On January 17, 2022, Dr Boitomello Semete wrote: “Due to the delay in accreditation of South African Conformity Assessment Bodies, the requirement to provide an ISO13485 certificate upon application for renewal of a medical device establishment licence is extended for a period of three (3) years from date of signing of the document and or until further communication is shared by SAHPRA.” (MD030)
The extension thus applied to companies whose licenses expire prior to 17 January 2025. Companies whose licenses expire thereafter are still required to meet the requirement prior to applying for a renewal.
The reason for this extension was that at the time, there were very few conformity assessment bodies which were both SANAS accredited or IAF affiliated AND recognized by SAHPRA to certify compliance with ISO13485 under South Africa Medical Device Regulations (Medicines and Related Substances Act 101 of 1965).
Today there are still only 10 conformity assessment bodies listed on the SAHPRA website to audit all medical device companies prior to the deadline.
Two thousand, two hundred and seventeen licenses have been issued by SAHPRA as of November 2023. Nine hundred and twenty-one Distributors, 631 Manufacturers and 575 Wholesaler licenses, of which only 1256 appear to be unique companies.
There is therefore a pent-up demand for certification for licenses issued in 2017 (114), 2018 (157), and 2019 (428) totaling 699 licenses. An additional 348 licenses were issued in 2020, which will require certification prior to them being renewed.
Implementing and certifying a quality management system is a daunting task for small and medium size businesses, which comprise most medical device companies. It takes time, energy, knowledge, and finance. All resources which medical device companies in South Africa don’t have an over-abundance of.
The question then is how does a medical device company obtain certification to remain compliant with the regulations? Well, we have some suggestions for you:
