NEW REVISION FOR REGULATORY REQUIREMENTS FOR MEDICAL DEVICE SAFETY & PERFORMANCE: GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD) MDA/RR NO 1: NOVEMBER 2015 FIRST REVISION

 

This Document was prepared to ensure the quality, safety and performance of medical device during all aspects of medical device supply-chain, which include, but not limited to, product sourcing and procurement; transportation and delivery; storage; installation, commissioning, service and maintenance, calibration and after sales service; tracking, documentation and record-keeping practices.

 This document is the first revision of MDA/RR No 1: July 2013 Good Distribution Practice for Medical Devices. It cancels and supersedes the MDA/RR No 1: July 2013.

This document shall be used starting 2nd November 2015 for conformity assessment on GDPMD.

 MDA/RR NO 1 NOVEMBER 2015 FIRST REVISION: GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)