The Path to GDPMD Certification
In the medical device industry, ensuring safety and performance of medical devices throughout the distribution chain is of paramount to achieve the goal of protecting public health and safety. In Malaysia, the Medical Device Authority (MDA) has established requirements for Good Distribution Practice for Medical Devices (GDPMD). Compliance with GDPMD is a basic requirement for the application of an establishment license for medical devices. Companies seeking to distribute medical devices in Malaysia must adhere to the GDPMD standards to ensure the proper handling, storage, and distribution of these medical devices. GDPMD certification is a key milestone for companies operating in Malaysia, signaling their commitment to compliance with GDPMD regulatory requirements. This article explores the requirements to be certified GDPMD and highlights the significance of this certification in the Malaysian regulatory framework.
What are the requirement for GDPMD?
The requirement to be certified GDPMD consist of 6 parts as outlined by the Medical Device Authority (MDA). These parts provide a structured framework for companies seeking certification and compliance with Good Distribution Practice for Medical Devices (GDPMD) in Malaysia:
Part 1: Preliminary
This section typically covers introductory elements, setting the foundation for GDPMD compliance. Key aspects may include: the scope of the GDPMD Regulatory Compliance System within the organization and understanding and acknowledging the relevant legal and regulatory requirements.
Part 2: Organization and GDPMD Regulatory Compliance System
This part focuses on the overall structure and design of the GDPMD Regulatory Compliance System. It outlines the structure and system within the organization, covering roles and responsibilities, as well as procedures for documents control and record keeping to ensure compliance with GDPMD regulations.
Part 3: Establishment Responsibilities
This section covers the specific responsibilities related to the establishment and maintenance of the GDPMD Regulatory Compliance System within the organization. It includes ensuring that personnel are adequately trained and competent to perform their roles and also outlining the mechanisms for regular management reviews.
Part 4: Resource Management
This part addresses the allocation and utilization of resources to support GDPMD compliance within the organization. This included personnel, infrastructure and work environment, ensuring that organizations have the necessary resources for the implement and maintenance of GDPMD Regulatory Compliance System.
Part 5: Supply Chain and Device Specific
This section focusses on the practical aspects of distribution, the supply chain and requirements for specific medical devices, including active and implantable medical device. In this part will cover proper handling of incoming stock, condition for storage and transportation of medical devices and implementation of systems for identifying and tracing devices throughout the supply chain. Additionally, it covers the control of nonconforming medical devices including returned medical devices and outlines procedures for the proper disposal of medical devices.
Part 6: Surveillance and Vigilance
This part emphasizes the post-market activities within the supply chain, highlighting the continuous monitoring and reporting mechanisms for surveillance and vigilance within the GDPMD Regulatory Compliance System. It involves management of medical device complaints, Field Corrective Action (FCA) and Field Safety Notice (FSN), along with any recalls initiated by the manufacturer or Authorized Representative (AR). Additionally, establishing protocols for reporting any adverse events and implementing corrective and preventive actions. This system also encourages the regular conduct of internal audits to promote a culture of continuous improvement.
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Conclusion
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