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Good Distribution Practice for Medical Device

GDPMDs certification is generally needed for companies dealing with importation or distribution of medical devices in Singapore, Malaysia and others. It can be achieved after the company’s Quality Management System is certified by a certification body.

What is it?

Importers and wholesalers dealing with medical devices in Singapore should develop a Quality Management System (QMS) that conforms to the requirements of the Good Distribution Practice for Medical Devices (GDPMDs). GDPMDs ensures that companies dealing with medical devices have quality management systems in place to maintain devices quality throughout the distribution process.

In order to comply with these requirements, a highly articulated process must be established to ensure the medical device safety and performance is not compromised during the importation, storage and distribution of medical devices. This would involve drafting specific clear and unambiguous procedures, training qualified personnel, maintaining the right infrastructure and ensuring the processes are well-planned and implemented.

Benefits of having GDPMDS Certification to Organisation

  • Enhancement of product quality which increases consumer confidence

  • Ensuring business activities are not interrupted by non-compliance of regulations​​

  • Optimizing supply/distribution chain and increase efficiency & productivity

  • Eligibility to attain an Importer / Wholesaler’s license from HSA Singapore

Benefits of having GDPMDS Certification to Customers

  • Improved quality and service​​

  • Establishes trust and credibility to customers​​

  • Reduced customer audits​​

  • Independent audit demonstrates a commitment to quality​​

  • Shorten the selection process by being conforming to the required standards

Get in touch with us.

Our consultants at QuikQuality has helped many companies in achieve Good Distribution Practice by streamlining and drawing on existing resources. Contact us for more information on the pricing and procedures!

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