GDPMDS

Good Distribution Practice for Medical Device in Singapore

 

SS620 GDPMDS Home

Companies that are involved in Importing and/or Wholesaling of Medical Devices in Singapore are required to pass the SS620 GDPMDS certification audit, obtaining the certificate prior to applying for Importer or Wholesaler Licence . In order to be certified by the certification bodies, companies are required to have implemented a quality management system that adheres to current good distribution practices.

Medical devices companies are required to implement quality management system, procedures and facilities to handle the medical devices in accordance to current Good Manufacturing or Distribution Practice of Medical Devices.

Companies can use the resources on this website as well as the links to develop their QMS system or  can employ consultant to assist in developing the QMS for them to minimise abortive efforts if they have not done similar system before.

Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation or product specification. In order to provide such assurance, companies will require more than just a set of quality manuals, it requires a comprehensive systems to “give assurance”. This may include appropriate procedures, suitably qualified personnel, correct processes / facilities / equipment as well as clear and timely documentation, to credibly demonstrate the consistency of quality assurance.

Companies who are currently certified to ISO 9001 will find that they have partially fulfilled the SS620 GDPMDS requirements. However there are differences between ISO 9001 and SS620 GDPMDS or ISO13485 which companies will need to reconcile before going for certification.

Companies are encourage to get certified early and apply for their licence before importing the medical device into Singapore to avoid having products being stuck at customs. To meet SS620 GDPMDS requirements will need time. It is recommended that if companies has no prior QMS experience to obtain assistance from consultants rather than attempting to do-it-yourself or purchase template which could be difficult to implement as it may not suit your business model, ending up in delaying your product launch and losing opportunities or the first in the market advantage. 

Having a well designed quality management system will give you consistent product or service quality, efficiency and cost benefits as oppose to a poorly designed one which will become a burden to your business.

 

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.
From 09 November 2020 — Singapore Standard SS620:2016 will be the standard use for certification and it will replace H.S.A. Technical Specification TS-01. There are some minor changes between SS620:2016 and TS-01.
Present — Certified to SS620:2016 or certified to ISO 13485:2016 with certificate scope covering Import, Distribution, Storage (if applicable) of the medical device types you intend to import and wholesale.
* The above information is subject to change, please check with H.S.A. for the latest updates.