GDPMDSGood Distribution Practice for Medical Device in SingaporeHomeAboutNewsResourcesConsultantsCalendarLinksGDPMDSHomeCompanies 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.
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 Wholesale