Medical Devices. SOUTH AFRICA Bowman Gilfillan

Transcription

1 Medical Devices SOUTH AFRICA Bowman Gilfillan CONTACT INFORMATION Llewellyn Parker Bowman Gilfillan PO Box , Sandton, 2146 South Africa Definition of medical devices What is the definition of a medical device in your jurisdiction? The definition of a medical device in South Africa, as stated in the Medicines and Related Substances Control Act 101 of 165 (the Act), is given herebelow: medical device means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent - (a) used or purporting to be suitable for use or manufactured or sold for use in: (i) (ii) (iii) the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or restoring, correcting or modifying any somatic or psychic or organic function; or the diagnosis or prevention of pregnancy, and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or (b) declared by the Minister by notice in the Gazette to be a medical device, and includes any part or an accessory of a medical device.

2 2. Combination products i. Which legal regime (on medicinal product or on medical devices) applies to combination products incorporating both medicinal products (drugs/biologics) and medical devices? Medical device regulation is in its infancy in South Africa and hence given that the regulatory framework to regulate medical devices is not as extensive as that for medicines the Medical Control Counsel has taken the conservative approach and regulates combination products under the regime for medicines. As such, the medicine contained in such medical device will have to go through regulatory approval and the medical device will be controlled under the licensing provisions discussed hereunder. ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction? Regulatory approval for medical devices is in its infancy and at this stage only a license is required and regulatory approval similar to that required for medicines is not required other than where the device is an electromagnetic device (or a radiation emitting device), in which case the device must be registered with the Department of Health and bear the CE (European Conformity) mark. Please note that the Medicines and Related Substances Amendment Act 72 of 2008 will change the position with respect to medical device law significantly once it has been promulgated. However, the current position is the position set out herein as there is no indication, at present, as to when this Amendment Act will be promulgated. Medicines are regulated separately from medical devices in a much more stringent manner under the auspices of the Act (this is explained in further detail herebelow). iii. If the answer to (i) is negative, what is the scope of application of the legal regimes: evaluating both the drug and device components of the combination product? The evaluation of the medical device is limited to a licensing enquiry unless the device is an electromagnetic device (or a radiation emitting device), as explained above. The evaluation of the medicine involves regulatory approval and clinical trials conducted by the medicines control counsel so that that medicine can be registered, as no medicine which is required to be registered shall be sold without having been registered first. A contravention of this requirement will amount to an offence. iv. What are the general conditions for review, approval and marketing the combination product? Regulatory approval with respect to both the medicine and the medical device is dealt with in question 2(iii) above. With respect to marketing: Direct-to-consumer advertising of medicines (schedules 0 and 1) and medical devices is allowed provided that such advertising is done in accordance with the general guidelines which apply to advertising as given by the Advertising Standards Authority of South

3 Africa and in accordance with the specific requirements related to the advertising of health products which is set out in Appendix A of the advertising code. 3. Borderline products Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device? The only guidance given in terms of whether or not the product is considered to be a medical device is that of the definition of a medical device given above. If the device falls within this definition it is considered to be a medical device for the purposes of the Act. As stated above, medical devices are dealt with under the licensing provisions of this Act and there is no requirement for registration unless the device is an electromagnetic device (or a radiation emitting device). i. Are there any legal and binding criteria for determination whether the product is a medical device or medicinal product? The only distinction given between a medical device and a medicine is that given in the definition section of the Act. In the definition section a medical device is defined as given above in relation to question 1 and a medicine is defined as: medicine means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in - (a) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or (b) restoring, correcting or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine. Therefore, the only guidance and criteria given for the distinction between a medicine and a medical device is that given in the relevant definitions, a product falling within one of these definitions would be considered to be either a medicine or a medical device, as applicable. ii. If the answer to (i) is positive, what are the main principles for differentiation? Please see the explanation given in question 3 (i) above. iii. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? As stated above, medical device regulation is in its infancy and hence at this stage there is no case law dealing with the difference between a medicine and a medical device. iv. How is software that may have some related-medical applications regulated in your jurisdiction? Software is regulated under the Copyright Act 98 of This Act merely protects the intellectual property associated with the software rather than the application of such

