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Medical Device Authority (MDA) Malaysia (Medical Device Act 2012 (Act 737)…
Medical Device Authority (MDA) Malaysia
About MDA
Mission
To provide regulatory control of medical device industry in Malaysia, through compliance of act by ensuring safety and performance to protect public towards excellence customer satisfaction
Vision
To become excellent medical device regulatory authority recognized globally by 2022
Objectives
a lot objectives, please read at website.
Page contents
Legislations (Laws)
Medical Device Act 2012 (Act 737)
Medical Device Authority Act 2012 (Act 738)
Medical Device Exemption Order 2016
5 more other Acts and orders
Standards
Malaysian Standards
www/msonline.gov.my/catalog.php
Contains collections of Malaysian Standards
International Standards
International Organization for Standardization (ISO) TC standards
International Electrotechnical Comission (IEC) TC Standards
Establishment License Renewal
Medical Device Act 2012 (Act 737)
Definitions of contexts
Registration of Medical device / classification of medical device/ obligations/
Conformity assessment body/
License and Permit
Designated medical device permit
Duties and obligations of licensees or permit holders
Export permits
Documents
Reference
Guideline
Circular letter
Guidance
Post market activities ( reporting of defective/ faulty incidents)