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Malaysia

Monkeypox IVD test

Malaysia: Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA

September 29, 2022

New compliance rules

Malaysia: MDA Released Two New Guidance Documents on Harmonized Risk Classification of Medical Devices and Borderline Products in ASEAN

September 12, 2022

C*VID-19 medical grade face masks

Malaysia: Enforcement Activities Carried Out By The MDA During The Participation In The Pangea XV 2022 Operation

August 24, 2022

Nurse operating medical device

Malaysia: MDA launches MEDICAL DEVICE CENTRALIZED REPORTING SYSTEM (MEDCREST)

July 18, 2022

Medical device paperwork

Malaysia: Full Enforcement Announcement of Medical Device Regulations (Responsibility & Establishment) 2019

July 11, 2022

Team labelling medical devices

Malaysia: Medical Device Authority Releases Fifth Edition of Requirements for Labelling of Medical Devices

July 11, 2022

Medical labelling

Malaysia: MDA Provides Transition Period For Compliance With The Requirements Of Labelling Of The Medical Devices (MDA/GD/0026, Fifth Edition)

July 6, 2022

obsolete medical equipment

Malaysia: Medical Device Authority (MDA) Amends Policy for Control over Orphaned, Obsolete and Discontinued Medical Devices

June 23, 2022

medical device

Malaysia: Medical Device Authority (MDA) Improves the Policy for Control of Medical Device Refurbishment

June 21, 2022

covid19 test kit

Malaysia: MDA Announced Exemption of Conformity Assessment Process for the Registration of Covid-19 Test Kit

June 21, 2022

license registration

Malaysia: Enforcement Announcement by Malaysian Medical Device Authority (MDA) Following an Investigation into the Use of Unregistered Medical Devices

June 21, 2022

Patient having blood test with vacutainer bottles in front

Malaysia: First Edition Guideline Document MDA/Gl/08: Re-Registration Of Registered Medical Device

June 7, 2022

Two scientists wearing PPE

Malaysia: Medical Device Authority Releases Second Edition of Medical Device Guidance for PPEs

June 1, 2022

Learn about the updates to dental laboratory regulatory requirements, as announced by Health Sciences Authority (HSA) Singapore on 10th May 2021.

malaysia mda releases second edition of guidance on the rules of classification for general medical devices

MALAYSIA MDA Releases Second Edition Of Guidance On The Rules Of Classification For General Medical Devices

May 23, 2022

conformity assessment procedures for medical devices approved by recognized countries

Conformity Assessment Procedures for Medical Devices Approved by Recognized Countries

May 1, 2022

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Regulatory Services

Registration
Local Authorized Representative
Post Market Surveillance
Regulatory Intelligence Reports
Regulatory Training

Market Access Services

Importation
Distribution

Target Markets

Indonesia
Malaysia
Philippines
Singapore
Thailand
Vietnam

Insights

Regulatory Updates
Market Access Updates
Events & Other News

About us

Why Choose Us
Meet The Team

Contact Us

[email protected]
+60 4566 0200

Linkedin Twitter Facebook

Copyright 2023 © Andaman Medical | Privacy Policy
Web Design by Brilliant Digital

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