Over the last few months, there have been numerous new entrants into the MedTech space. These companies have mainly been focusing on supporting the nation’s COVID-19 efforts through PPE and other COVID-19 related products.
SAMED has received several reports that there are companies trading medical technologies without a SAHPRA Medical Device Establishment License. By law, all companies trading medical device (with the exception of certain Class A non-sterile, non-measuring devices), are required to have a valid Medical Device Establishment Licence issued to them by the South African Health Products Regulatory Authority. The devices are also required to be listed on that license as categorised by their risk classification.
Any companies are trading medical technology without this license are trading illegally and it is essential that they are reported to SAHPRA for further investigation.
SAHPRA has published a list of licenced companies, under documents at the bottom of their medical devices page, which you can use to first check if the company has a Medical Device Establishment License before sending a report. Please ensure that you visit the SAHPRA website to obtain updates as this is an evolving list.
Please report unlicensed companies directly to SAHPRA by emailing: mokgadi.fafudi@sahpra.org.za
