Guideline for Classification of Medical Devices and IVDs

This guideline is intended to provide recommendations to interested persons wishing to submit applications for the licensing of manufacturers, distributors and wholesalers, and registration of medical devices and IVDs. It represents the Authority’s current thinking on the safety, quality and performance of medical devices and IVDs. It is not intended as an exclusive approach. The Authority reserves the right to request any additional information to establish the safety, quality, and performance of a medical device or IVD in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used but these should be scientifically and technically justified.

The Authority is committed to ensuring that all registered medical devices and IVDs will be of the required quality, safety and performance. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications. Guidelines and application forms are available from the office of the Chief Executive Officer and the website.

NOTE: This guideline presents the classification rules for a Medical Device or IVD and should be read in conjunction with the Medicines and Related Substances Act, 1965 (Act 101 of 1965), and the Regulations to this Act.