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Understanding GDPMD Regulatory Requirements

Understanding GDPMD Regulatory Requirements

Duration (Days)

2

Overview

This course is designed for Medical Devices industry. Participants will learn about the ACT737 and GDPMB regulatory throughout the course.

Objectives

  • Understand the ACT 737 and its subsidiary legislations.

  • Interpret and apply the GDPMD regulatory requirements.

Course Outline

  • Malaysian Medical Devices Regulatory Framework

  • GDPMD regulatory requirements

  • Organization & GDP regulatory compliance system

  • Documentation and document control 

  • Responsibility & authorities, management review

  • Resource management

  • Infrastructure & work environment, cleanliness and pest control

  • Supply chain & device specific

  • Authorization, communication channels, receipt of stock, storage & stock handling, stock rotation, delivery to dustomers

  • Control of nonconforming devices and disposal, traceability, specific requirements for active medical devices.

  • Secondary assemble including repackaging

  • Surveillance and vigilance

  • Distribution records, PMS, medical device complaint, FCA, FSN, recall, mandatory problem reporting.

  • Internal audits, corrective action, preventive action.

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