The draft regulations were published in the Government Gazette on 22 July 2011 (under notice 586 in Government Gazette No. 34463) for public comment. The three month period for public comment expired on or about 22 September 2011.
Regulations relating to medical devices
The proposed regulations consist of two sets of regulations. The first deals with regulations relating to medical devices. This set stands independently from regulations already in place under the Medicines and Related Substances Act No. 101 of 1965, as amended (the Medicines Act).
The scope and ambit of the regulations is dependant largely on whether or not a particular item falls within one of the eight categories of medical devices that are identified in proposed regulation 2. In so far as an item does fall within one of the categories, the item must be registered within that category as a medical device with the Medicines Control Council (the MCC).
The categories that have been published for comment are as follows:
" (a) Category C1: non-invasive medical devices which do not penetrate the body;
(b) Category C2: invasive medical devices that in whole or in part, penetrate the body, either through a body orifice or through the surface of the body;
(c) Category C3: active medical devices whose operation depend on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting energy;
(d) Category C4: combination medical devices that incorporate, as an integral part, a substance which, if used separately, can be considered to be a medicine, and which act son [sic] the human body with action ancillary to that of the medical device;
(e) Category C5: medical devices that are manufactured from or incorporating animal with human cell, tissue [sic] or derivative thereof;
(f) Category C6: medical devices used for sterilising or disinfecting other medical devices;
(g) Category C7: medical devices used for contraception or the prevention of the transmission of sexually transmitted diseases; and
(h) Category C8: in vitro diagnostic medical devices which, whether used alone or in combination, are intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes".
The legal obligation to register a medical device will become operative once the final regulations are published. In terms of proposed regulation 4(1), the sale of an unregistered medical device will become prohibited.
The legal obligation to register a medical device will arise under proposed regulation 2. However, it is not clear whether or not the proposed regulations are to apply retrospectively to devices that are already in the marketplace and in use and where no sale occurs as contemplated in proposed regulation 4(1).
The proposed regulations endeavour to create a system of regulation in terms of which the MCC will determine which categories of medical devices are to be registered. Presumably, the MCC will issue a call-up notice, pursuant to proposed regulation 4(2), and require that category of medical devices to become registered.
In this regard, the resolution by the MCC will, in all likelihood, be published in the Government Gazette timeously under the direction of the Registrar of Medicines. Once such a publication occurs, an application for the registration of a medical device will have to be submitted to the MCC in accordance with the provisions and detailed contained in proposed regulation 5.
In terms of proposed regulation 6, manufacturers, importers or local representatives of such manufacturers of medical devices will have two years from the date that the regulations become effective to provide specified information to the Registrar of Medicines.
This information is set out in proposed regulations 6(1)(a) to (g) and includes the following:
" (a) name of the manufacturer or importer;
(b) address of [the] manufacturer or importer;
(c) name of [the] medical device;
(d) unique identification number, where practicable [of the medical device];
(e) [the] number [applied to medical device] according to an internationally recognised device nomenclature system as approved by the Council;
(f) category or class of medical device; and
(g) brief description of the medical device and its use".
Once the information is supplied to the Registrar, the Registrar will then allocate the medical device a number in accordance with proposed regulation 6(2). The number is not a registration, but rather recognition by the MCC of the existence of the device in the Republic.
Proposed regulation 6(4) allows the MCC to impose particular requirements on that medical device, which are currently unknown, "in order to ensure that the medical device is safe and of good quality".
The balance of the proposed regulations endeavour to align the control of medical devices with the manner of regulatory control already imposed by the Medicines Act on medicines.
Therefore, further proposed regulations deal with:
- amending and updating registration details;
- transferring certificates of registration;
- licensing manufacturers,
- exporters and importers; the duties of licence holders; and
- cancelling a registration or licence.
Particular provision is also made for combination devices in proposed regulation 7.
Advertisements and promotions will be particularly controlled in terms of proposed regulation 13. In terms of proposed regulation 13(2), the MCC may prohibit the promotion or restrict the advertisement of certain medical devices "to the general public".
Proposed regulations for labelling and instructions for use for medical devices are contained in proposed regulation 14.
The manner in which medical devices are to be disposed of is outlined in proposed regulation 18.
In terms of proposed regulation 17, the MCC is afforded power to recall medical devices and specific duties are imposed upon persons using medical devices in health establishments. In this regard, the head of any health establishment attracts certain duties to ensure that the use of medical devices complies with the regulations in terms of proposed regulations 19 and 20.
In terms of proposed regulation 22 any person who contravenes the provisions of the proposed regulations, once final, is guilty of an offence. He or she will be liable for a fine and imprisonment for a period not exceeding five years or to both the fine and imprisonment.
Regulations relating to complementary medicines
Regulations concerning the control of complementary medicines are also proposed. However, these regulations are amendments to the existing general regulations in terms of the Medicines Act.
The scope and ambit of the amendments turn directly on the definition of "complementary medicine". A complementary medicine will be defined as follows:
"a medicine that is used –
- or intended to be used for, or manufactured or sold for use in assisting innate healing power of a human being or animal; and
- in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982)" (emphasis added).
Complementary medicines fall within a category of medicines described as category D. Category D medicines are those in addition to the medicines or substances that are classified currently in categories A to C in terms of the General Regulations to the Medicines Act.
The introduction of formal regulations for complementary medicines is a significant step in the control of an extensive complementary medicines market in the Republic. Should the regulations proceed in their current format, complementary medicines - or substances falling within the four corners of the definition contained in the proposed regulations - will be subjected to the same process for registration as substances that fall into the existing categories A to C of the Medicines Act.
Therefore, complementary medicines will be treated in almost the same manner, from a regulatory and registration point of view, as is currently applicable to branded or allopathic medicines. Such a system of registration presents unique challenges for the purposes of controlling complementary medicines bearing in mind the broad nature of the types and variations of substances that fall within this category.
The one failing that is immediately noticeable is the division of complementary medicines into two distinct markets:
- the first is the market defined by the definition contained in the proposed regulations, being the market dealt with and governed by the professions regulated under the Allied Health Professions Act No. 63 of 1982, and
- the second is the market consisting of those complementary medicines that are used by professions not governed by the aforementioned Act or the Health Professions Act No. 56 of 1974, as amended.
The legality of such a definition will have to be carefully examined in relation to the principles of administrative law and the Constitution of the Republic of South Africa, 1996. This may produce the result that the definition of "complementary medicine", upon which legality of the balance of the regulations pertaining to complementary medicines rests, may be too vague for proper enforcement in terms of existing principles of South African law.
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