Good Distribution Practice for Medical Device in Singapore
Companies that are involved in wholesaling and/or importing Medical Devices in Singapore are required to pass the GDPMDS certification audit prior to applying for Importer or Wholesaler’s 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 GDPMDS system or can employ GMP/GDP consultant’s compliance to save you some time and minimise abortive efforts if you 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 9001:2008 will find that they have partially fulfilled the GDPMDS requirements. However there are differences between ISO 9001:2008 and GDPMDS or ISO13485:2003 which companies will need to reconcile before going for certification.
Companies are encourage to get certified early and apply for their licence before the mandatory deadline to avoid a last minute panic and potential business interruption. Companies who have not implemented a system which complies with the GDPMDS requirements will need time to implement the system, generate records through the normal business process and test out their systems prior to applying for certification. Depending on the nature of the business, this could take several months.
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.
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.