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Malaysia

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

malaysia mda releases public comment draft medical device guidance document on requirements for labelling medical devices

Malaysia MDA Releases Public Comment Draft Medical Device Guidance Document on Requirements For Labelling Medical Devices

April 25, 2022

malaysia mda releases public comment draft for change notification on registered medical devices

Malaysia MDA Releases Public Comment Draft For Change Notification on Registered Medical Devices

April 25, 2022

a reminder that medical devices must be registered and imported correctly

A Reminder That Medical Devices Must be Registered and Imported Correctly

April 25, 2022

medical device authority confirmed disinfectant body spray is not subject to the control of the medical devices act 2012 (act 737)

MALAYSIA MEDICAL DEVICE AUTHORITY CONFIRMED DISINFECTANT BODY SPRAY IS NOT SUBJECT TO THE CONTROL OF THE MEDICAL DEVICES ACT 2012 (ACT 737)

April 25, 2022

announcement on the requirements for covid 19 self test kits

MALAYSIA ANNOUNCEMENT ON THE REQUIREMENTS FOR COVID-19 SELF-TEST KITS

April 25, 2022

registration of covid 19 ivd test kits

REGISTRATION OF COVID-19 IVD TEST KITS IN MALAYSIA

April 25, 2022

new guidance was issued for rehabilitation, physiotherapy, and speech therapy devices

New Guidance Was Issued For Rehabilitation, Physiotherapy, And Speech Therapy Devices

April 22, 2022

mda is aware of buyer concerns about collecting and storing their personal information when purchasing self test covid 19 kits in malaysia

MDA is Aware of Buyer Concerns About Collecting and Storing Their Personal Information When Purchasing Self-Test Covid-19 Kits in Malaysia

March 31, 2022

medical device authority releases draft amendment or second edition of medical device guidance for ppes

Medical Device Authority releases draft amendment or second edition of Medical Device Guidance for PPEs

March 18, 2022

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