Recently the medical body MCC has fallen away and been replaced by SAHPRA, a new regulatory body for Medical devices, medicines, cosmetics, foodstuff and related substances. SAHPRA is the only body with the power to register any new medical devices or medicines that wish to enter the market. Most importantly SAHPRA oversees periodic monitoring, evaluation and further re-evaluation to ensure continuous and improved safety, efficacy and performance of medical devices across South Africa.

How the New Medical Regulations Will Affect You

 For you as a South African, the new medical device regulations are a major advantage, as we will know that should we need to use a medical device they are registered, safe and in good running condition. Here are two important ways that the new medical device regulations will affect you, as a South African:

Compulsory Licensing & Registration of ALL Medical Devices

In South Africa, we have seen new regulations being implemented, this includes the four-tier, risk-based classification system for not only obtaining Medical device licencing but also licensing for the manufacture ring, importing and distribution of Medical Devices. The manufacturing, importing, exportation as well as the distribution, of medical devices, are subject to regulations, depending on the level of risk and the intended use of the device. As a citizen these licensing and registration regulations are a major advantage, by having these in place you are certain that every time you need to make use of a medical device, you can be sure it has been approved, licensed and registered by SAHPRA and is of perfect operational quality and not a further danger to your wellbeing.

Sales & Distribution of Medical Devices

SAHPRA has introduced a new act under which it states that a medical device cannot be sold by those who manufacturer them but only by bodies who are licensed and qualified. This Act also forbids advertisement of any medical devices by those who aren’t licensed and have the right expertise, this is to ensure all the prescribed requirements are met. All the regulations and restrictions are done to ensure only medical devices with the highest levels of safety, performance and quality are being sold to the public and to ensure that the right device is being sold for the right situation, ensuring your health and safety as the consumer.

Call Glenmed Today for All Your Medical Devices Needs

The introduction of SAHPRA is evidently a great step forward in the South African medical field, as it ensures citizens have access to only the safest devices when necessary. If you are needing a reliable medical device company, contact Glenmed today to learn what devices we offer and to receive the necessary training to operate them.