Good Distribution Practice for Medical Devices Interpretation (GDPMD)

Gdpmd is a stipulated requirement under the malaysian medical device act 737 and its accompanying regulations affects parties involved in the distribution of medical devices. This course provides an introduction and interpretation of gdpmd and related guidelines. 

Participants will gain proficiency on GDPMD development, implement and maintain the GDPMD Quality Management System in their organisations.

Course Objective

• Understand the requirements of GDPMD
• Ensure an efficient and successful medical device quality management system to improve and maintain compliance
• Understand and implement the medical device regulations effectively
• To gain knowledge and skill to establish the GDPMD regulatory system in their organisations

Course Content

• Overview of the Malaysian Medical Device Regulation framework
• Organisation & GDPMD Regulatory compliance system
• Responsibilities of Authorised Representative (AR), Distributor and Importer
• Resource Management
• Supply Chain & Device Specific requirements
• Surveillance & Vigilance
• Strategy towards development and implementation of GDPMD

Target Audience/ Participants

• Designated Persons
• Quality Managers
• Regulatory Affairs Managers
• Auditors of Medical Device supply chain firms (internal and external)
• Cross functional team members of implementation project
• Persons who are responsible for GDPMD in organisations assuming either the roles of local Authorised Representatives, Distributors or Importers