Trusted since 2015

Conformity Assessment Body (CAB).

Genuine Diamond Sdn. Bhd. delivers certification, conformity assessment, and regulatory guidance for medical devices and IVDs with a focus on quality and credibility.

About Genuine Diamond Sdn. Bhd.

Conformity Assessment Body (CAB).

Genuine Diamond Sdn. Bhd. (GDSB) determines to be a Conformity Assessment Body (CAB) for certifications including Quality Management Systems for Medical Devices (ISO 13485), Good Distribution Practice for Medical Devices (GDPMD), and Product Registration for medical devices and In-Vitro Diagnostic Medical Devices (IVD).

We serve manufacturers, authorized representatives, importers, and distributors in Malaysia with continuous improvement and dependable regulatory compliance.

Trusted and Credible100%
Quality and Reliable100%

500+

Satisfied Establishments

Satisfied

Establishments Served

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Approved by Authority

5000+

Applications Reviewed

Genuine Diamond Sdn. Bhd.

Why choose us

Why choose us 1

Licensed by Medical Device Authority

Why choose us 2

Over 44 Technical Codes of Medical Devices

Why choose us 3

Specialising in In-Vitro Diagnostic Medical Devices

We have over 44 technical codes of medical devices

MDS 7210 - IVDs utilizing material of human originMD 0101 - Non-active devices for anesthesia, emergency and intensive careMD 0102 - Non-active devices for injection, infusion, transfusion and dialysis

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