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.
Malaysian Medical Devices Regulatory Framework
GDPMD regulatory requirements
Organization & GDP regulatory compliance system
Documentation and document control
Responsibility & authorities, management review
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.