40. Qualified practitioners to maintain records of implantable medical devices

A qualified practitioner who has introduced into the body of a person an implantable medical device listed in the Fifth Schedule shall maintain proper records of the following matters:

the name, address and national registration identity card number (if any) of that person;

the date on which the implantable medical device was introduced into the body of that person;

the name and description of the implantable medical device; (d)the lot or batch number of the implantable medical device;

the name of the manufacturer, product owner or supplier of the implantable medical device;

the model number or catalogue number of the implantable medical device.

Any person who contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

Any person who in compliance or purported compliance with paragraph (1) —

wilfully makes, or causes to be made, a false entry in any record required to be maintained under that paragraph; or

wilfully omits to make an entry required to be made by him in any such record,shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

A qualified practitioner who has introduced into the body of a person an implantable medical device listed in the Fifth Schedule shall maintain proper records of the following matters:

the name, address and national registration identity card number (if any) of that person;

the date on which the implantable medical device was introduced into the body of that person;

the name and description of the implantable medical device; (d)the lot or batch number of the implantable medical device;

the name of the manufacturer, product owner or supplier of the implantable medical device;

the model number or catalogue number of the implantable medical device.

Any person who contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

Any person who in compliance or purported compliance with paragraph (1) —

wilfully makes, or causes to be made, a false entry in any record required to be maintained under that paragraph; or

wilfully omits to make an entry required to be made by him in any such record,shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.