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GDPMD Good Distribution Practice for Medical Devices

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What is GDPMD?

 

It is required that a medical device distributor, importer, or authorized representative establish, implement, and maintain a quality management system to comply with the Malaysian Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012.

 

The purpose of GDPMD is to guarantee the effectiveness, safety, and quality of the medical device. Transportation and delivery, product sourcing and procurement, storage, installation, commissioning, service and maintenance, calibration, and post-sale services are just a few examples. Tracking, documentation, and record-keeping procedures are all covered. For purposes of applying for an establishment license, businesses engaged in the wholesale and import of medical devices into Malaysia must implement and receive a GDPMD certificate.

 

Benefits of GDPMD

 

 

  • Meet regulatory requirements and customer expectations.

 

  • Consistency of proper storage, handling distribution and traceability.

 

  • Demonstrate ability to produce safer and more effective at point of use of medical devices.

 

  • Improve operation efficiency through continual improvement process.

 

  • Provides assurance to stakeholders through certification that the organization is able to maintain the quality, safety and performance of medical devices.

The Certification Process

 

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Let us answer you

Frequently Asked Questions

What is GDPMD?
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The Medical Devices Act of 2012 (Act 737) mandates that the Good Distribution Practices for Medical Devices apply to all businesses (GDPMD). Companies in the medical device supply chain are required to develop, put into place, and maintain a quality management system. The certification attests to a facility's competence to maintain the functionality, security, and caliber of the medical equipment it is responsible for. The standard includes representatives of foreign manufacturers, importers, and distributors of medical devices in Malaysia.
Who does GDPMD apply to?
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Organizations that intend to supply and trade medical devices in Malaysia must comply with GDPMD.
Should I get certified?
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According to the Medical Device Act of 2012, certification to GDPMD is a requirement (Act 737).
Suitable for which organization ?
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Any organization, large or small, regardless of its field of activity or products and services it provides, can get GDPMD certified.
If my organization already being certified by others certification body , can we transfer to KIWACERT ?
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Yes of course, we can transfer & continue your certification with NO GAP in your certificate validity. Also , we won't charge you extra on the transfer registration.
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Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

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2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.

Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Information

About KiwaAccreditationBusiness ExcellencePublic InformationMR ClubBlogs

Services

CertificationAcademy

Accredited to ISO/IC 17021:2015

A Simple Image
A Simple Image

ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.

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