MDA/CAB-019 Registered

Medical Device
Certification Experts

ASI Certification Sdn. Bhd. is a trusted Certification Assessment Body recognized by the Medical Device Authority of Malaysia, helping organizations achieve regulatory compliance and certification excellence.

Explore Services Our Certifications
✔ MDA Registered ✔ ISO 13485 ✔ GDPMD Certified
Medical Certification
MDA
Registered CAB
28+
Certification Scopes
Certification Services

Regulatory Compliance, Simplified.

We deliver comprehensive conformity assessment and certification services for medical device manufacturers, distributors, and healthcare organizations.

Our Credentials

Officially registered with the Medical Device Authority Malaysia, ensuring the highest standards in medical device certification.

MDA

Registered CAB

28+

Technical Scopes

Qualified

MDA Auditors
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ISO 13485 Certification

Quality management system certification for medical devices with complete documentation review, internal audits, and certification assessments.

GDPMD Certification

Good Distribution Practice certification ensuring quality standards throughout the medical device supply chain.

Product Verification

Conformity assessment and verification services for all classes of medical devices approved in recognized countries.

Technical Area Assessment

Full conformity assessment across imaging systems, IVD devices, respiratory devices, surgical instruments, and more.

Certification Scopes

Our Accreditation Coverage

ASI Certification offers comprehensive conformity assessment services across multiple medical device categories.

Good Distribution Practice for Medical Devices
GDPMD
Quality Management System for Medical Devices
ISO 13485
MD 0101 - Non-active devices for anesthesia and respiratory care
MD 0102 - Non-active devices for injection and transfusion
MD 0105 - Non-active orthopedic and rehabilitation devices
MD 0106 - Non-active medical devices with measuring function
MD 0110 - Non-active instruments
MD 0115 - Dental devices and accessories
MD 0120 - Devices for stimulation and inhibition
MD 0130 - Active surgical devices
MD 0140 - Active therapeutic devices
MD 0150 - Imaging devices using ionizing radiation
IVD 0200 - Molecular biology and microbiology devices
IVD 0205 - Specimen receptacles and diagnostics

Conformity Assessment by Way of Verification

ASI Certification is qualified to perform product verification for medical devices that are already approved in recognized countries. This includes conformity assessments for all classes of devices in accordance with regulatory requirements.

Why Choose Us

Built on Trust & Excellence

We are committed to maintaining the highest standards in medical device certification with qualified auditors and trusted regulatory expertise.

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MDA Registered CAB

Officially recognized and registered as a Conformity Assessment Body by the Medical Device Authority Malaysia.

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Qualified Auditors

Our team includes competent auditors registered with the Medical Device Authority Malaysia.

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Reputable Standards

We maintain the highest possible standards in all certification and conformity assessments.

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Continuous Improvement

We continuously improve our processes to better serve healthcare organizations and manufacturers.

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Comprehensive Scope

Coverage across active devices, IVD, imaging systems, respiratory equipment, and specialized instruments.

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Supply Chain Support

End-to-end audit and certification support across the medical device supply chain ecosystem.

Get In Touch

Ready to Get Started?

Whether you need certification guidance or equipment compliance support, our team is here to help.

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Address
Upper Floor, 87 Jalan Nilam 1/2, Subang Hi-Tech Industrial Park, 40000 Shah Alam, Selangor
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Phone
+603-5621 0358
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Email
admin@asicertification.com