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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 Medical Device Authority (MDA) Guidance: Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities
The Medical Device Authority (MDA)Â in Malaysia has released a comprehensive guidance " Control of Obsolete and Discontinued Medical...
Sharan Murugan
Nov 20, 20242 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 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: 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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Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT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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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
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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
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Draft Guidleline on Change Notification For Registered Medical Device-Malaysia’s MDA
This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their...
Sharan Murugan
Apr 17, 20221 min read
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Malaysia Draft Medical Device Guidance on PERSONAL PROTECTIVE EQUIPMENT (PPE) - REQUIREMENTS
The Malaysian Medical Device Authority (MDA) drafted a guideline on personal protective equipment (PPE) and seeks feedback from the...
Sharan Murugan
Mar 24, 20221 min read
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