4 software in the medical field. At this stage there is no separate legislation to deal with the application of software in the medical field. 4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device? Medical devices are regulated by the Medicines and Related Substances Control Act 101 of 1965 and tissues are controlled by the Human Tissue Act 65 of There are no binding criteria other than the definitions set out in these respective acts as to what constitutes a medical device and a human based tissue. The definition of a medical device is given above and the definition of tissue as set out in the Human Tissue Act (which is applicable to human tissues only) is: tissue means - (a) (b) any human tissue, including any flesh, bone, organ, gland or body fluid, but excluding any blood or gamete; and any device or object implanted before the death of any person by a medical practitioner or dentist into the body of such person. Animal tissues are not specifically legislated for. However, by inference an animal tissue would be any tissue that is not a human tissue as defined here above. i. How are products composed of cells or animal/human tissue regulated in your jurisdiction? Products composed of human tissue or cells (in the form of gametes) are controlled under the Human Tissue Act 65 of 1983 which controls the use of tissue products in transplants and the use of gametes. It is envisaged in this act that these products may be used therapeutically, prophylactically and diagnostically as set out and in accordance with the requirements set out in this Act. Hence, tissues are regulated in a manner totally different to the manner in which medicines and medical devices are regulated. ii. Are there any legal and binding criteria for determination whether the product is a medical device or cellular/tissue based product? Please see the explanation given in questions 4 and 4(i) above. iii. If the answer to (ii) is positive, what are the main principles for differentiation? Please see the explanation given above. iv. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? As stated in question 3(iii) there is no case law dealing with medical devices. Furthermore, there is no case law dealing with the definition of tissue as dealt with in the

5 Human Tissue Act. 5. Admission to trade of medical devices What are the requirements for admission (import) of medical devices into trade? In order to import medical devices a licence must be applied for. The medicines control council issues licences to manufacture, import or export, act as a wholesaler of or distribute medical devices to manufacturers, wholesalers or distributors of a medical device. The licence is issued subject to the payment of the prescribed fee and is issued upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the medical control council may determine. i. Is clinical assessment required for admitting (importing) medical devices into trade? Clinical assessment is not required per se unless the device is an electromagnetic device (or a radiation emitting device), in which case the device must be registered with the Department of Health and bear the CE (European Conformity) mark. However, when granting a licence the Medicines Control Council will look at the issues of acceptable quality assurance principles and good manufacturing and distribution practices. ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for clinical assessment? Please see above, where approval is required the device must be marked with the CE mark and hence that approval will apply and the device must be registered with the Department of Health. iii. Is certification by an external certifying body required for compliance assessment of medical devices, or is a manufacturer s declaration of conformity sufficient? As above, certification by an external body is only required when the device is an electromagnetic device (or a radiation emitting device), otherwise there are no regulatory requirements in South Africa. iv. Is administrative pre-clearance or pre-approval of medical devices required for admission of medical devices into trade, or is post-launch notification sufficient? A pre-clearance type of approval applied in so far as the licensing system is concerned as without the required licence no manufacturer, wholesaler or distributer shall manufacture, import or export, act as a wholesaler of or distribute such medical device. 6. Processing of personal data (privacy) What are the rules of processing of personal data in a number of activities performed by manufacturer/s distributors/ healthcare units with the use of medical devices. There is legislation which is due to be promulgated that deals with privacy specifically. However, at this stage the Constitution and the common law is the only applicable law. The Constitution provides that that everyone has the right to privacy, which includes the right not to have, among other things, the privacy of their communications infringed.

