A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

PHILIPPINES TO HOST ASEAN MEDICAL DEVICE COMMITTEE MEETING / TRAINING

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The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019.

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India to Regulate Glucometers, Blood Pressure Monitors, Nebulizers and Digital Thermometers

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At the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.

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INDIA OFFICIALLY REQUIRES FIRST NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017

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Ablation Devices Now Require Registration in India

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The India Ministry of Health and Family Welfare added ablation devices to the list of notified medical device that require registration.

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The Philippines FDA Streamlines Amendment Submission Process

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On December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.

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