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Malaysia

Malaysia guidance registration refurbished medical devices

Malaysia releases new guidance on registration of refurbished medical devices

February 24, 2022

Malaysia MDA draft guidance classification rehabilitation physiotherapy speech therapy devices

Malaysia MDA releases draft guidance on the classification of rehabilitation, physiotherapy and speech therapy devices

February 22, 2022

Malaysia MDA draft guidance medical device grouping

Malaysia MDA releases draft guidance on medical device grouping classification rules

February 21, 2022

malaysia mda launches medcast 2 plus

Malaysia MDA launches MeDC@St 2.0+

February 8, 2022

MDA Guideline on Registration of COVID-19 Test Kits

MDA Guideline on Registration of COVID-19 Test Kits

January 31, 2022

mda announces end special access routes covid19 test kits

Malaysian MDA announces end of Special Access Route for COVID-19 Test Kits

January 28, 2022

Restrictions online selling optical devices and contact lenses in Malaysia

Restrictions for the selling of Optical Devices and Contact Lenses online in Malaysia

January 17, 2022

Malaysia requirements for supplying Covid-19 self test kits

Requirements For Supplying Covid-19 Rapid Self-Test Kits In Malaysia

November 23, 2021

Malaysia conditional permission COVD19 self-test kits

Conditional permission for the import & distribution of Covid-19 self-test kits into Malaysia

November 2, 2021

New post marketing surveillance combined products Malaysia

New Post Marketing Surveillance procedures for Combination Products in Malaysia

November 2, 2021

Malaysia Authorized Representative

Malaysia MDA allows multiple authorized representatives for medical devices

September 30, 2021

Medical device advertising approval Malaysia

Medical device advertising regulations in Malaysia

May 25, 2021

Malaysia Code of Advertisement Medical Device Regulations 2019

Malaysia: Code of Advertisement Medical Device Regulations

May 8, 2021

in vitro diagnostic medical device

In-vitro diagnostic medical device product grouping in Malaysia

April 28, 2021

Medical device advertising approval Malaysia

Medical device advertising approval in Malaysia

April 20, 2021

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