| (1) |
A person who fails to comply with, contravenes the provisions of, or wilfully furnishes incorrect information in respect of— |
| (a) |
regulations 3 or 4 with regard to the importation or transmission of medical devices or IVDs; |
| (b) |
regulation 5 with regard to the licence to manufacture, act as a distributor or act as a wholesaler of medical devices or IVDs; |
| (c) |
regulation 14 with regard to the destruction of medical devices or IVDs; |
| (d) |
regulation 16 with regard to the conduct of clinical trials; |
| (e) |
regulation 21 with regard to the advertising of medical devices or IVDs; |
| (f) |
regulation 22 with regard to the labelling of medical devices or IVDs; |
| (g) |
regulation 23 with regard to the instructions for the use of a medical device; |
| (h) |
regulation 24 with regard to the instructions for use of an IVD; |
| (i) |
regulation 20 with regard to the compliance to the Essential Principles confirmed in the declaration of conformity; or |
| (j) |
regulation 17 with regard to reporting of adverse events and vigilance, |
is guilty of an offence and upon conviction is liable to a fine, or to imprisonment for a period not exceeding 10 years.
| (2) |
A person who sells a medical device or IVD that has expired is guilty of an offence and upon conviction is liable to a fine, or to imprisonment for a period not exceeding 10 years. |
Estate Agency Affairs Act, 1976
