Our Hotline+603 - 8230 0300

fas fa-search
Loading...

Folder Guideline Documents

Documents

Toggle Title Date
pdf Guideline For Re-Registration Of Registered Medical Device.pdf ( pdf, 326 KB ) (21328 downloads) Popular
pdf Guideline For Registration of COVID 19 IVD Test Kits ( pdf, 601 KB ) (4454 downloads) Popular
pdf Guideline for Registration of Drug Medical Device and Medical Device Drug Combination Products 3rd Edition 15th September 2020 (003) ( pdf, 1.26 MB ) (8538 downloads) Popular
pdf GUIDELINE FOR REGISTRATION OF DRUG MEDICAL DEVICE AND MEDICAL DEVICE DRUG COMBINATION PRODUCTS 4TH EDITION ( pdf, 1.09 MB ) (3138 downloads) Popular
pdf GUIDELINE FOR REGISTRATION OF DRUG MEDICAL DEVICE AND MEDICAL DEVICE DRUG COMBINATION PRODUCTS 4TH EDITION ( pdf, 1.09 MB ) (14470 downloads) Popular
pdf Guideline For Registration of Drug Medical Device and Medical Device Drug Combination Products Second Edition 20 June 2019 ( pdf, 852 KB ) (11770 downloads) Popular
pdf Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combinations Products ( pdf, 1.03 MB ) (12954 downloads) Popular
pdf Guideline of Product Classification FINAL ( pdf, 503 KB ) (6015 downloads) Popular
pdf Guideline uupdate on 24 May 2021 v2 ( pdf, 426 KB ) (6275 downloads) Popular
pdf Guidelines on Medical Device Registration Under Act 737 (MDA/GL/MD-01: JUNE 2014 2nd Edition) ( pdf, 518 KB ) (176154 downloads) Popular
pdf How to apply for establishment License under medical device act 2012 ( Act 737) V2 ( pdf, 376 KB ) (54205 downloads) Popular
pdf How to Apply for In-Vitro Diagnostic (IVD) Medical Device Registration under Medical Device Act 2012 ( pdf, 414 KB ) (52466 downloads) Popular
pdf HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012-Third edition.pdf ( pdf, 1.12 MB ) (20778 downloads) Popular
pdf MDA GD0026 Requirement on Labelling of MD 3rd Ed ( pdf ) (20553 downloads) Popular
pdf MDA GL 08 Re registration guideline ( pdf, 329 KB ) (10756 downloads) Popular
pdf MDAGD0016 Notification for Clinical Research or Performance evaluation ( pdf, 1.33 MB ) (18489 downloads) Popular
pdf MDAGD0020 Change Notification 3rd Ed November 2018 ( pdf, 514 KB ) (33295 downloads) Popular
pdf MDAGD0045 CFS for EO MD Nov2018 ( pdf, 475 KB ) (10719 downloads) Popular
pdf Pekeliling bil 1 Tahun 2022_BM_Obsolete.pdf ( pdf, 807 KB ) (3914 downloads) Popular
pdf Pekeliling bil 1 Tahun 2022_Eng_Obsolete.pdf ( pdf, 746 KB ) (3924 downloads) Popular

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

SPLASK Multilang Active
Accessibility Tag Active
Dasar Privasi
Medical Device Act 2012 (English) Lawatan Regulatori ke UAE - Mei 2025 Maklumat CIO KKM HRMIS MeDC@St 2.0

Today 1708 Yesterday 34367 Week 1708 Month 504575 Visitor Counter: 134963966

  • Last Updated: 16 April 2026.

Copyright © 2023 - 2026 Medical Device Authority
Ministry of Health Malaysia
Best view with Firefox 64 and above, minimum resolution 1366x768
Maximize
Chat Now