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No. S 370

Health Products Act

(CHAPTER 122D)

Health Products
(Medical Devices) (Amendment No. 3)
Regulations 2012

In exercise of the powers conferred by section 71(1) of the Health Products Act, the Health Sciences Authority, with the approval of the Minister for Health, hereby makes the following Regulations:

Citation and commencement

1. These Regulations may be cited as the Health Products (Medical Devices) (Amendment No. 3) Regulations 2012 and shall come into operation on 2nd August 2012.

Amendment of Fourth Schedule

2. Items 9 and 10 of the Fourth Schedule to the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010) are deleted and the following items substituted therefor:

“

9.	Fee for application for an importer’s licence or a wholesaler’s licence relating to an unregistered medical device —

(a)	by a private hospital, medical clinic or clinical laboratory licensed under the Private Hospitals and Medical Clinics Act (Cap. 248), or a person acting on its behalf, where the unregistered medical device is to be used by a patient of the private hospital, medical clinic or clinical laboratory

$350

(b)	by a qualified practitioner, or a person acting on his behalf, where the unregistered medical device is to be used by a patient of the practitioner

$150

(c)	where the unregistered medical device is to be used for a non-clinical purpose

$250

10.	Fee for application for an importer’s licence or a wholesaler’s licence relating to an unregistered medical device solely for export or re‑export (being a medical device manufactured solely for export or imported solely for re-export)

$250

”.

[G.N. Nos. S 542/2011; S 140/2012; S 169/2012]

Made this 1st day of August 2012.

JOHN WONG

Chairman,
Health Sciences Authority,
Singapore

[HSA (HPRG) 401:04/01-000; AG/LLRD/SL/122D/2010/9 Vol. 2]