Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)1. Definitions |
In these Regulations a word or expression defined in the Act bears the meaning so assigned and unless the context otherwise indicates—
"adverse event"
in relation to a medical device or IVD means possible faults or failures of a medical device or IVD or difficulties in the use of or an undesirable outcome associated with the use of a medical device or IVD that can or does result in permanent impairment, injury or death to the professional user or patient user;
"as determined by the Council"
means as determined by the Medicines Control Council in the guidelines published in the Gazette from time to time;
"authorised representative" means a natural person, resident in the Republic of South Africa, who—
| (a) | has the written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider in the Republic; |
| (b) | acts on behalf of a manufacturer importer, distributor, wholesaler, retailer or service provider for specified tasks with regard to the latter's obligations and in whose name the manufacturer licence, distributor licence, wholesaler licence or certificate of registration is issued; and |
| (c) | is responsible for all aspects of the medical device or IVD, including performance, quality, safety and compliance with conditions of registration, clinical trials or clinical investigations; |
means a unique number or combination of numbers or cyphers allocated to a lot or a batch or a unique medical device or unique accessory to a medical device in the case of "control number", or unique software in the case of "version number" by the manufacturer;
"biological substance"
means a substance derived from a human, animal or a microorganism;
"bonded warehouse"
means a customs and excise warehouse licensed in terms of section 19 of the Customs and Excise Act, 1964 (Act No. 91 of 1964);
"clinical investigation or clinical trial"
means a study in respect of a medical device or IVD for use in humans and animals that involves human or animal subjects and that is intended, through assessment and analysis of the clinical data pertaining to a medical device, to discover or verify the safety or clinical performance of the medical device or IVD when used as intended by the manufacturer;
"clinical performance study of an IVD"
means a study undertaken to establish or confirm the clinical performance of an IVD;
"combination device"
means a medical device, incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicine and which is liable to act on the human body with action ancillary to that of the medical device;
"conformity assessment"
means the systematic examination of evidence generated and procedures undertaken by the manufacturer, to determine that a medical device or IVD is safe and performs as intended and that the medical device or IVD fulfils the Essential Principles of Safety and Performance for Medical Devices or IVDs, as determined by the Council;
"conformity assessment body"
means a body corporate or other legal entity, locally or internationally, accredited by SANAS or an international body recognised by the Council as competent to carry out the assessment, verification, inspection testing or certification, as applicable, of medical devices or lVDs, before they are placed on the market by manufacturers, according to criteria determined by the Council;
"conformity assessment certificate"
means a certificate issued, by a Conformity Assessment Body, to demonstrate compliance with the Essential Principles of Safety and Performance for Medical Device and IVD requirements;
"custom made medical device"
means a medical device—
| (a) | specifically made in accordance with a written prescription or order given by a person authorised for the same by virtue of professional qualifications; |
| (b) | specifically made in accordance with specific design characteristics; |
| (c) | which is intended for the sole use of a particular user; and |
| (d) | which excludes mass produced medical devices that only need adaptation to meet the specific requirements of the health professional user; |
"declaration of conformity"
means the procedures whereby the manufacturer ensures and declares that the application of the quality system approved for the design, manufacture and final inspection of the products concerned, as required by the Council, which are subject to audit and surveillance, are fulfilled;
"distributor"
means a natural or legal person who—
| (a) | imports or exports a medical device or IVD, which is on the register for medical devices or on the register for IVDs in its final form, wrapping and packaging, with a view to the medical device or IVD being placed on the market under the natural or legal person's own name; and |
| (b) | sells the medical device or IVD to a healthcare professional, healthcare institution, wholesaler or the user; |
"essential principles"
means the requirements relating to the safety and performance characteristics of medical devices and IVDs determined by the Council;
"expiry date"
means the date up to which a medical device or IVD retains the properties which are mentioned on the label, which properties can change after the lapse of time, and after which date the medical device or IVD may not be sold to the public or used;
"family"
means a medical device or IVD comprising of the same type of medical device available in different models and sizes;
"group"
means a medical device or IVD comprising a collection of medical devices or IVDs such as a procedure pack, procedure tray, system or procedure kit, that are packaged together for a specific intended purpose and sold under a single name;
"holder of a certificate of registration"
