GDPMD
The Good Distribution Practice for Medical Devices (GDPMD) is developed to elucidate the requirements for an appropriate management and control of these activities. It is an enforcement by The Medical Device Authority (MDA) of Malaysia where all the organizations involved in the supply chain of medical devices to acquire a Good Distribution Practice for Medical Devices (GDPMD) certification, which is in compliant with Malaysian Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012.
This is to establish proper management and monitoring of end-to-end supply chain of medical devices. The supply chain stakeholders must establish, implement and maintain a Quality Management System (QMS) to ensure that the safety and performance of the device is properly managed till it reaches the end user or Point of Care (PoC).

Who?
Is this for you?
Organizations involved in below activities shall obtain GDPMD
- Import
- Storage & handling
- Warehousing
- Secondary assembly
- Distribution (Including transportation)
- Installation, testing & commissioning (Including the required facilities)
- Maintenance and calibration (Including the required facilities)
- Documentation (Including traceability of medical devices)
Why?
Benefits for your business
GDPMD drives best practices 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.
The Key Elements of GDPMD
Organization and GDPMD Regulatory Compliance System
Establishment Responsibilities
Resource Management
Supply Chain and Device Specifications
Surveillance and Vigilance
How can Aegis Support?
One-to-one Consultation Modelling
Allow us the opportunity to better understand your needs and expectations.
Buzz us for the complimentary 1-1 private consultation with the consultant.
Identifying Gap & Awareness
We identify the gaps within your organization against the international standards and ensure your team members do not just implement the system but able to sustain it for continual improvements (even after being certified).
Documentation Preparation & Implementation
We design and customize documentation that suits your business needs. We want to ensure and prepare you ahead with the right steps for effective implementation.
Internal & External Audit
We review and ensure the established Management Systems are in compliance with international standards prior to internal and external audits. We support your organization up to successful certification.
Get Certified and Showcase
Impress your stakeholders with your achievement!