Singapore legislation
Regulation 38
Regulation 38
Duty to maintain records of manufacture
Subregulation 1
A manufacturer of a medical device shall maintain records of —
such information relating to the medical device and its manufacture or assembly as the Authority may specify; and
the manufacture of each batch of the medical device and of the tests carried out thereon, in such manner as the Authority may specify.
Subregulation 2
The manufacturer shall maintain the records referred to in paragraph (1) for the longer of the following periods:
the projected useful life of the medical device; or
2 years after the date on which the medical device is supplied to another person.
Subregulation 3
Any person who contravenes paragraph (1) or (2) 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.
Subregulation 4
Any person who, in compliance or purported compliance with paragraph (1), furnishes the Authority or an enforcement officer with any record which he knows is false or misleading 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.