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Malaysia–China Medical Device Regulatory Reliance Programme: Pilot Phase I (30 July – 30 September 2025)
The Medical Device Authority (MDA) of Malaysia has officially launched the Malaysia–China Medical Device Regulatory Reliance Programme ,...

Sharan Murugan
Aug 132 min read
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Malaysia’s NPRA Guidance: Drug Registration Guidance, What’s Inside?
On 22nd July 2025, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released the Third Edition, Tenth Revision of the " Drug...

Sharan Murugan
Jul 232 min read
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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