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About Genuine Diamond Sdn. Bhd.

Conformity Assessment Body (CAB) One Stop Centre.

GENUINE DIAMOND SDN. BHD. (GDSB) determines to be a Conformity Assessment Body (CAB) “One Stop Centre” for Certifications including Quality Management Systems for Medical Devices (ISO 13485), Good Distribution Practice for Medical Devices (GDPMD) and Product Registration for Conformity Assessment for Medical Devices & In-Vitro Diagnostic Medical Devices (IVD). This certification is applicable to Manufacturers, Authorise Representatives (AR), Importers and Distributors of medical devices in Malaysia. Our objective is to comply with relevant regulatory requirements and continually improve the effectiveness of Quality Management System (QMS). We provide the highest quality services and customer satisfaction with GDSB professional team.

Trusted and Credible
100%
Quality and Reliable
100%
300

Satisfied Establishments

Applications Approved by Authority

1000

Genuine Diamond Sdn. Bhd.

Why choose us

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Licensed by Medical Device Authority

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Over 37 Technical Codes of Medical Devices

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Specialising in In-Vitro Diagnostic Medical Devices

We have over 37 technical codes of medical devices

Genuine Diamond Sdn. Bhd.

Trusted and Credible

To become a trusted and credible Conformity Assessment Body in Malaysia and worlwide.

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Genuine Diamond Sdn. Bhd.

Quality and Reliable

To provide a quality and reliable certification and conformity assessment services (on the safety and performance) for the medical devices to enhance the industry and users well-being.

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Genuine Diamond Sdn. Bhd.

Our Services

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Quality Management System for Medical Devices (ISO 13485)

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Good Distribution Practice for Medical Devices (GDPMD)

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Full Conformity Assessment

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Conformity Assessment by Way of Verification

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