means a person in whose name a registration certificate has been granted and who is responsible for all aspects of the medical device or IVD, including performance, quality, safety and compliance with conditions of registration;
"implantable device"
means a medical device, including a medical device that is partially or wholly absorbed, which—
| (a) | is intended to be totally introduced into the human body or, to replace an epithelial surface or the surface of the eye by surgical intervention; and |
| (b) | is intended to remain in place for at least 30 days after the procedure; |
"intended purpose"
means the objective, intended use or purpose, as the case may be, for which a medical device or IVD is intended according to the data supplied by the manufacturer or authorised representative on the labelling, in the instructions for use and in the promotional materials;
"IVD "
("in-vitro diagnostic") means a medical device, whether used alone or in combination, 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;
"lay person"
means a person who does not have formal training in a relevant field or discipline;
"manufacture"
means operations that include the design, purchasing of material, specification development, production, fabrication, assembly, processing, reprocessing, releasing, packaging, repackaging, labelling, and refurbishing of a medical device or IVD, as the case may be, and includes putting a collection of medical devices or IVDs, and possibly other products, together for a medical purpose in accordance with quality assurance and related controls;
"manufacturer"
means—
| (a) | a natural or legal person with the responsibility for the design, manufacture, packaging and labelling of a medical device or IVD before it is placed on the market under the natural or legal person's own name, or in the name of a firm or company, regardless of whether these operations are carried out by that person by himself or on his or her behalf by a third party; or |
| (b) | any other person who assembles, packages, reprocesses, refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a medical device or IVD, with a view to their being placed on the market under the natural or legal person's own name, except a person who assembles or adapts medical devices or IVDs already on the market to their intended purpose for patients; |
"misbranded"
means a medical device labelling is false, misleading, inaccurate or fails to provide information as required;
"modification"
in relation to a medical device or IVD means—
| (a) | any significant change in a medical device or IVD; |
| (b) | any change in the purpose of a medical device or IVD, where significant change may include— |
| (i) | the manufacturing process; |
| (ii) | facility or equipment; |
| (iii) | the quality control measures used to control the quality and sterility of a medical device or IVD; or |
| (iv) | a change of the materials used in manufacture, the design of a medical device or IVD, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories and the intended use of a medical device or IVD; |
| (c) | any new or extended use, any addition or deletion of a contra -indication of a medical device or IVD; and |
| (d) | any change to the period used to establish its expiry date; |
means testing performed outside a laboratory environment by a healthcare professional not necessarily a laboratory professional, generally near to, or at the side of, a patient;
"nomenclature"
means the common generic description as per the Global Medical Device Nomenclature for medical devices having similar features, characteristics and intended use;
"person"
means both a natural and a legal person;
"radiation"
means energy in the form of electromagnetic waves or acoustical waves;
"refurbish"
in relation to a medical device or IVD means the whole or part of a medical device or IVD is substantially rebuilt, re- equipped, reworked or restored, whether or not using parts from one or more used medical devices of that same kind, so as to create a medical device or IVD that is used for the purpose originally intended by the original manufacturer of the original medical device or IVD, and without prejudice to the generality of the foregoing, refurbishment of a medical device may involve any or all of the following actions including, but not limited to, repair, rework, update of software or hardware and replacement of worn parts with parts approved for use by the original manufacturer, performed in a manner consistent with product specifications and service procedures defined by the original manufacturer for that type of equipment without significantly changing the finished equipment's performance, safety specifications or intended use as defined in its original registration;
"research use only IVD"
("RUO IVD") means an IVD labelled for "research use only" and "for investigational use only" and may not be used for clinical diagnostic purposes;
"reprocess"
means the activity carried out on a used medical device in order to allow its safe re-use including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoration of the technical and functional safety of the used medical device;
"self-testing"
means testing performed by a lay person;
"single use"
in terms of a medical device means one use of a medical device on an individual or IVD on a sample during a single procedure and then the medical device or IVD is disposed of and is not reprocessed and not used again;
means the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965);
"user"
means a person or organisation that uses a medical device or IVD; and
"wholesaler"
means a dealer who purchases medical devices or IVDs from a manufacturer or distributor and sells them to a retailer.