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SAHPRA Head Office Building A Loftus Park 2nd Floor South African Kirkness Str Health Products Arcadia Regulatory Authority 0083 COMMUNICATION TO STAKEHOLDERS Issue No.: MD102025/26 21 January 2026 Amendment of a Medical Device Establishment Licence INTRODUCTION 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 In-Vitro Diagnostic (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. • Chairperson: Dr Thapelo Motshudi • Vice-Chairperson: Prof Glenda Gray • Dr Alfred Kgasi • Dr Chevon Clark • Dr Johanna Gouws • Dr Tobeka Boltina • Ms Mmatebogo Nkoenyane • Mr Anthony Ngcezula • Prof Rajesh Mahabeer • Mr Nkosenhle Ngongoma • Mr Moses Moselekwa CEO: Dr Boitumelo Semete-Makokotlela

SAHPRA South African Health Products Regulatory Authority SAHPRA Head Office Building A Loftus Park 2nd Floor Kirkness Str Arcadia 0083 1.4 Section 5(7) makes provision for the amendment of a medical device establishment licence. A licensee must notify the Authority in writing of a change to any of the particulars furnished in the application or entered in the register, which occurs after the issue of the licence 1. POSITION TAKEN BY SAHPRA 2.1 Licensees are required to make an application for the amendment of a medical device establishment licence in the event of a change in any of the following: a) Particulars of the licence holder. b) Class and/or category of medical device manufactured/imported/distributed/ exported/ wholesaled for which the approved licence is not authorised. c) Particulars of personnel responsible for operation on the premises on behalf of the licence holder, including the authorised representative or person(s) responsible for the control of manufacture/import/distribution/export and quality control. d) Any change in activity or special storage conditions of the medical device(s) manufactured/imported/distributed/exported/wholesaled that reflects on the approved licence. 2.2 A fee is payable for an amendment if changes are made as per section 2.1 according to the latest gazetted fees. 2. Submission to the authority 3.1 Submission of an application to the Authority for an amendment of a medical device establishment licence must include the following: a) A cover letter, addressed to the CEO and marked for the attention of the Medical Device Unit, with the details of the proposed amendment to the current approved licence. • Chairperson: Dr Thapelo Motshudi • Vice-Chairperson: Prof Glenda Gray • Dr Alfred Kgasi • Dr Chevon Clark • Dr Johanna Gouws • Dr Tobeka Boltina • Ms Mmatebogo Nkoenyane • Mr Anthony Ngcezula • Prof Rajesh Mahabeer • Mr Nkosenhle Ngongoma • Mr Moses Moselekwa CEO: Dr Boitumelo Semete-Makokotlela

SAHPRA Head Office Building A Loftus Park 2nd Floor South African Kirkness Str Health Products Arcadia Regulatory Authority 0083 b) An updated and complete application form in Microsoft Excel format, i.e., using the most recent version of the application form published by SAHPRA. c) An updated Microsoft PDF version of the licence application, with each page initialled and the last page signed by the authorised representative. d) Proof of payment for an amendment as per the published gazetted fees. e) An updated curriculum vitae (CV) of the authorised representative. f) An updated quality manual (manufacturer/importer/distributor) or site master file (wholesaler). g) Acopy of the current approved medical device establishment licence. h) A valid ISO 13485:2016 certificate in the name of the South African licensed medical device establishment and at the same address (if available) from a conformity assessment body (CAB) recognised by SAHPRA (ISO 13485 Certificate as a prerequisite for the approval of a Medical Device Establishment Licence - SAHPRA) Note: Any additional information/documents may be requested by the Authority. 3.2 An application for a licence amendment must be submitted via email to mdadmin@sahpra.org.za, the email subject: “Amendment to the manufacturer/distributor/wholesaler Licence [Licence no] of [Company name]”. Boitumelo Semete-Makokotlela SIGNIFLOW Dr Boitumelo Semete-Makokotlela SAHPRA Chief Executive Officer (CEO) * Chairperson: Dr Thapelo Motshudi • Vice-Chairperson: Prof Glenda Gray • Dr Alfred Kgasi • Dr Chevon Clark • Dr Johanna Gouws • Dr Tobeka Boltina • Ms Mmatebogo Nkoenyane • Mr Anthony Ngcezula • Prof Rajesh Mahabeer • Mr Nkosenhle Ngongoma • Mr Moses Moselekwa CEO: Dr Boitumelo Semete-Makokotlela