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Safety Environment


Safety Environment


Understanding GDPMD Regulatory Requirements

Understanding GDPMD Regulatory Requirements

Duration (Days)



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

  • 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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