Singapore legislation
Regulation 24
Regulation 24
Assignment of medical devices into classes
Subregulation 1
For the purposes of section 29(2)(a) of the Act, the classes of medical devices shall be as specified in Part I of the Third Schedule.
Subregulation 2
For the purposes of assigning a medical device into a class of medical devices under section 29(2)(b) of the Act, the following principles shall apply:
the Authority shall have regard to the intended purpose of the medical device;
if the medical device may be assigned into 2 or more classes of medical devices, the Authority shall assign the medical device into such of those classes as represents the highest health risk posed to an end-user of the medical device;
if the medical device is designed to be used in combination with another medical device, each of the medical devices shall be classified separately;
if the medical device has 2 or more intended purposes, the medical device shall, subject to sub-paragraph (b), be assigned into a class of medical devices having regard to the most critical intended purpose of the medical device.
Subregulation 3
For the purpose of determining the health risk posed to an end‑user of a medical device under paragraph (2)(b), the Authority is to have regard to —
the general criteria for risk classification of medical devices in Part II of the Third Schedule; and
the risk classification rules for medical devices set out on the Authority’s website.