Regulations, Guidelines and Circulars

01 Dec 2022

10 Aug 2022


Under the Private Hospitals and Medical Clinics (PHMC) Regulation 55¹ and Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulation 41(1)² , licensee may outsource the conduct of test to overseas clinical laboratories accredited by an accreditation body approved by the Director of Medical Services (“DMS”).

The list of accreditation bodies approved by the DMS is as follows:
(a) Accreditation Canada (Canada)
(b) American Society for Histocompatibility and Immunogenetics (USA)
(c) ANSI National Accreditation Board (ANAB) (USA)
(d) Association for the Advancement of Blood & Biotherapies (AABB) (USA)
(e) College of American Pathologists (USA)
(f) Danish Accreditation (DANAK) (Denmark)
(g) Deutsche Akkreditierungsstelle (DAkkS) (Germany)
(h) Dutch Accreditation Council (Raad voor Accreditatie) (The Netherlands)
(i) Foundation for the Accreditation of Cellular Therapy (USA)
(j) International Accreditation New Zealand (New Zealand)
(k) National Association of Medical Examiners (USA)
(l) National Association of Testing Authorities (Australia)
(m) National Pathology Accreditation Advisory Council (Australia)
(n) Singapore Accreditation Council-Singapore Laboratory Accreditation Scheme (Singapore)
(o) Swiss Accreditation Services (Switzerland)
(p) Taiwan Accreditation Foundation (Taiwan)
(q) The Joint Commission (USA) (formerly known as Joint Commission on Accreditation of Healthcare Organizations)
(r) United Kingdom Accreditation Service (formerly known as Clinical Pathology Accreditation) (UK)

¹Private Hospitals and Medical Clinics (PHMC) Regulations:

Outsourcing of conduct of test and examination of samples Regulation 55.

(1) Subject to paragraph (2), all tests and examinations to be performed by a clinical laboratory shall be performed at the licensed premises of such clinical laboratory.
(2) The licensee of a clinical laboratory shall not outsource the conduct of any test or examination or any part thereof except to —
(a) another licensed clinical laboratory; or
(b) any foreign clinical laboratory which has been accredited by an accreditation body approved by the Director. 

²Healthcare Services Clinical Laboratory Service and Radiological Service (CLSRS) Regulations:

Outsourcing of tests or radiological examinations
41.— (1) A clinical laboratory service licensee may only appoint or engage any of the following persons to conduct a test on the licensee’s behalf:

(a) any other person who holds a clinical laboratory service licence under the Act;
(b) a person who operates a clinical laboratory outside Singapore that is accredited by an accreditation body approved by the Director;
(c) where none of the persons mentioned in sub-paragraph (a) or (b) is willing or able to conduct the test, a person who operates a clinical laboratory that is approved by the Director.

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