| (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. |
