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Regulatory Updates

the thailand fda has terminated its pre submission system as of march 15, 2022

The Thailand FDA has terminated its pre-submission system as of March 15, 2022

March 18, 2022

draft fda circular for comments amending fda circular 2021 002 a

Draft FDA Circular for comments amending FDA Circular 2021-002-A

March 18, 2022

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Malaysia MDA draft guidance classification rehabilitation physiotherapy speech therapy devices

Malaysia MDA releases draft guidance on the classification of rehabilitation, physiotherapy and speech therapy devices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Malaysia MDA draft guidance medical device grouping

Malaysia MDA releases draft guidance on medical device grouping classification rules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

Indonesia launches dedicated ecatalogue medical devices

Indonesia’s Ministry of Health launches dedicated e-Catalogue for medical devices

February 15, 2022

Philippines Price Limit Covid19 RT PCR Tests

Philippines: Price Limit for Covid-19 RT-PCR Testing

February 14, 2022

Philippines FDA: List of registrable IVDs - guidelines for comments

Philippines FDA: List of registrable IVDs – draft guidelines for comments

February 9, 2022

Indonesia introduces simplified registration for certain class A medical devices

Indonesia introduces simplified registration for some class A medical devices

February 8, 2022

malaysia mda launches medcast 2 plus

Malaysia MDA launches MeDC@St 2.0+

February 8, 2022

philippines fda guidelines distribution and use of covid19 self test kits

Philippines DOH issues guidelines on distribution and use of Covid-19 Antigen Self-Test Kits

February 3, 2022

HSA update guidance on medical device product registration GN-15

HSA issues updated guidance on Medical Device Product Registration (GN-15)

January 31, 2022

HSA issues updated guidance on Grouping of Medical Devices for Registration

HSA issues updated guidance on Grouping of Medical Devices for Registration

January 31, 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

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