6 i. Are there any specific rules protecting the privacy of personal data of consumers purchasing medical devices, by manufacturer/distributors? Please refer to the comments above. ii. Are there any specific rules of processing of personal data sourced by means of medical devices containing software, by healthcare units? Please refer to the comments above. iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers? As stated above, medical device regulation is in its infancy in South Africa and as such there is no regulation dealing with such reports or any record of such incidents. iv. What is the standard for reporting adverse events, and is reporting of events in foreign countries required, and using what standards? Please refer to iii above. 7. Reimbursement What is the optimal model of reimbursement of medical devices? There is no separate reimbursement scheme for medical devices and each private healthcare insurer has its own method of reimbursement. Medical insurance is generally privately regulated in South Africa or funded as out-of pocket expenditure. However, a national health insurance scheme is currently being proposed by government. Medical devices are generally reimbursed as an integrated part of a medical procedure or service provided by the manufacturer. i. What are the rules of granting reimbursement of medical devices in your jurisdiction? Private health insurance is regulated by government and the terms and conditions thereof must comply but each scheme is free to choose a method within this framework. In so far a public healthcare is concerned the Constitution grants everyone the right to healthcare. However, recent case law suggests that this right is limited with regards to the resources available to the government and as such this right is not unfettered. 8. Distribution Is distribution and promotion of medical devices subject to legal regulation? Yes. The Medicines Control Council (MCC) regulates medicines for human and animal use, on behalf of the Department of Health. This is in accordance with the provisions of the Medicines and Related Substances Act, 1965 and the relevant Regulations made thereunder. Amongst other things, it is unlawful for medicines or medical devices to be marketed, manufactured, distributed and sold or supplied in the Republic except with the proper authorisation, registration certificates, licences, clinical trial approvals or exemptions obtained from the Medicines Control Council. The licensing system includes the Council,

7 the Registrar of Medicines and the Directorate: Inspectorate and Law Enforcement, whose duties include the issue of licences to those engaged in the sale or supply of medicines and medical devices by way of wholesale dealing. The Good Manufacturing Practice (GMP) Inspectorate and the Council are typically charged with ensuring that licence holders comply with the provisions of their licences. The wholesale or distribution of veterinary medicine or medical devices for animal use, registered with the MCC in terms of the provisions of the Medicines and Related Substance Act is subject to the same legislation and the requirements are similar. Guidance as to the manufacturing, advertisement and use of medical devices is provided by the voluntary organization for stake holders South African Medical Industry Association (SAMED). i. Are there any specific regulations determining mode of business activity of medical devices distributors? There are no specific provisions given in the Act or the Regulations which deal with this other than those given in Regulation 19 which is dealt with further herebelow. ii. Is administrative permit for medical devices distribution required? Yes. Amongst other things, it is unlawful for medicines or medical devices to be marketed, manufactured, distributed and sold or supplied in the Republic except in accordance with the proper authorisation, registration certificates, licences, clinical trial approvals or exemptions obtained from the Medicines Control Council. If imported into South Africa from a foreign manufacturer a license is awarded to an importer acting as the agent of the manufacturer, the importer being a natural or juristic person. If a natural person, the importer must be a permanent resident of South Africa. The importer may be foreign juristic person, but the foreign juristic person must be permanently represented in South Africa. A written mandate from the manufacturer appointing the importer as agent must accompany the application for the license. If the agency is transferred the new agent must apply for a new license - there is no transfer of licenses. iii. Are there any specific limitations in distributing medical devices in your jurisdiction? A license in terms of the Act is required to distribute (including importation) or manufacture medical devices. iv. Are obligations of distributors of medical devices specifically legally regulated? The obligations are specifically regulated in terms of the license granted under Regulation 19 to the Act, which regulation is given herebelow: 19. Licence to manufacture, act as a wholesaler or distribute medicines (1) A person referred to in section 22C(1)(b) of the Act: (a) must prior to commencing business as such:

8 (i) (ii) (iii) apply to the Council for a licence to manufacture, import or export, act as wholesaler or distribute medicines, Scheduled substances or medical devices; appoint, and designate as such a pharmacist who will control the manufacturing or distribution of medicines, Scheduled substances or medical devices; appoint and designate a natural person who resides in the Republic, who shall be responsible to Council for compliance with the Act; (b) must submit to the registrar an application, on a form approved and provided by the Council, for a licence as contemplated in sub-regulation (1) (a) (i); (c) must as part of the application in sub-regulation (1)(b) provide acceptable documentary proof of: (i) (ii) (iii) (iv) the particulars of the owner of the business; registration of the responsible pharmacist; qualifications of staff to manufacture, store, distribute and sell medicines, Scheduled substances or medical devices in terms of the Act; the ability to comply with good manufacturing or distribution practices as determined by Council, which must include: (aa) a copy of a local area plan of the location of the business premises indicating all adjacent properties and the nature of the business being carried on, on such properties; (bb) a floor plan of the building in which the business premises are situated; (cc) a plan of the actual layout of the business premises; (dd) an inventory of equipment to be used in conducting the business; (ee) a manual of procedures and practices to be implemented to ensure the safety, efficacy and quality of medicines, or Scheduled substances or medical devices to be manufactured or distributed and sold; (d) must specify the medicines, Scheduled substance or medical devices to be manufactured or distributed and sold; (e) must pay the application and inspection fees as determined by the Council.

