Good Distribution Practice – Medical Devices

Good Distribution Practice – Medical Devices

About the Good Distribution Practice for Medical Devices

The Good Distribution Practice for Medical Devices (GDPMD) specifies that a quality management system shall be established, implemented and maintained by an establishment carrying out activities in the medical Devices Act 2012 (Act 737). It requires an establishment to demonstrate its ability to maintain the quality, safety and performance of medical while its custody. It is applicable to all parties involved in the supply-chain of medical devices covering authorized representatives of foreign manufacturers, importers and distributors of medical devices in Malaysia

What are the benefits of Good Distribution Practice for Medical Devices ?

  • Medical devices are appropriately managed and controlled throughout the supply chain thus ensuring their safety and performance at the point of use.
  • Provides assurance to stakeholders through certification that the organization is able to maintain the quality, safety and performance of medical devices while under its custody.
  • Fulfillment of establishment licensing requirements.

Why SIRIM QAS International ?

  • We are accredited by the Department of Standards Malaysia (STANDARDS MALAYSIA) and the United Kingdom Accreditation Service (UKAS).
  • Our collaboration with the International Certification Network, IQNet and networking with foreign Certification Bodies and associated international certification organizations leads to worldwide market access.
  • Our highly experienced and professional auditors are competent in a wide range of sectors.
  • We offer the option of combined certification audits of two or more management systems (Quality, Environmental and Occupational Health and Safety) to minimize disruption to your organization.

How to apply the Good Distribution Practice for Medical Devices ?

  1. Submission of Questionnaire and Appendix
  2. Issuance of Quotation
  3. Submission of Application
  4. Stage 1 Audit
  5. Stage 2 Audit
  6. Recommendation & Approval
  7. Issuance of Certificate

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