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Guidelines for the implementation of medical device regulatory system under Medical Act 2012 (Act 737)


Guidelines are prepared to assist medical device industries during implementation of medical device regulatory system.

List of guidelines are as follow: 

MDA/GL/MD-01   How to Apply for Medical Device Registration Under  Medical Device Act  2012 (Act 737) Third Edition
MDA/GL No. 2   How to apply for establishment License under medical device act 2012 ( Act 737)
MDA/GL No. 2   How to Apply for Apply for In-Vitro Doagnostic (IVD) the Medical Device Registration under Act 737
MDA/GL/04  Application For Medical Device Advertisement Approval - Requirements (2nd Edition)
MDA/GL/05  Conditional Approval For COVID-19 Self-Test Kit 
5th Edition Guideline For Registration Of Drug-Medical Device And Medical Device- Drug Combination Products

MDA / GL / 07

 Guideline for Registration of COVID 19 IVD Test Kits

MDA/GL/08 Guideline For Re-Registration Of Registered Medical Device
MDA/GL/09  Guideline For Registration of Orthopoxvirus (MONKEYPOX) IVD Test Kits
MDA/GL/10 Guideline on How To Submit An Application For Registration Of A Refurbished Medical Device


Updated:  7 Julai 2023


  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 

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  • Last Updated: 29 November 2023.
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Ministry of Health Malaysia
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