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Guidance Document under Medical Device Act 2012 ( Act 737) 

These Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following;

a) Medical Device Act 2012 (Act 737); and

b) Medical Device Regulations 2012.

List of guidance documents:  

Code Title Download 
 MDA/RR NO. 1 Good Distribution Practice for Medical Devices (GDPMD) Click Here
 MDA/GD/0001 In-Vitro Diagnostic (IVD) Medical Device Classification System  Click Here
 MDA/GD/0002 Essential Principles of Safety and Performance of IVD Medical Devices Click Here
 MDA/GD/0003 Principles of Conformity Assessment for In- Vitro Diagnostic (IVD) Medical Devices Click Here
 MDA/GD/0004 Common Submission Dossier Template (CSDT) of In- Vitro Diagnostic (IVD) Medical Device Click Here
 MDA/GD/0005 Product Grouping Click Here
 MDA/GD/0006 Definition of Medical Device Click Here
 MDA/GD/0007 The Essential Principles of Safety and Performance of Medical Devices Click Here
 MDA/GD/0008 Common Submission Dossier Template (CSDT) Click Here
 MDA/GD/0009 Rules of Classification for General Medical Devices Click Here
 MDA/GD/0029 Good Refurbishment Practice of Medical Devices (GRPMD) Click Here
 MDA/GD/0025 Declaration of Conformity (DoC) Click Here
 MDA/GD/0027 Licensing for Establishment Click Here
 MDA/GD/0026 Requirements for Labelling of Medical Devices Click Here
 MDA/GD/0041 Change of Ownership for Medical Device Registration Click Here
 MDA/GD/0020 Change Notification for Registered Medical Device Click Here
 MDA/GD/0016 Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation Click Here
  Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products Click Here
 MDA/GD/0024 Requirements for Export Permit Click Here
 MDA/GD/0031  Conformity Assessment for Medical Device Click Here
 MDA/GD/0018  Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education Click Here
Last Updated ( Friday, 13 April 2018 )
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