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India to Regulate Glucometers, Blood Pressure Monitors, Nebulizers and Digital Thermometers
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.
Indonesia Tightens Enforcement of Medical Device Licensing
With the implementation of Regulation No. 60, 2017 on February 1st, 2018 the Indonesia government tightened enforcement of medical device licensing requirements.
Philippines Proposes New Fees for Medical Device Registration
The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.
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India to Regulate More Medical Devices
At the May 16th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed that expands the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India. The following device categories are affected: