09 Sep SAHPRA CONFIRMS BEDHEAD SERVICE SYSTEM IS A MEDICAL DEVICE
There are currently some misconceptions in the industry as to whether bedhead service systems are considered to be medical devices.
Examples of bedhead service systems can be found at: https://www.hutz.co.za/products/bedhead-service-systems/
The attached communication, dated 21 August 2019, issued by the South African Health Products Regulatory Authority’s (SAHPRA) Acting CEO, Portia Nkambule, confirms that a bedhead service system is a medical device.
As per the Medicines and Related Substances Act, 1965 (Act 101 of 1965), in the regulations relating to medical devices, all medical device manufacturers, importers, exporters, distributors and wholesalers are required to obtain a licence from the SAHPRA. The licence allows for the regulation and control of medical devices to ensure patients are protected against harmful or ineffective medical devices.
One of the mandatory licencing requirements is that the licensee is required to provide SAHPRA with a valid and acceptable certificate to a quality standard. Both Hutz Medical and Hutz Hospi-Tec are ISO 13485:2016 (Medical Devices: Quality Management Systems) certified and are holders of SAHPRA licences, which means that we have stringent processes and quality systems in place which provide our customers and patients with the assurance they deserve.
Are your suppliers compliant?