Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)23. Instructions for use of medical device |
| (1) | The instructions for use must contain the following information in at least English: |
| (a) | The name or trade name of the medical device; |
| (b) | the name and business address of the manufacturer; |
| (c) | where practical, the approved intended purpose or use of the medical device and where appropriate, the intended user; |
| (d) | residual risks, contraindications and any expected and foreseeable side effects, including information to be conveyed to the patient in this regard; |
| (e) | specifications that the user requires in order to use the medical device appropriately (e.g. if the device has a measuring function, the degree of accuracy claimed for it); |
| (f) | if the medical device contains, or incorporates, a scheduled substance or a biological substance, identification of that substance, as appropriate; |
| (g) | details of any preparatory treatment or handling of the medical device before it is ready for use (e.g. sterilisation, final assembly, calibration, etc.); |
| (h) | any requirements for special facilities, or special training, or particular qualifications of the medical device user or third parties; |
| (i) | the information needed to verify whether the medical device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant— |
| (i) | details of the nature, and frequency, of preventative and regular maintenance, and of any preparatory cleaning or disinfection; |
| (ii) | identification of any consumable components and how to replace them; |
| (iii) | information on any necessary calibration to ensure that the medical device operates properly and safely during its intended life span; and |
| (iv) | methods of eliminating the risks encountered by persons involved in installing, calibrating or servicing - medical devices; |
| (j) | an indication of any special transport, storage or handling condition that applies; |
| (k) | if the medical device is supplied sterile, instructions in the event of the sterile packaging being damaged before use; |
| (I) | if the medical device is supplied non -sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation; |
| (m) | if the medical device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of re- sterilisation including information to identify when the medical device should no longer be reused (e.g. signs of material degradation or the maximum number of allowable reuses); |
| (n) | for medical devices intended for use together with other medical devices or general purpose equipment— |
| (i) | information to identify such medical devices or equipment, in order to obtain a safe combination; and |
| (ii) | information on any known restrictions to combinations of medical devices and equipment; |
| (o) | if the medical device emits hazardous, or potentially hazardous levels of radiation for medical purposes |
| (i) | detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation; and |
| (ii) | the means of protecting the patient, user, or third party from unintended radiation during use of the medical device; |
| (p) | information that allows the user and patient to be informed of warnings, precautions, measures to be taken and limitations of use regarding the medical device which information must cover, where appropriate— |
| (i) | warnings, precautions and measures to be taken in the event of malfunction of the medical device or changes in its performance that may affect safety; |
| (ii) | warnings, precautions and measures to be taken in regard to the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature; |
| (iii) | warnings, precautions and measures to be taken in regard to the risks of interference posed by the reasonably foreseeable presence of the medical device during specific diagnostic investigations, evaluations, therapeutic treatment or use (e.g. electromagnetic interference emitted by the medical device affecting other equipment); |
| (iv) | if the medical device administers a scheduled substance or a biological substance, any limitations or incompatibility in the choice of substance to be delivered; |
| (v) | warnings, precautions and limitations related to the scheduled substance or biological substance that is incorporated into the medical device as an integral part of the medical device; and |
| (vi) | precautions related to materials incorporated into the medical device that are carcinogenic, or in or reaction of the patient or user; |
| (q) | warnings and precautions to be taken related to the disposal of the medical device, its accessories and the consumables used with it, if any. This information must cover, where appropriate |
| (i) | infection or microbial hazards (e.g. explants, needles or surgical equipment contaminated with potentially infectious substances of human origin); |
| (ii) | environmental hazards (e.g. batteries or materials that emit potentially hazardous levels of radiation); and |
| (iii) | physical hazards (e.g. from sharps); |
| (r) | for medical devices intended for use by a lay- person, the circumstances when the user must consult with a healthcare professional; |
| (s) | the date of issue or latest revision of the instructions for use and, where appropriate, an identification number; and |
| (t) | appropriate service and maintenance instructions for technical equipment and medical devices, where applicable. |
| (2) | Instructions for the use of a medical device must be included with the sale of each medical device, however, instructions for the use of Class A medical devices must be included, where applicable. |