Good Distribution Practice for Medical Device (GDPMD)
What is Good Distribution Practice for Medical Device (GDPMD) ?
GDPMD specifies the requirements for a quality management system to be established, implemented and maintained by an establishment of medical device importer/distributor/ authorized representative to comply with Malaysian Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. The objective of GDPMD is to ensure the quality, safety and performance of medical device 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.
Benefits of GDPMD
GDPMD drives best practice and helps organizations:
Savings in cost from reduction of defects and rejects.
Meet regulatory requirements and customer expectations.
Consistency to proper storage, handling, distribution and traceability.
Demonstrate ability to produce safer and more effective medical devices.
Why CI International?
We has been operating in Malaysia since year 2000 for last 20 years.
We are the no. 3 local certification body in QMS certification accredited by Department of Standard Malaysia.
We provide value added, high integrity, reliable and professional certification services locally and internationally despite reasonable fees.
We have a team of highly and widely experienced lead assessors that know the industries and capable of providing value added audit findings and recommendations for improvement of your organisation management system and business performance.
Click here to download Application Questionnaire for certification application.