Speaking at the SAMED 2019 conference on 30 July, Andrea Julsing Keyter (Deputy Director, in charge of medical devices at the SA Health Products Regulatory Authority, SAHPRA) focused on the application process, licencing of establishments, guidelines, fees and product registration.

The local medical device regulations are following a similar approach like the one taken in Europe, Andrea said, underscoring SAHPRA’s efforts to harmonise regulations.

  • SAHPRA was on track to initiate the process for registration of medical devices and IVDs.
  • This would begin after SAHPRA completed the licensing of medical technology establishments (nl. Manufacturers, distributors and wholesalers) with the condition that all needed to have a valid license from 1 October 2019. Andrea indicated that SAHPRA has cleared outstanding backlogs with the processing of license applications.
  • Companies that have applied for amendments of licenses (for example, to change company name, address, contact details, authorised representative, product listing) need to obtain an amended license as well.

Andrea indicated that SAHPRA is hard at work to prepare the field for the product registration process:

  • It still has to publish updated regulations and fees, which would be available for comment, as well as recruit additional staff for the Medical Devices Unit.
  • The phased call-up plan for registration of devices will soon be published, providing details on the priority devices, such as HIV self-test kits and high-risk products.
  • It would soon launch an online registration portal (at www.sahpra.org.za).

SAMED greatly appreciates SAHPRA’s engagement during the conference. This will further improve the SAHPRA’s understanding of the industry’s issues and strengthen collaboration between the regulator and suppliers.

Furthermore, SAMED will continue to participate in the Medical Device Forum, a platform for engagement between SAHPRA and industry, established late 2018 and share up to date information with members via SAMED’s regulatory forums – announced on SAMED’s website.