Good Distribution Practice for Medical Devices in Singapore (GDPMDS)
The objective of GDPMDS is to assist in ensuring the quality and integrity of medical device products throughout the distribution process. GDPMDS specifies requirements for a quality system used by an organization for the handling, storage, delivery, installation and servicing, with respect to the medical device products they deal in.
The design and implementation of GDPMDS by an organization is influenced by the size and structure of the organization, the processes employed, and the type of medical device products it deals with.
The certification to GDPMDS is to be conducted by certification bodies accredited by the Singapore Accreditation Council (SAC) and recognized by the Health Sciences Authority (HSA).
What is a Medical Device?
Medical Device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one of more of the specific purposes of
(a) diagnosis, prevention, monitoring, treatment or alleviation of any disease;
(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
(c) investigation, replacement, medication, or support of the anatomy or of a physiological process, etc.
