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.

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.
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What is GDPMD?
A crucial component of the integrated supply chain for medical devices is distribution. To assure the performance and safety of medical devices at the point of use, a variety of people and entities are generally in charge of the transportation, storage, installation, product sourcing, procurement, delivery, device tracking, commissioning, servicing, and maintenance. Although, there are cases where an individual or organisation is only accountable for and active in a small portion of the distribution process. The dangers involved with these activities could be on the level with others in the manufacturing environment, and the lack of control over them could impact the devices' performance and safety. The Good Distribution Practice for Medical Devices (GDPMD) was developed to clarify the requirements for adequate administration and management of these operations.
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.
Who does GDPMD apply to?
GDPMD applies to the organization that wishes to trade and supply medical devices in Malaysia.
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.
Should I get certified?
Certification to GDPMD is a prerequisite as mentioned in Medical Device Act 2012 (Act 737).
How long is the process?
With a clear understanding and the proper preparation of what is required for the GDPMD requirement and MDA regulations, most organizations can expect certification within 3 to 6 months, depending on the medical device (category) they supply.
What is the cost?
The cost of consultation and certification varies depending on your certification scope, the complexity of the process and company/organization size. There is an additional cost where organization shall register their medical device with Medical Device Authority. The charges are from the authority.

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 consultation
  • 3Introduction 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.
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