Atlas Copco has applied for licensing of its turnkey BeaconMedaes ISO 7396-1 accredited medical gas solutions portfolio to the South Africa Health Products Regulatory Authority (SAHPRA) in line with recent amendments to regulations relating to medical devices and in vitro diagnostics (IVDs).
In August 2016, the Registrar of the MCC issued guidelines for a licence to manufacture, import, export or distribute medical devices, initiating the first practical step towards medical device registration in South Africa. The publishing of ‘Regulations relating to medical devices and in IVDs’ by the Minister of Health in the Government Gazette on 9th December 2016 mandates all companies involved in import, export, wholesale, manufacture or distribution of Class B, Class C and Class D medical devices and IVDs to apply for licencing from the regulating authority in order to continue trading legally in South Africa.
In accordance with the licencing requirements, an authorised representative must be designated in the application together with providing particulars of the prospective holder of the certificate of registration. Any person residing and doing business in South Africa can make the application for registration.
