GDPMDS

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Companies that are involved in manufacturing Medical Devices in Singapore are required to be certified to ISO13485 standard prior to applying for a Manufacturer’s licence from the Health Sciences Authority. Similarly, companies that are involved in distribution or importing Medical Devices in Singapore are required to obtain the GDPMDS certificate prior to applying for Importer or Wholesaler’s Licence . In order to be certified by the certification body, 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 with suitable facility and transportation to handle, store and transport 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.

Disclaimer: The information on this site may contain error, please check with the respective organisation to confirm any information which is important to you. Using this site you have agreed to the terms and conditions of use of this website and will not hold GDPMDS.COM or its associated organisation and personnel liable for any loss or discomfort.

Deadline for Wholesaler and Importer Licences :

31 July 2010