MMD-124    An Overview of Good Distribution Practice for Medical Devices (GDPMD)
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• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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In line with Malaysia’s Medical Device Regulation 2012, compliance with Good Distribution Practice for Medical Devices (GDPMD) is essential for all authorized representatives, importers, and distributors. This practical one-day programme provides a comprehensive interpretation of GDPMD clauses, guiding participants through each requirement to ensure clear understanding and effective implementation.

Through structured explanations, real-life examples, and interactive discussions, participants will gain practical insights into regulatory expectations, the relationship between GDPMD and Quality Management Systems (QMS), and how to establish and maintain a compliant regulatory framework within their organization.

Designed for professionals involved in regulatory compliance, quality assurance, and operations within the medical device supply chain, this course equips you with the knowledge and confidence to strengthen your compliance system and successfully meet GDPMD standards.
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Upon completion of this programme, participants will be able to:

• Understand the fundamentals of GDPMD and its regulatory importance.
• Interpret GDPMD requirements (Part 1–6) in practical distribution scenarios.
• Identify regulatory expectations and compliance requirements for establishments.
• Explain the relationship between GDPMD, QMS, and medical device registration.
• Apply GDPMD best practices to support compliance and audit readiness.

• Module 1: Introduction to Medical Devices & GDPMD
• Module 2: GDPMD Part 1 & Part 2 – Preliminary & Regulatory Compliance System
  
• Module 3: GDPMD Part 3 & Part 4 – Establishment Responsibilities & Resource Management
  
• Module 4: GDPMD Part 5 & Part 6 – Supply Chain, Surveillance & Vigilance
  
• Module 5: GDPMD Implementation & Industry Practices

This course is designed for individuals in the medical device local authorized representative, distributor and importer who are involved in the development and maintenance of a quality management system based on GDPMD.

This is a 1-day programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.