9 (2) The registrar may give the person referred to in sub-regulation (1) written notice to furnish the Council with such additional documentation or information as the Council may require, within a reasonable time, speed in the notice. (3) The Council must inspect the business premises specified in the application. (4) If the Council is satisfied that: (a) (b) (c) the person referred to in subregulation (1)complies with the prescribed requirements; the application for a licence to manufacture, act as wholesaler, or distribute medicines, Scheduled substances, or medical devices complies with the prescribed requirements; the applicant is able to comply with good manufacturing or distribution practices, then the Council must approve, with or without conditions, the application and issue such person with a licence. (5) The registrar must: (a) (b) keep a separate register for each of the categories of licensees referred to in subregulation (1) (a) (i) ; and enter the licence number, the name of the licensee and his or her physical and postal addresses, in such register. (6) Notwithstanding the period of validity of the licence the licensee shall pay the annual fee for continued registration as determined by the Council. (7) A licensee must notify the registrar in writing of any change to any of the particulars furnished in the application or entered in the register, which occurs after the issue of the licence. (8) Any 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 whose entry a removal as contemplated in sub- regulation (8) has been made, must be notified of such removal and any certificate issued in respect of the registration in question shall be deemed to be cancelled as from the date on which notice has so been given. (10) The Council may direct the registrar to remove from the register the name of the licensee (a) who does not comply with the Act or the conditions of a licence;

10 (b) if the responsible pharmacist fails to control the manufacturing or distribution of medicines, Scheduled substances, or medical devices; and the licensee has failed to furnish written reasons within 21 days after the date upon which a notice is given of the Council s intention to remove the name of the licensee from the relevant register and to close such business why the licensee s name should not be removed or the business should not be closed: Provided that if the Council is of the opinion that it is in the interest of the public, it may dispense with the required notice. v. What specific rules exist for advertising and promoting medical devices? Advertising in South Africa is regulated by the Advertising Standards Authority (ASA) of South Africa. The Medicines and Related Substances Control Act 101 of 1965 (as well as general regulations promulgated in terms hereof) is also of importance as well as provisions of the Consumer Protection Bill,. Section 18C of the Medicines and Related Substances Control Act 101 of 1965 empowers the Minister, after consultation with the pharmaceutical industry and other stake holders, to make regulations relating to the marketing of medicines, including an enforceable code. PIASA (Pharmaceutical Industry Association of South Africa) has established a Code of Practice for the Marketing of Medicines in South Africa binding on its members. A number of companies in the pharmaceutical industry have agreed to subscribe to a code of practice for the marketing of medicines in South Africa based on the principle of self regulation as set out in this code. Furthermore, an amendment to the Medicines Act ( the Medicines Amendment Act ) has just been promulgated but has not yet come into effect. The proposed changes that the Medicines Amendment Act will introduce are incorporated in this chapter, where relevant. Other legislation includes: Pharmacy Act 53 of 1974; Good Pharmacy Practice in South Africa; The Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972; Labeling and Advertising Regulation promulgated in terms of the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972; Medical Schemes Act 131 of 1998; Copyright Act 98 of The Minister of Health is empowered to develop a Code of Practice ( the Code ) following industry consultation. Such a Code of Practice has been drafted and under the current drafted code, a practitioner shall not participate in the manufacture for commercial purposes or in the sale, advertising or promotion of any medicine or medical device or in any other activity that amounts to selling medicine or medical devices to the public or keeping an open shop or pharmacy. However, in certain instances individual advertisements addressed directly to medical or dental practitioners, pharmacists, registered medical auxiliaries or nurses may, at the discretion of the Advertising Standards Authority (ASA), be excluded from the application of such restrictions within this section of the Code as are from time to time considered inappropriate, bearing in mind the source of the advertisement or the professional qualifications of those to whom it is addressed; provided always that such advertisements conform in every respect to the provisions of Section I (the introductory section) and II (the general requirements section) of this Code and in the latter case are either sent directly or are published in their respective professional journals.

