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68 No. 40480 GOVERNMENT GAZETTE, 9 DECEMBER 2016 4. Transmission of medical devices or IVDs through the Republic (1) Medical devices and IVDs that are transmitted through the Republic must- (a) while in the Republic, be stored in a bonded warehouse which is registered with the Council; and (b) not be manipulated while in the bonded warehouse unless authorised by the Council. (2) A bonded warehouse referred to in sub-regulation (1) must comply with the specified storage conditions determined by the Council. 5. Licence to manufacture, import, export or act as a distributor or wholesaler of medical devices or IVDs (1) A manufacturer, wholesaler or distributor referred to in section 22C(1)(b) of the Act must- (a) prior to commencing business- (i) apply to the Council for- (aa) a manufacturer licence to manufacture, import or export medical devices or IVDs; or (bb) a distributor licence to import, export and distribute medical devices or IVDs; or (cc) a wholesale licence to act as wholesaler of medical devices or IVDs; (ii) appoint and designate an authorised representative who must reside in South Africa- (aa) be responsible to the Council for compliance with the Act; and (bb) control the manufacturing, distribution, wholesaling and the sale of medical devices or IVDs. (b) submit to the Registrar an application for a licence, on a form approved and provided by the Council; (c) as part of the application, provide acceptable documentary proof of- (i) the particulars of the owner of the business; (ii) the particulars of the authorised representative; and (iii) certification to a Quality Management System for medical devices and IVDs as determined by the Council; This gazette is also available free online at www.gpwonline.co.za

STAATSKOERANT, 9 DESEMBER 2016 No. 40480 69 (d) specify, as determined by the Council, the medical devices or IVDs or group or family of medical devices or IVDs to be manufactured, imported, exported or distributed and sold; and (e) pay the application fee. (2) The Registrar may give the person referred to in sub-regulation (1) written notice to, within a reasonable time as specified in the notice, furnish the Council with such additional documentation or information as the Council may require. (3) The Council may, where applicable, inspect the business premises specified in the application. (4) If the Council is satisfied that- (a) the person referred to in sub-regulation (1) complies with the prescribed requirements; (b) the application for a licence- (i) to manufacture, import or export medical devices or IVDs; or (ii) to act as a distributor; or (iii) to act as a wholesaler of medical devices or IVDs complies with the prescribed requirements; and the authorised representative is able to provide certified evidence of certification to a Quality Management System as determined by Council, the Council must approve, with or without conditions, the application and issue the person with a licence. (5) The Registrar must- (a) keep a separate register for each of the categories of licensees referred to in sub-regulation (1)(a)(i); and (b) enter the licence number, the name of the licensee and his or her physical and postal addresses, in the register. (6) Despite the period of validity of the licence, the licensee must pay the annual fee for continued registration as determined by the Council. (7) A licensee must notify the Registrar 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. This gazette is also available free online at www.gpwonline.co.za

70 No. 40480 GOVERNMENT GAZETTE, 9 DECEMBER 2016 (8) An entry into the register which is proved to the satisfaction of the Council, to have been made in error or through misrepresentation or in circumstances not authorised by the Act, may be removed from the register. (9) A person in respect of whom an entry has been removed as contemplated in sub-regulation (8), must be notified of the removal and a certificate issued in respect of the registration in question must be considered to be cancelled as from the date on which notice has been given. (10) The Council may, subject to sub-regulation (11), direct the Registrar to remove the name of a licensee from the register if - (a) the licensee does not comply with the Act or the conditions of a licence; (b) the authorised representative fails to control the manufacturing or distribution, wholesaling or sale of the medical devices or IVDs; or (c) the licensee fails to furnish written reasons within the period stated in the notice referred to in sub-regulation (11). (11) Before directing the Registrar to remove the name of a licensee from the register, the Council must- (a) give notice to the licensee of its intention to remove the name of the licensee from the register and to close the licensee’s business; and (b) invite the licensee to furnish written reasons, within 21 days of the notice, why the licensee’s licence must not be removed from the register and the business closed. 6. Period of validity of licence and renewal of licence (1) A licence issued in terms of regulation 5 is valid for a period of five (5) years from the date of issue. (2) A licence referred to in sub-regulation (1) may be renewed by application to the Council. (3) An application for the renewal of a licence must - (a) contain at least the information or documentation referred to in regulation 5(1)(c), as the case may be; (b) be accompanied by the prescribed fee; and (c) be made at least 90 days before the expiry of the existing licence. This gazette is also available free online at www.gpwonline.co.za

STAATSKOERANT, 9 DESEMBER 2016 No. 40480 71 7. Appeal against decision of Council (1) A person aggrieved by a decision of the Council may, as contemplated in section 24 of the Act, lodge an appeal against the decision, in writing, within 30 days of being notified of the decision of the Council. (2) Notice of the appeal must be submitted to the Chairperson of the Council, for attention the Registrar, Medicines Control Council, Private Bag X828, Pretoria, 0001 (3) The notice referred to in sub-regulation (2) must set out clearly and succinctly the basis for the appeal. (4) The Registrar must, within 30 days of receipt of a notice of appeal, in the absence of legal representatives, meet with the appellant to try and resolve the matter. (5) If the matter is not resolved as contemplated in sub-regulation (4), the appellant may, within 30 days of being notified by the Registrar of the failure to resolve the matter, and upon payment of the prescribed fee, request the Minister to convene an appeal committee. (6) The appeal committee - (a) must determine the procedure for its hearings; (b) may, if it considers it necessary, call for oral evidence or argument or summon any person who- (i) in its opinion may be able to give information concerning the subject of the appeal; or (ii) it believes has in his or her possession or under his or her control a document which has a bearing on the subject of the appeal, to appear before it at a time and place specified in the summons, to be asked questions or to produce a document; (c) must, if it calls for oral evidence or argument- (i) determine the date, time and place for the appeal and must communicate these in writing to the appellant and the Council; and (ii) administer an oath to, or accept an affirmation from, any person called as a witness at the appeal. This gazette is also available free online at www.gpwonline.co.za

