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Malaysia MDA Med Dev Guidance: Guide for CABs and Medical Device Establishments
The Medical Device Authority (MDA) of Malaysia has released two important guidance documents, " Guide for Conformity Assessment Bodies...
Sharan Murugan
Apr 13 min read
6 views
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Malaysia MDA Med Dev Guidance: Importation of Medical Devices for Re-Export (IRE)
The Medical Device Authority (MDA) of Malaysia, under the Ministry of Health, has introduced a guidance " Importation of Medical Devices...
Sharan Murugan
Mar 182 min read
7 views
0 comments
Malaysia’s NPRA: Drug Registration Guidance Document (DRGD), 3rd Edition, Ninth Revision January 2025
Malaysia’s Drug Registration Guidance Document (DRGD) is a cornerstone for pharmaceutical compliance. The " Drug Registration Guidance...
Sharan Murugan
Jan 262 min read
58 views
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Malaysia’s NPRA: Guidance for Bioequivalence Inspection
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) published an updated regulatory guidance on the conduct of bioequivalence...
Sharan Murugan
Sep 25, 20242 min read
38 views
0 comments
Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (21 May, 2024) released an updated guideline on " Electronic...
Sharan Murugan
May 25, 20242 min read
81 views
0 comments
Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) released an updated guideline on "Guideline for Application of Clinical Trial...
Sharan Murugan
Mar 29, 20242 min read
71 views
0 comments
Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (13 December 2023) released an updated guidance on "Guidelines for...
Sharan Murugan
Dec 19, 20231 min read
54 views
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Malaysia NPRA: Guidance on Drug Registration
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (26 July, 2023) released an updated guidance on "Drug Registration"...
Sharan Murugan
Jul 30, 20232 min read
278 views
0 comments
Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity
Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...
Sharan Murugan
Jul 12, 20231 min read
130 views
0 comments
Malaysia's Medical Device Authority: Guideline on Medical Face Mask and Respirator
Recently (19 May, 2023) Medical Device Authority (MDA) of the Ministry of Health Malaysia released an updated guidance on "Medical Face...
Sharan Murugan
May 23, 20231 min read
19 views
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Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (11 April, 2023) released an updated guideline on " Electronic...
Sharan Murugan
Apr 18, 20231 min read
71 views
0 comments
Malaysia’s MDA : Guidance on Classification of Rehabilitation, Physiotherapy & Speech Therapy Device
Malaysia’s Ministry of Health Medical Device Authority (MDA) division recently updated its "Guidelines on Classification of...
Sharan Murugan
Mar 14, 20231 min read
39 views
0 comments
Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System
Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...
Sharan Murugan
Mar 11, 20231 min read
150 views
1 comment
Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device
Malaysia’s Ministrt of Healths Medical Device Authority (MDA) division recently prepared a guideline "Guidelines for implementation of...
Sharan Murugan
Jan 19, 20231 min read
41 views
0 comments
Malaysia’s MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD
Recently on 21st November, 2022 the Malaysian Medical Device Authority (MDA) updated its guidelines regarding the "Requirement for...
Sharan Murugan
Nov 27, 20221 min read
17 views
0 comments
Malaysia’s MDA: HARMONISED CLASSIFICATION OFMEDICAL DEVICES IN ASEAN
Association of Southeast Asian Nations, or ASEAN, is a political and economic union of 10 members states in Southeast Asia, which are...
Sharan Murugan
Sep 7, 20221 min read
21 views
0 comments
MALAYSIAN (NPRA): VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has updated its variation guideline for pharmaceutical products to be in...
Sharan Murugan
Jul 27, 20222 min read
309 views
0 comments
Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT
Malaysia’s Medical Device Authority (MDA) & Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated guidance updates...
Sharan Murugan
Jun 16, 20221 min read
18 views
0 comments
Guidance on Classification of Rehabilitation Medical Devices -Malaysia’s MDA
Malaysia's Medical Device Authority (MDA) has drafted a guidance that will assist manufacturers and authorized representatives to...
Sharan Murugan
May 2, 20221 min read
17 views
0 comments
Malaysia’s MDA- Draft Medical Device Labeling Guidance
The Medical Device Authority (MDA) of Malaysia is seeking feedback on draft regulations for medical device labeling. The MDA's fifth...
Sharan Murugan
Apr 24, 20221 min read
9 views
0 comments