11 9. Manufacturing How are manufacturing practices regulated? There is a general standard that requires the application of good manufacturing practices, which is referred to specifically in the section of the Act and the regulations thereto which deals with the licensing of medical devices. i. Are there any specific standards or regulations determining the quality of manufacturing practices? The standard that applies is that of good manufacturing practices, as determined by the Medicines Control Council. When applying for a license to manufacture medical devices the manufacturer is obliged to: 1. appoint, and designate as such a pharmacist who will control the manufacturing or distribution of medical devices; 2. appoint and designate a natural person who resides in the Republic, who shall be responsible to Council for compliance with the Act; 3. submit an application form containing documentary proof of its ability to comply with good manufacturing or distribution practices as determined by Council, which must include: a. a copy of a local area plan of the location of the business premises indicating all adjacent properties and the nature of the business being carried on, on such properties; b. a floor plan of the building in which the business premises are situated; c. a plan of the actual layout of the business premises; d. an inventory of equipment to be used in conducting the business; e. a manual of procedures and practices to be implemented to ensure the safety, efficacy and quality of medical devices to be manufactured or distributed and sold. ii. If the answer to (i) is positive, how are these good manufacturing practices or quality system regulations reviewed and enforced? Frequent inspections, which may be announced or unannounced, are performed at the manufacturer of such medical devices by inspectors appointed by the Director-General of Health in order to ensure compliance with quality control and Good Manufacturing Principles (GMP). All GMP inspections are carried out in accordance with the approved procedure to ensure compliance with the South African Guide to GMP, PIC/S guidelines on GMP and WHO Guide to GMP.

12 iii. Are establishments manufacturing medical devices, or components of medical devices, required to be registered with a government regulator? As above, only a license is required and regulatory approval similar to that required for medicines is not required other than where the device is an electromagnetic device (or a radiation emitting device), in which case the device must be registered with the Department of Health and bear the CE (European Conformity) mark. The license applies to manufacturers and distributors and hence in this manner manufactures are regulated. As above, only electromagnetic devices and components thereof need to be registered in a similar manner to the registration of medicines. iv. Are these establishments inspected regularly by government regulators or authorized bodies, and what is the mode of such inspections? The Act empowers Inspectors to inspect the premises and the goods of a manufacturer or distributor at any reasonable time and to seize records and samples without a warrant if such inspector believes that a warrant would be issued to them on reasonable terms (this is associated with a suspected offence and contravention of the terms of the license including the contravention of good manufacturing practices and where the delay caused in obtaining the warrant would defeat the purposes of the entry, search and seizure. 10. Regulatory Guidance How are the requirements communicated to medical device manufacturers? There is no formal manner of communicating the requirements to medical device manufacturers as the requirements are contained in the Medicines and Related Substances Control Act 101 of 165 and the regulations thereto and manufacturers are required to take cognizance of these requirements. Where there are amendments made to the abovementioned Act such amendments or proposed amendments will be published in the Government Gazette and manufacturers will have to access that information from the Government Gazette. However, medical device manufacturers may (but are not obliged to) join the South African Medical Device Industry Association (SAMED) which is a body that facilitates the dissemination of information regarding medical devices its members. i. In what form do the laws and regulations appear that are applicable to medical device manufacturers? The laws that are applicable are primarily legislative in nature, in other words, Acts and regulations thereto apply. However, it is accepted that where there is a lacuna in the legislation the common law position will prevail in which case reference will be had to the law of contract where a contract is involved or the law of delict where there is negligence and where there is no contractual nexus. ii. Are informal guidance or the opinions of regulators available to device makers, and in what form? When the legislation is going to change these opinions and proposed changes will be published for public commentary. Otherwise guidance can be obtained from SAMED,

13 bearing in mind that SAMED is not an official regulatory body but rather an organization comprising voluntary members that are stake holders in this industry.