Authorized Medical Device Regulatory Compliance & Certification across Malaysia.
GSI is an approved Conformity Assessment Body (CAB) recognised by the Medical Device Authority (MDA), Ministry of Health Malaysia.
We are authorised to perform conformity assessments in accordance with applicable Malaysian medical device regulatory requirements, delivering independent, rigorous, and reliable evaluation services.
Our assessors comprise experienced medical doctors, biomedical engineers, and industry professionals with extensive hands-on expertise in manufacturing, servicing, and regulatory compliance.
100%
MDA Compliant
CAB
Approved Status
Supporting manufacturers, authorised representatives, importers, and distributors operating within Malaysia.
Comprehensive certification for Medical Device Quality Management Systems ensuring global standard alignment.
Expert assessment for Good Distribution Practice for Medical Devices, mandatory for importers and distributors.
Technical evaluation for Active Medical Devices and In-Vitro Diagnostic (IVD) products for MDA submission.
Independent, rigorous evaluation services as an MDA-authorised Conformity Assessment Body.
GSI Regulatory Standard
Connect with our team of medical doctors and biomedical engineers to navigate the Malaysian regulatory landscape with confidence.