ABOUT 

GDPMDS.COM

GDPMDS.COM is a community site for people who import, wholesale and distribute medical devices in Singapore. It is created for the benefit of the Singapore medical devices community and the convenience of the companies who will be impacted by the new Medical Device Regulations. Objective of the site is to share information on the subject of good distribution practice of medical device -  GDPMDS. 

Information provided on this site is solely reflecting opinions or views of the individuals who contribute to the site and does not imply or intend to be authoritative on the subject. This site is not related to any government agencies, is solely a private self-help community initiatives. This site is not a commercial site and does not involve in any form of trading, profit or revenue generation. Please do not offer monetary incentives to our community members for any favors.

If you require regulatory advice please contact the respective agency. If you need professional compliance advice please contact some of the consultants or try asking the community in the forums. 

 

Medical 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.