GDPMD HomeCompanies that are involved in wholesaling and/or importing Medical Devices in Malaysia are required to implement a quality management system and obtain GDPMD certificate to applying for licence for their establishment.
Medical devices companies are required to implement quality management system which include procedures and provide suitable facilities and people to handle the medical devices and keep accurate and timely records 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 GDPMD quality management system or can employ GMP/GDP consultant to assist. The latter may 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 system to “give assurance”. This may include appropriate procedures, suitably trained and qualified personnel, correct processes / facilities / equipment as well as clear and timely records and 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 GDPMD (draft) requirements. However there are differences between ISO 9001:2008 and GDPMD (draft) which companies will need to reconcile before going for the audit. In addition, companies who have implemented similar quality management system in other countries may not be 100% compliant as the requirements are not identical. Currently there is no mutual recognition agreement between Malaysia and other countries on this topic.
Companies are encourage to prepare early and be ready to apply for their licence before the mandatory deadline (to be announced soon) to avoid a last minute panic and potential business interruption. Companies who have not implemented a system which complies with the GDPMD requirements will need time to implement the system, generate records through the normal business process and test out their systems. Depending on the nature of the business, this could take several months. Having a well-designed quality management system will give you consistent product and service quality, efficiency and cost benefits as oppose to a poorly designed one which will become a burden to your business.
Lastly, if you decided to use a consultant, think long term, make sure the consultant has genuine track records, able to continue to support your business in the future, keeping you in compliant with the regulations, able to help you to solve regulatory problems if an adverse event happens. Consulting cost should not be your only consideration, you should consider the opportunity cost if you were to develop one yourself, cost to maintain the QMS and cost related to business continuity.