How to obtain the GDPMDS Certificate, Importer Licence and Wholesaler Licence

First you need to set up a Quality Management System that comply to the GDPMDS requirements.

You can contact one of the professional consulting companies to set one up for you and guide you in the implementation of the quality management system.

Consultants	Contacts	Services
		Registration Regulatory Affairs Quality Management System Procedures & Work Instructions, Training Annual Audit
		Medical Device Regulatory Consultancy QMS, SOP, WI

 

Once you have implemented the QMS, you can contact a certification body to perform a certification audit.

Certification Body

AJA REGISTRARS PTE LTD

BUREAU VERITAS CERTIFICATION (SINGAPORE) PTE LTD

CERTIFICATION INTERNATIONAL (SINGAPORE) PTE LTD

DAS CERTIFICATION SINGAPORE PTE LTD

LLOYD'S REGISTER QUALITY ASSURANCE LIMITED

SGS INTERNATIONAL CERTIFICATION SERVICES SINGAPORE PTE LTD

TÜV SÜD PSB PTE LTD

If you have passed the certification body audit, you will be issued a GDPMDS certificate. You can go on line at HSA website to apply for the Importer Licence and Wholesaler Licence.

 

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.