Industry Expert Learning Series HRDF SBL Claimable
Understanding & Implementing Good Distribution Practice for Medical Devices (GDPMD) in Malaysia
INTRODUCTION GDPMD is a stipulated requirement under the Malaysian Medical Act and its accompanying Regulations affects parties involved in the distribution of medical devices (authorized representatives, importers & distributors). This course provides a thorough introduction and interpretation of GDPMD and related guidelines.
Participants will be led by an experienced tutor with over 2 decades of auditing, training and quality assurance as well as management system development experience – including experience in assisting organisations in the implementation of GDPMD. Participants will gain proficiency on GDPMD and know how to develop, implement and maintain GDPMD system in their organisations.
Overview of the Malaysian Medical Device Regulation Framework – MD Act & Regulations 2012
Organization & GDPMD Regulatory compliance system
Responsibilities of AR, Distributor and Importer
Supply Chain & Device Specific requirements
Surveillance & Vigilance
Strategy towards development and implementation of GDPMD
Understand the structure of the Malaysian Medical Device legislature
Link the relationship between GDPMD and appreciate its impact on the medical device supply chain at the Placement on Market and Post Market stages
Understand requirements & structure of the Regulatory Compliance Manual
Understand requirements for Document & Records Control
Understand human resource requirements for GDPMD compliance
Understand requirements for Internal Audits and Management Reviews appropriate for GDPMD
Understand how to determine competency requirements, how to bridge such gaps including evaluating the effectiveness of such actions plus maintenance of resulting records
Understand requirement for Infrastructure, Work Environment as well as GDPMD specific requirements on Cleanliness & Pest Control
Understand requirement for selection, calibration and maintenance of Measuring & Test Equipment
Learn the importance of and requirements for proper format & content of Letters of Authorization
Understand Stock Management, Traceability and Delivery requirements under GDPMD including controls over nonconforming medical devices and disposal.
Understand requirements for management control over Outsourced activities
Understand what is considered Secondary Assembly and what management program is require
Understand compliance requirements with regards to Active Medical Devices
Understand the roles & responsibilities the Manufacturer, Importer & Distributor (together with required actions) with regards to Counterfeit, Adulterated, Unwholesome and Tampered Medical Devices; Complaint Handling; FCA / FSN; recalls; and Mandatory Problem Reporting
Regulatory Affairs Managers
Auditors of Medical Device supply chain firms (internal and external)
Cross functional team members of implementation project
Those responsible for GDPMD in organizations assuming either the roles of Local Authorised Representatives, Importers or Distributors.
PRE-REQUISITES Basic understanding of the Medical Devices and/or ISO 13485 2003 is preferred
DURATION Two (2) full days
CONTACT For enquiries, please email to firstname.lastname@example.org. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347