This year marks five years since the implementation of Medical Device Establishment Licences and as such, many licences are now due for renewal. In February, the South African Health Products Regulatory Authority (SAHPRA) issued a communication to industry on the processes that need to be followed for licence renewal.
It is essential that medtech companies apply for licence renewal at least 60 days in advance of expiry to ensure that the new licence is issued prior to the expiry and the company is not barred from trading. Members can apply in advance of the 60-day period in order to ensure compliance with processes as outlined by SAHPRA. SAHPRA is likely to take a hard stance on companies who fail to renew their licence in time and this could jeopardise the company’s sustainability as trade will be prohibited until the new licence is issued.
As renewals and amendments cannot be processed simultaneously, we recommend that where possible, companies hold off on amendments to avoid waiting for the amendment to be processed so that they can submit for renewal. Delays on amendments may result in delays with licence renewal and an amendment will not be granted on an expired licence. Companies can do a listing update with the renewal as long as it falls within existing classifications on the current Medical Device Establishment Licence.
We encourage medtech companies to ensure that they submit their renewals at least 60 days prior to the expiry and retain proof of submission and follow up regularly with the SAHPRA until the new licence has been issued.