How To Apply GDPMD License In Malaysia

What Is A GDPMD License?

It is a key priority for the Medical Device Authority (MDA) of Malaysia to maintain and improve the safety, quality assurance and performance throughout the medical device supply chain.

Therefore, they require all medical devices to be registered and all stakeholders, which includes manufacturers, importers, exporters, distributors and service providers involved in the supply chain of medical devices to be licensed and have a GDPMD (Good Distribution Practices for Medical Device) in place.

The main objective of GDPMD Certification is to ensure proper management and monitoring of the end-to-end supply chain of medical devices, and stakeholders are vigilant to verify the safety, quality and performance assurance of medical devices to safeguard the health interests of the general public.

As part of these requirements, the QMS (Quality Management System) such as ISO 13485 is required for supply chain stakeholders in Malaysia to implement and maintain so that the safety and performance of the device are intact until it reaches the end-user or Point of Care (PoC).

Benefits Of Having A GDPMD License

GDPMD License drives best practices that will benefit all medical devices supply chain stakeholders and end-users.

The medical devices’ quality, safety and performance during all aspects of the medical device supply chain are appropriately managed and controlled to ensure safety and performance at the point of use.
All medical devices meet regulatory requirements and customer expectations.
Enforce consistency in proper storage, handling, distribution and traceability.
Improve operational efficiency through continuous improvement processes.
Save unnecessary costs by reducing defects and rejects.
Exhibit ability to produce safer and more effective medical devices.

Who Should Apply for GDPMD License?

All entities, with the exception of manufacturers and merchants, must acquire a GDPMD certificate that has been properly issued by a Conformity Assessment Body (CAB) following a careful inspection.

For producers of medical devices, the GDPMD accreditation is similar to ISO 13485:2016 certification.

The following organisations must obtain a GDPMD licence for their establishments:

Warehousing
Import
Stocking and handling
Distribution (which includes transportation)
Configuration, testing, and commissioning (includes the required facilities)
Second rank assembly
Upkeep and calibration (which includes the required facilities)
Records and documentation (includes traceability of medical devices)

Before submitting an application for GDPMD certification in Malaysia, firms must register with Suruhanjaya Syarikat Malaysia (SSM).

How To Apply for GDPMD License In Malaysia?

Below shows the license application flow for GDPMD in Malaysia:

Complete & Submit the Request for Information (RFI)
Issuance of Quotation
Submit for Application
Stage 1 Document Review
Stage 2 Implementation Audit
Recommendation & Approval
Issuance of Certificate
Surveillance Audit
Recertification Audit (after 3 years)

How Can One Island Consultancy Help You?

Since 2009, we have strived to serve all organisations with value-added, high integrity, reliable and professional certification services locally and internationally despite reasonable fees.

Not only are we able to advise on the importance of GDPMD in the medical device industry and how to apply for GDPMD license, our ISO consultants in Malaysia are also qualified training providers for various certifications.

You can also reach out to us if you’re interested in being certified for:

We take pride in having a body of highly and widely experienced lead assessors who know the industries well and are capable of providing value-added audit findings and recommendations to improve your organisation’s management system and business performances.

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