation
The document also outlines the scope of documentation to be provided by the applicant, namely:
- Cover Letter
Prepared on company letterhead, signed by the authorized representative, and addressed to the CEO of the Medical Device Unit.
It should state the application’s purpose and include a list of annexures. - Annexures
Include the Licence Application, Proof of Payment, Curriculum Vitae of the Authorised Representative, Quality Manual/Site Master File, and other relevant documents based on the type of application. - Electronic Version
A completed license application in MS Excel or MS Word format, initialled on each page by the Authorized Representative.
Application Procedure
According to the document, the application procedure comprises the following steps:
- Online Submission
Visit the SAHPRA website, navigate to the “Health products” and “Medical devices” tabs, and select the appropriate application form. - Email Submission
Completed forms along with supporting documents should be sent to designated email addresses, depending on the type of application (COVID-19 related or business-as-usual).
Amendment Applications
The present guidance also describes the steps to be completed in case of changes to the application in question to be introduced by a respective amendment application. Key points:
- Process: Applicants should follow the same steps as the initial application but focus on the changes to the existing license.
- Notification vs. Amendment: Notifications involve minor updates not affecting the license class, while amendments include significant changes like address or contact details alterations.
Specific Aspects
The guidance also highlights certain specific aspects to be taken into consideration by the parties involved in operations with medical devices, such as:
- Screening Processes: Include administrative and technical screenings, where deficiencies must be addressed within specified timeframes.
- Review Periods: Expedited COVID applications are reviewed within 10-15 working days, while business-as-usual applications take 6-8 weeks.
- Amendments for Role Changes: If the Authorized Representative/License Contact Holder resigns, an amendment application is required.
- Incomplete Applications: In case of deficiencies, applicants are notified via email and given a deadline to respond.
- Classification Confirmation: Applicants should confirm the classification of their device on the SAHPRA website under the “Guidelines” section.
- Rejection Reasons: Applications can be rejected for reasons like a lapse in the review period, non-compliance, insufficient information, or incorrect/falsified information.
- Additional Documentation: For COVID-19-related products, additional documents like ISO 13485 certification, premarket registration evidence, SANS/NRCS certificates, packaging, labelling information, and instructions for use are required.
- Exemptions: Section 36 of the Medicines and Relates Substances Act allows for exemptions under specific conditions, facilitating a more flexible approach in certain circumstances.
Conclusion
In summary, the application process for a Medical Device Establishment License in South Africa is detailed and varies depending on the type of license and the nature of the products (COVID-19-related or not).
Applicants must carefully prepare their documentation, adhere to the specified procedures, and be mindful of the differences in application types, especially concerning COVID-19 products.
Timely and accurate compliance with these guidelines is crucial for successful application processing.
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