Statistics Act, 1999
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)22. Labelling of medical device or IVD |
| (1) | The label of each medical device or IVD must contain the following particulars: |
| (a) | The name or trade name of the medical device or IVD; |
| (b) | product description and intended use; |
| (c) | a product catalogue code, where applicable; |
| (d) | the name and business address of the manufacturer; |
| (e) | the name and business address of the holder of the certificate of registration; |
| (f) | where appropriate, an indication that the medical device contains or incorporates a scheduled or biological substance; |
| (g) | the lot number, where applicable; |
| (h) | the serial number, where applicable; |
| (i) | for accessories, the serial number may be substituted with a control number and for software it may be substituted with a version number; |
| (j) | the expiry date, where applicable; |
| (k) | where there is no indication of the expiry date, the manufacturing date; |
| (I) | an indication of the special storage or handling conditions applicable; |
| (m) | if the medical device is supplied sterile, an indication of its sterile state and, where appropriate, the sterilisation method; |
| (n) | where relevant, an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of these or other terms which accurately reflect the contents of the package; |
| (o) | warnings or precautions, where applicable; and |
| (p) | where appropriate an indication that the medical device is intended for— |
| (i) | single use; |
| (ii) | clinical investigation or premarket clinical performance study; |
| (iii) | non- clinical research, teaching or testing purposes; |
| (iv) | presentation or demonstration purposes; |
| (v) | in vitro diagnostic use or Laboratory Developed Tests; and |
| (vi) | where relevant, "for professional use only or "near patient testing" or "point of care" or "self- testing ". |
| (2) | The label of each medical device or IVD must be in at least English and must appear— |
| (a) | on the medical device or IVD itself; or |
| (b) | on the packaging of each unit; and |
| (c) | on the packaging of multiple medical devices or IVDs. |
| (3) | If the medical device is a reprocessed medical device, the label must state the name of the re- processor and identify the medical device as a reprocessed medical device. |
| (4) | If an IVD kit includes individual reagents and articles that may be made available as separate IVD medical devices, they must comply with the requirements set out in subregulation (1). |
