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GDPMDS Good Distribution Practice for Medical Device in Singapore |
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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.
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Consultants |
Contacts |
Services |
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· Registration · Regulatory Affairs · Quality Management System · Procedures & Work Instructions, · Training ·
Annual Audit |
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Once you have implemented the QMS, you can contact a certification body to perform a certification audit.
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Conformity
Assessment Body (also known as Certification Body) |
If you have passed the Conformity Assessment Body audit, you will be issued a SS620:2016 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.