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) applies to all companies carrying out activities, as stated in the Medical Devices Act 2012 (Act 737). The companies involved in the supply chain of medical devices must establish, implement and maintain a quality management system.

The certification ensures an establishment’s ability to maintain the quality, safety and performance of medical devices in its custody. The standard involves parties such as representatives of foreign manufacturers, importers and distributors of medical devices in Malaysia.

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.
  • Assures stakeholders through certification that the organisation can maintain quality, safety and performance of medical devices while under its custody.
  • Fulfilment of establishment licensing requirements.

Why SIRIM QAS International?

  • We have a large pool of experienced and professional auditors that are qualified internationally.
  • The competency of our multi-disciplined auditors adds value and credibility to our certificates.
  • We offer the option of combined certifications of more than one management system to minimise disruption to your organisation.

How to apply the Good Distribution Practice for Medical Devices?

  1. Submission of Request for Information (RFI)
  2. Issuance of Quotation
  3. Submission of Application
  4. Stage 1 Audit
  5. Stage 2 Audit
  6. Recommendation & Approval
  7. Issuance of Certificate
  8. Surveillance and Recertification Audit

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