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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.: MD092025/26 21 January 2026 Notification of an Update to the Product List(s) 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 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. • 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 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. SUBMISSION REQUIREMENTS 2.1 Before the implementation of changes or updates to the details on a medical device establishment license, the license holder is required to make an application to SAHPRA to amend or update their medical device establishment license. This application is to be submitted via email to mdadmin@sahpra.org.za and may only be implemented after the approval outcome has been sent to the license holder. 2.2 In the event of a change in the list of products imported or manufactured, or exported in the application form submitted to the Authority, the licence holder is required to notify the Authority in writing of the changes to the product list, provided that no other information on the current issued licence will change. 2.3 The submission will be reviewed in accordance with the internal procedures and may be approved or rejected based on information requested and received by the Authority. If the proposed change affects the details of the issued licence such as: a) change in the name and details of the authorised representative or licence holder, b) change in the address of the organisation, c)addition or removal of a class of the medical device (including IVD) manufactured/imported/ exported/ distributed/ wholesaled, or • 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 e) particulars of personnel responsible for the supply chain and QA/QC, and activities, then the notification will be rejected, and the licence holder will be required to apply to amend the medical device establishment licence. 2.4 In the absence of a response from the authority or the outcome of the notification is not communicated within ten (10) working days following submission of the notification, the organisation may proceed with implementing the change. This is permissible only on the condition that the change does not constitute an amendment or otherwise affect the particulars reflected on the licence. Note: If the Authority determines that the submitted notification constitutes an amendment, the license holder or authorised representative will be requested to submit an amendment application. 2.5 An application fee will not be applicable upon submission of a notification, as noted in 2.2 above, to the Authority. However, a submission of an amendment application must be accompanied by the application fee. (For the amendment fees payable to the Authority, refer to latest fee guideline as published in the government gazette) 2.6 Submission of a Notification to the Authority to update the product list must include: 2.6.1 A cover letter signed and dated by the organisation’s authorised representative — for the attention of the Medical Device Unit. 2.6.2. A written declaration by the authorised representative indicating that the changes made to the product list(s) do not affect the class of medical device(s) for which the licence holder has been approved. 2.6.3. Completed the latest/updated version of the SAHPRA application form in Microsoft Excel format and PDF version (medical devices and in vitro diagnostics application forms - SAHPRA). 2.6.4. A copy of the current medical device establishment licence. 2.5.5. Confirmation (proof of payment) that the annual licence retention fees have been paid as per regulation 5(6) of regulations relating to Medical Devices and IVDs. 2.6.6. Any other supporting documents about the product(s) to be added or removed. • 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 2.6.7 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) 2.7 It should be noted that there are exceptions to the requirement for submitting notifications; these exceptions are at the discretion of the Authority. SAHPRA may exempt certain medical devices from the notification process—such as those intended for use during public emergencies in South Africa. If the change is exempt from the notification process, the license holder/authorised representative will be required to submit an amendment application, which is accompanied by an amendment application fee as published in the latest government gazette. 2.7 A notification of change to the product list, as noted in 2.2 above, must be submitted via email to mdadmin@sahpra.org.za , the email subject of the submission must state: Notification to update the manufacturer/importer/distributor/exporter/wholesaler Licence [Licence no] of [Company name]. Boitumelo Semete-Makokotlela SIGNIFLOW Dr Boitumelo Semete-Makokotlela Chief Executive Officer (CEO) SAHPRA * 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