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The South African Health Products Regulatory Authority (SAHPRA), a country’s regulating agency in the sphere of healthcare products, has published a questions-and-answers document dedicated to the licensing of medical device establishments.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations for  consideration by medical device manufacturers and other parties involved in operations with medical devices to ensure compliance thereto.

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.

The authority also reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.

Introduction to Medical Device Regulation in South Africa

The amendment to the Medicines and Related Substances Act of 1965, specifically Act 101 and its 14th amendment in 2015, established the framework for regulating medical devices in South Africa.

To assist the parties involved with complying with the relevant obligations, the authority outlines the key regulations to be taken into consideration, including:

– SAHPGL-MD-06: Guidelines for licensing to manufacture, import, export, or distribute medical devices and In Vitro Diagnostics (IVDs).

– 16.04: Licensing provisions for wholesalers of medical devices and IVDs.

– Position papers for amendments and classification guidelines (SAHPGL-MD-04).

– SAHPGL-MD-05: A quality manual for medical devices.

– Various application forms for licensing in the medical device sector.

Document Purpose and Scope

The document aims to provide a comprehensive Q&A format, addressing queries related to the licensing of medical device establishments.

It is designed as a dynamic supplement to the existing guidelines and regulations, and additional information can be sourced from the SAHPRA website.

In particular, the document answers the most important questions potentially raised by industry representatives concerning the establishment of licensing under the existing legal framework.

The scope of the guidance covers, inter alia, the aspects related to:

• Submission requirements (the approach to be followed when applying)
• Costs associated with the submission and the way they should be paid
• Supporting documentation to be provided by the applicant
• Cooperation between SAHPRA and other regulating agencies.

Terms and Definitions 

The document defines the most important terms and concepts used in establishment licensing. According to the document, understanding the regulatory framework necessitates familiarity with specific terms:

• Authorized Representative
  A resident of South Africa who represents manufacturers, importers, distributors, and others in the medical device sector, responsible for all aspects of the device, including compliance and safety.
  
• Classification
  A system for categorizing medical devices and in vitro diagnostic products (IVDs) based on risk as per the guidelines.
  
• Distributor
  Entities involved in importing, exporting, and selling medical devices or IVDs.
  
• In Vitro Diagnostic Medical Devices (IVDs)
  Devices used for diagnostic and monitoring purposes, derived from bodily specimens.
  
• Manufacturer
  According to the document, this concept covers a wide range of operations from design to refurbishing of medical devices or IVDs.
  
• Medical Device
  Defined broadly to include various instruments and apparatuses used in healthcare, excluding those that operate through chemical or pharmacological means.
  
• Quality Manual
  An overview document that details the quality management system in place, outlining policies, procedures, and controls to meet regulatory standards.
• Wholesaler
  A dealer who buys from manufacturers or distributors and sells to retailers.

Conclusion

In summary, the present Q&A document issued by SAHPRA provides a general overview of the regulatory requirements associated with applying for an establishment license in the context of related regulatory procedures.

The document outlines the key points to be taken into consideration by the interested parties to ensure compliance with the respective requirements set forth under the existing legal framework.

Source

https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf

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