GDPMD AND PRODUCT REGISTRATION

GDPMD Certification, Establishment License and Product registration are two regulatory requirements for Medical Device Industry player. Started from July 2012 until closing date July 2015, all company affected required to ensure fulfillment of the said requirement or potentially face legal action base on the requirements of Medical Device Act 737.

GDPMD Certification is a design of system that designated for medical device distribution supply chain to ensure product safety and performance of devices throughout the distribution cycle.

Apart from that, the GDPMD will also ensure the company involved shall retain the necessary procedures and protocol of pre and post sales activity.

GDPMD will also help to ensure of prevention of counterfeit adulterate, unwholesome and tampered medical devices being supplied within the same supply chain. This will ensure only good products are supplied to end users.

For LAR (Local Authorised Representative), the additional requirement for the compliance of GDPMD will be the Product Registration of devices.

Product Registration will involve of the company to fulfill the Conformity Assessment such as the technical product summary by compiling technical file and producing the technical summary called the CSDT (Common Submission Dossier Template).

CSDT is a compiled of technical information, in a summary form, base on the designated CSDT documents requirement of Medical Device Authority of Malaysia and must be submitted for Product Evaluation by CAB.






For more information of the above, Kindly contact us at 03 7832 3502/4502 Ummah Synergy Resources.