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GDPMD / Good Distribution Practice for Medical Devices

What is 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.

What is the purpose of GDPMD?

The aim of GDPMD is to ensure that companies dealing with medical devices have a quality distribution system in place. This ensures that the quality of the medical devices is maintained throughout the storage and distribution process. The certification to GDPMDS is a mandatory requirement in the application of an Importer's or Wholesaler's Licence.

Why you need to implement and certify GDPMD?

1) A licence to trade in the logistics and shipping of medical devices
2) Develop consistent product or service quality, efficiency and cost benefits

What are the benefits of GDPMD?

1) Medical devices are appropriately managed and controlled throughout the supply chain thus ensuring their safety and performance at the point of use.
2) Provides assurance to stakeholders through certification that the organization is able to maintain the quality, safety and performance of medical devices while under its custody.
3) Fulfillment of establishment licensing requirements.

Why PSV?

We are accredited by the Department of Standards Malaysia (STANDARDS MALAYSIA) and the Accreditation Service For Certifying Bodies (Europe) Limited. Our collaboration with the International Certification Network and networking with foreign Certification Bodies and associated international certification organizations leads to worldwide market access. Our highly experienced and professional auditors are competent in a wide range of sectors. We offer the option of combined certification audits of two or more management systems (Quality, Environmental and Occupational Health and Safety)to minimize disruption to your organization.

“Necessary certification, trade in your target markets, assurance you need anywhere in the world”