September 17, 2018

For Medical devices that will be used for exhibition purposes in Singapore, GN-32 R3.1 is the latest guidance published. In the said document, the following provision is stated in definitions (Section 1.5):

“Definitions that do not indicate they are set out in the Act or Regulations are intended as guidance in this document. These definitions are not taken verbatim from the above legislation and should not be used in any legal context. These definitions are meant to provide guidance in layman terms.”

In addition, HSA added the definition of “Medical Device” and “Supply” as follows:

MEDICAL DEVICE: means ––

(a) any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of ––

(i) Diagnosis, prevention, monitoring, treatment or alleviation of disease;

(ii) Diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;

(iii) Investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;

(iv) Supporting or sustaining life;

(v) Control of conception;

(vi) Disinfection of medical devices; or

(vii) Providing information by means of in vitro examination of specimens derived from the human body, for medical or diagnostic purposes,

and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means; and

(b) The following articles:

(i) Any implant for the modification or fixation of any body part;

(ii) Any injectable dermal filler or mucous membrane filler;

(iii) Any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means.

Meanwhile, GN-33 R1.2 is the latest document on application of Singapore Standard GDPMDS which added the following provision on Storage Conditions (Section 7.1.2):

“There should be adequate storage areas, and where applicable, physically separated zones for the orderly segregation of medical devices. There should be designated areas for quarantined, saleable stock, expired, rejected/damaged, recalled and returned medical devices. Alternative means of segregation may be considered if proven, to prevent mix-up.”

These minor revisions of GN 32 and GN 33 are now available in HSA website. Stakeholders are advised to make sure that they use the latest guidance documents to avoid confusion and delay.

Reference: 

1) GN32 R3.2 Guidance Notes for Importation of Unregistered Medical Devices for Exhibition in Singapore(18Sep-pub)

2) GN-33 R1.2 Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices (18Jul-pub)