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Assurance safety and performance of Medical Devices
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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.
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Contact |
SIRIM QAS International Sdn. Bhd.
Building 8, SIRIM Complex,
1, Persiaran Dato' Menteri, Section 2,
P.O. Box 7035, 40700 Shah Alam
Selangor Darul Ehsan, MALAYSIA.
Tel: 603 5544 6400 Fax: 603 5544 6810
Website: www.sirim-qas.com.my
Email: cserviceqas@sirim.my |
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