72 No. 40480 GOVERNMENT GAZETTE, 9 DECEMBER 2016 (7) A person appearing before the appeal committee may be represented by a legal practitioner. (8) The appeal committee must consider the appeal and make a decision within a period of 30 days from the date on which it first meets to hear the appeal. 8. Application for registration of a medical device or IVD (1) A person residing and doing business in the Republic may apply for the registration of a medical device or IVD. (2) An application for the registration of a medical device or IVD must include the particulars of the authorised representative in South Africa who is responsible for communication with the Council. (3) An application for the registration of a medical device or IVD must be made on the appropriate form obtainable from the Registrar and must be accompanied by - (a) the completed application form; (b) a proposed label for use on the medical device or IVD, if applicable; (c) the instructions for use of the medical device or IVD; (d) where applicable, (i) a copy of the manufacturer licence or distributor licence together with a conformity assessment certificate of a Quality Management System for the local medical device establishment, as determined by the Council; and (ii) a certified copy of the conformity assessment certificate to a quality standard, as determined by the Council, for the medical device or IVD to be registered, and which is issued by a Conformity Assessment Body; (e) any other information as the Council may determine; and (f) the application fee. (4) The information referred to in sub-regulation (3) must, at least, be in English. (5) The application form referred to in sub-regulation (3)(a) must contain at least the following information: (a) Particulars of the prospective holder of the certificate of registration: (i) Name; This gazette is also available free online at www.gpwonline.co.za

STAATSKOERANT, 9 DESEMBER 2016 No. 40480 73 (ii) Business Address; (iii) Postal Address; (iv) Telephone Number; (v) Fax Number, where available; (vi) e-mail address; and (vii) contact details of the authorised representative referred to in sub-regulation (2). (b) Particulars of the medical device or IVD: (i) The name and group or family name, make and model, where applicable; (ii) intended purpose or use; (iii) classification and registration status in recognised authorities outside the Republic, as determined by the Council, and proposed classification in the Republic; (iv) nomenclature system code; (v) in the case of a combination device, the name and quantity of the scheduled substances or biological substances; (vi) the name and physical address of the original manufacturer; and (vii) the name and physical address of the clinical investigation sites, where applicable. (6) A medical device or IVD, in respect of which an application for registration is made, must comply with the Essential Principles for Safety and Performance of Medical Devices which include requirements for quality, safety and performance, as determined by the Council. (7) An application for registration of a medical device or IVD must be accompanied by a declaration of conformity by the authorised representative as determined by the Council. (8) An application must be made in respect of each individual medical device or IVD, or medical device or IVD group or family or modification thereof, as determined by the Council. (9) In an instance where a medical device or IVD in respect of which an application is made, is registered with a regulatory body outside the Republic, the following information in respect of the medical device or IVD must accompany the application: This gazette is also available free online at www.gpwonline.co.za

74 No. 40480 GOVERNMENT GAZETTE, 9 DECEMBER 2016 (a) A certified copy of the certificate of registration or premarket approval, where applicable; (b) instructions for use, where applicable; (c) conditions of registration; and (d) any other information determined by the Council. 9. Information that must appear in register for medical devices or IVDs The medical device or IVD register must, in respect of a registered medical device or IVD, contain the following information: (a) The name and group or family and the make and model, where applicable, of the medical device or IVD; (b) the registration number allocated to the medical device or IVD; (c) in the case of a combination device, the name and quantity of the scheduled substances or biological substances in the medical device; (d) the intended purpose or use of the medical device or IVD; (e) the name of the holder of the certificate of registration; (f) the name and address of the original manufacturer; (g) the date of registration of the medical device or IVD; (h) the conditions of registration of the medical device or IVD; (i) the class of medical device or IVD; and (j) the nomenclature system code allocated to the medical device or IVD. 10. Amendment to medical device and IVD Register (1) A holder of a certificate of registration may submit to the Registrar an application on a form, as determined by the Council, to amend an entry made in the medical devices or IVDs register with regard to a particular medical device or IVD. (2) The application referred to in sub-regulation (1) must be accompanied by the prescribed fee, and must contain the following information: This gazette is also available free online at www.gpwonline.co.za

STAATSKOERANT, 9 DESEMBER 2016 No. 40480 75 (a) The registration number of the medical device or IVD; (b) the name and business address of the holder of a certificate of registration and the authorised representative; (c) a declaration by the authorised representative that the information furnished is complete and accurate; (d) the details of the amendment applied for; (e) the manufacturer licence number of the manufacturer or the distributor licence number of the distributor; and (f) any other information determined by the Council. 11. Classification of medical devices and IVDs (1) The following are the classes of medical devices and IVDs: (a) Class A - Low Risk; (b) Class B - Low-moderate Risk; (c) Class C - Moderate-high Risk; (d) Class D - High Risk, where risk relates to the patient, user or to public health. (2) Medical devices, except custom made medical devices, and IVDs must be registered with the Council in terms of call up notices before they may be sold or used in the Republic. (3) The Council must determine the classification of medical devices and IVDs in accordance with the classification rules. (4) Where the classification of a medical device or IVD is inconclusive and places it in more than one class, or between classes, the Council must, after following the classification rules, place the medical device or IVD in the higher of the risk classes. (5) The Council must consider the classification of a medical device or IVD individually, taking into account its design and intended use. This gazette is also available free online at www.gpwonline.co.za