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LATEST NEWS.

India’s CDSCO Extends List of Notified Devices

On December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.

Philippines FDA Announces New Requirement for All Medical Devices

On January 4th, the Philippines FDA released FDA Circular 2021-002. This Circular outlines new requirements for previously exempted medical devices, amending the previous transition plan. All remaining Class B, C, and D devices not listed in the updated Annex will now need to apply under the Notification route currently used for Class A devices.

Philippines FDA Alters Requirements for Radiation Licensing During COVID-19

FDA's Circular No. 2020-035 will take into effect immediately, and will pertain to the conduct of licensing inspection for radiation facilities in particular.