Singapore legislation

Regulation 21

of Healthcare Services (Outpatient Medical Service) Regulations 2023

Regulation 21

Testing of specimen

Subregulation 1

Subject to paragraph (2), a licensee must not test any specimen for a patient unless —

(a)

a medical practitioner or collaborative prescribing practitioner who is the licensee’s personnel orders the test for the patient;

(b)

the testing of the specimen only involves the conduct of a simple in vitro diagnostic test; and

(c)

the testing of the specimen is provided only as a service incidental to the provision of an outpatient medical service.

Subregulation 2

A licensee who is approved to provide an outpatient medical service by remote provision must not, in the course of providing the service by that service delivery mode, direct a patient to conduct a self‑administered test on himself or herself if the testing material for the self‑administered test is a “professional use only” medical device within the meaning given by regulation 2 of the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010).