Singapore legislation
Regulation 13B
Regulation 13B
Supply of “trained user only” medical devices
Subregulation 1
For the purposes of section 17(1) of the Act, a person must not supply a “trained user only” medical device to another person (P) unless the person, at or before the time the medical device is supplied to P —
provides, or ensures the provision of, such training on the safe and efficacious use of the medical device as the manufacturer of the medical device determines is necessary, to every user of the medical device; or
ensures that every user of the medical device has received the training mentioned in sub‑paragraph (a).
Subregulation 2
In paragraph (1) —
Definition
““trained user only” medical device” means —
a registered “trained user only” medical device; or
an unregistered “trained user only” medical device supplied in accordance with regulation 8 or 10;
Definition
“user”, in relation to a medical device, means an individual who is an employee or contractor of, or otherwise associated with, P.