F.A.Q. 

Frequently Asked Questions

 

To find out whether the product you are handling is considered as a medical device, you can test it with the following definition of medical device:

 

`Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,

• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

• investigation, replacement, modification, or support of the anatomy or of a physiological process,

• supporting or sustaining life,

• control of conception,

• disinfection of medical devices,

• providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;

and

b) 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.

Source: The Global Harmonization Task Force — Information Document Concerning the Definition of the Term “Medical Device” Doc: GHTF/SG1/N29R16:2005 and also defined in the Republic Of Singapore Government Gazette Acts Supplement - Health Products Act 2007 (No. 15 of 2007)

Acronyms

GDPMDS	Good Distribution Practice for Medical Devices in Singapore.
ISO 13485	ISO Standard - for Medical devices -- Quality management systems -- Requirements for regulatory purposes
QMS	Can be defined as a set of policies, processes and procedures required for planning and execution (production / development / service) in the core business area of an organization. QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance.

iMedical Device Regulatory Timelines
The Health Products Act 2007 came into operation on 1st Nov 2007.
30 April 2010 — Last day for submitting Class C and Class D Medical Device for inclusion onto H.S.A.’s Transition List. (Note: Submitted dossier will be subjected to screening and evaluation).
From 10 August 2010 — Companies without Importer Licence will not be allowed to import medical devices. Companies without Wholesaler Licence will not be allowed to supply medical devices. (Note: To be eligible to apply for Importer or Wholesaler Licence, a company must have a valid GDPMDS certificate.)
From 10 August 2010 — Companies that manufactures finished medical devices is required to obtain a manufacturer's licence from HSA. (Note: To be eligible to apply for Manufacturer's License, a company must have a valid ISO 13485 certificate.)
From 10 August 2010 — Companies are prohibited from supplying unregistered Class C or Class D medical devices unless their product is listed on the SMDR or is on the Transition List.
31 August 2011 — Last day for submitting Class A and Class B Medical Device for inclusion onto H.S.A.’s Transition List. (Note: Submitted dossier will be subjected to screening and evaluation).
From 01 January 2012 — Companies are prohibited from supplying unregistered medical devices of all classes unless they are authorised by H.S.A or listed on the Transition List.
* The above information is subject to change, please check with H.S.A. for the latest updates.