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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:

No.CodeTitle
1 MDA/GL/MD-01 How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737) Third Edition
2 MDA/GL No. 2 How to apply for establishment License under medical device act 2012 (Act 737)
3 MDA/GL No. 2 How to Apply for In-Vitro Diagnostic (IVD) Medical Device Registration under Act 737
4 MDA/GL/04 Application For Medical Device Advertisement Approval - Requirements (2nd Edition)
5 MDA/GL/05 Conditional Approval For COVID-19 Self-Test Kit
6 5th Edition Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products
7 MDA / GL / 07 Guideline for Registration of COVID 19 IVD Test Kits
8 MDA/GL/08 Guideline For Re-Registration Of Registered Medical Device
9 MDA/GL/09 Guideline For Registration of Orthopoxvirus (MONKEYPOX) IVD Test Kits
10 MDA/GL/10 Guideline on How To Submit An Application For Registration Of A Refurbished Medical Device
11 MDA/GL (CAB)/MDRR-01 Guideline For: Conformity Assessment Procedure for Re-Registration of Registered Medical Device by Conformity Assessment Body (CAB)

Updated: 23 Januari 2025