Notification of an Update to the Product List(s) of a Medical Device Establishment Licence

1.1 On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101 of 1965; the “Act”), to include the regulation of medical devices.

1.2 In terms of Section 22C(1)(b) of the Act– the Authority may, on application in the prescribed manner and on payment of the prescribed fee, issue to a medical device or IVD establishment, manufacturer, wholesaler or distributor of a medicine, scheduled substance, medical device or IVD a licence to manufacture, import, export, act as a wholesaler of or distribute, as the case may be, such medicine, scheduled substance, medical device or IVD upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the Authority may determine.

1.3 The regulations relating to medical devices (Regulation No 1515 published in Government Gazette No 40480 on 9 December 2016), published by the Minister of Health in terms of section 35(1)(xxvii) of the Act, make provision for the licensing of medical device establishments.

1.4 Regulation 5(7) of the Regulations Relating to Medical Devices and In-Vitro Diagnostic Medical Devices (IVDs) makes provision for the amendment of a medical device establishment licence. A licensee must notify the Authority in writing of any changes to any of the particulars furnished in the application or entered in the register that occur after the licence has been issued.