At present the licensing, sale and distribution of medical devices is not fully regulated under South African law. Although medical devices are included in the principal Act (Medicines and Related Substances Control Act of 1965), the industry body for medical devices has adopted the marketing codes for medicines and draft legislation on devices has been on the books for some years, the licensing, registration and sale of medical devices (simply referred to as 'devices' and including IVD's for the purposes of this note) are not strictly legally regulated.
That may soon change. On 14 July 2015 the Department of Health published draft general regulations relating to medical devices and in vitro diagnostic medical devices (Government Notice No.602 dated 14 July 2015 (GG No. 38990)). The draft regulations are wide ranging, dealing with a variety of matters from imports and conduct of clinical trials to advertising of devices.
Perhaps the most important of the draft regulations will be those which seek to control the licensing of persons entitled to manufacture, import, distribute or wholesale devices and the requirements for registration of the devices.
The purpose of this note is not to repeat the draft regulations which have been published for comment, but to highlight some key features of interest to the reader.
The draft regulations provide for three different types of licences. A manufacturing licence will permit manufacture, imports or exports. A distributor licence will permit import, export and distribution. A wholesale licence will permit wholesaling.
Any holder of a licence must appoint a natural person resident in South Africa who will be responsible for compliance with the regulations and will also be responsible to control the licensed activities. A holder must also provide evidence of accreditation to a quality management system for devices as will be determined by the Medicines Control Council.
Provisions are made for keeping of registers of licencees as well as amendment and effective cancellation of a licence for non-compliance.
Licences are valid for periods of five years at a time and may be renewed.
Registration of products
Application for registration of devices can only be made by persons who reside or are 'doing business' in South Africa. Multinationals must thus appoint local representatives on a contractual basis or apply themselves through a branch or subsidiary.
An essential requirement for registration of a device is the supply of a conformity assessment certificate certifying conformity of the device to a quality standard issued by an approved assessment body. This indicates that if a device has been registered by an international body of some credibility and repute, this is likely to be accepted by the local Council. This is echoed by the requirement to lodge particulars of any existing registration by a regulatory body outside South Africa. Hopefully this will speed up the registration process.
Transfer from one party to another of the rights granted by registration is not expressly dealt with. Rather it appears that the process for transfer requires an application to 'amend' the register. The details of the applicable forms, information required and procedure are still to be determined.
Product registrations are classified from class A to D by reference to the potential risk which the device may pose to patients or public health. Classification is to be made by reference to design and intended use of the device. This rating affects things such as advertising – for instance devices registered in classes A and B may be advertised directly to lay public, whilst those in Classes C and D may not. Certain additional registration and ongoing record keeping requirements are imposed in respect of class D devices.
Clinical trials and monitoring
The draft regulations also provide for control and monitoring of the conduct of clinical trials and clinical investigations. As is the case in medicines, permission must be obtained from the Council prior to the conduct of such trials and investigations.
Holders of registration certificates of devices or the appointed representatives have further obligations imposed upon them through an adverse event reporting and control mechanism. Readers familiar with the structure and requirements for adverse events in pharmaceutical products will find these requirements very familiar.
Detailed requirements are set out regarding precisely what the instructions for use of the IVD's must contain.
Having regard to the introductory comments above regarding the slow pace of adoption of proposed laws, readers will be interested in the transitional arrangements which are proposed regarding the draft regulations. These cover unlicensed manufacturers, distributors and wholesalers and also unregistered devices.
Those persons who conduct business as manufacturers, distributors and wholesalers but are not licensed at the commencement of the regulations, will be deemed to be trading legally in an initial phase. The Council will then publish notices in the Gazette calling upon those persons to apply to be licensed within specified time periods and subject to conditions. By implication, non-compliance will only be triggered following the expiry of that time period.
Similarly in relation to product registrations, unregistered products sold at the commencement of the regulations will be deemed to be sold legally in an initial phase. The Council will issue notices from time to time, calling upon parties to register their products within specific time periods and setting out any conditions applicable to such product applications.
Comments on the regulations have been called for by 14 August 2015. The date of the commencement of the regulations will be announced by the Minister of Health, perhaps sometime soon.