
We Provide GDPMD Training And Certification In Malaysia
As stated by the Good Distribution Practice for Medical Devices (GDPMD), an establishment of a medical device distributor/importer/ authorised representative must establish, implement, and maintain a quality management system to comply with the Malaysian Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012.
The objective of GDPMD is to ensure the medical device's quality, safety and performance. This includes but is not restricted to transportation and delivery; product sourcing and procurement; storage, installation, commissioning, service and maintenance, calibration and after-sales service; tracking, documentation and record-keeping practices. Organisations involved in wholesaling and importing Medical Devices in Malaysia must implement and obtain a GDPMD certificate to apply for an establishment license.
Why Become GDPMD Certified?
GDPMD applies to the organization that wishes to trade and supply medical devices in Malaysia. Certification to GDPMD is a requirement as stipulated in Medical Device Act 2012 (Act 737).


What Benefits Will It Bring To My Business?
Medical devices are appropriately managed and controlled throughout the supply chain. Thus, ensuring their safety and performance at the point of use.
Assures stakeholders through certification that the organisation can maintain quality, safety and performance of medical devices while under its custody.
Fulfilment of establishment licensing requirements.
- The supply chain for medical devices is adequately managed and regulated. Consequently, their performance and safety at the point of use are guaranteed.
- Reassures stakeholders that the business can maintain the quality, safety, and performance of medical equipment in its care through certification.
- Adherence with licencing regulations for businesses.

Frequently Asked Questions
To comply with Malaysian medical device regulatory requirements as outlined in the Medical Device Act 2012 (Act 737), GDPMD details the requirements for a quality management system to be established, implemented, and maintained by an establishment when carrying out activities in the medical device supply chain.
OR
According to the Medical Devices Act of 2012 (Act 737), all businesses engaged in activities are subject to the Good Distribution Practice for Medical Devices (GDPMD). The medical device supply chain companies must create, implement, and keep up a quality management system.
The accreditation confirms a facility's capability to maintain the performance, safety, and quality of medical equipment under its care. Representatives of international medical device producers, importers, and distributors in Malaysia are included in the standard.
Assures stakeholders through certification that the organisation can maintain quality, safety and performance of medical devices while under its custody.
Fulfilment of establishment licensing requirements.
- The supply chain for medical devices is adequately managed and regulated. Consequently, their performance and safety at the point of use are guaranteed.
- Reassures stakeholders that the business can maintain the quality, safety, and performance of medical equipment in its care through certification.
- Adherence with licencing regulations for businesses.
Steps To Certification
With a good understanding and the right preparation of what is required for the GDPMD requirement and MDA regulations, most organisations can achieve certification within 3 to 6 months depending on the medical device (category) they supply.
1Request for Quotation
Call us now and select a package that fits your budget.2Make Appointment with Our Consultant
Receive your first-round free consultation3Introduction to GDPMD Training
Help your organization to demonstrate commitment towards quality and customer satisfaction.4Documents Preparation & Implementation
Identify documents that are needed for your Quality System and Production or Service Processes; start to implement.5Internal & External Audit
To confirm that your Management System (QMS) is properly established and maintained while meeting the international standard.6Get Certified & Impress Your Client
Show off your certificate on your website and sales collateral.
