SAMED has send submissions on the Health Department’s updated draft Medical Device Regulations and the draft SAHPRA fees for health products that were due by 24 November and 3 November 2023 respectively.
The key message in SAMED’s comments is that these regulations must be amended in order to reduce significant risks to all stakeholders across the healthcare system – medtech suppliers, procurers and users, healthcare providers and patients alike.
The product registration process is due to commence soon, and by staying so closely involved with these regulatory developments, SAMED is striving to prevent registration delays and technologies being either temporarily or permanently removed from the market.
We believe that this effort needs member and stakeholder support, giving all of us a valuable opportunity to ensure that the final regulations are sustainable, fit-for-purpose and that they do not compromise the availability of and access to life-improving and lifesaving medtech.
An example of the regulations that require careful consideration is how will the registration of the same medical device by multiple distributors be handled. It is redundant and inefficient for the same technical information to be submitted multiple times to SAHPRA by different suppliers and it might also create the risk of differing outcomes.