Announcements & Notifications
Regulatory Notification on requirement of Import Authorization for prioritized list of medical devices
February 5th, 2024Please click here to view the notification
» read moreRegulatory Notification On Revised Document Requirement For Medical Devices Registration
January 25th, 2024Please click here to view the notification
» read moreRegulatory notification on regulation of Drug of Abuse test kits
March 8th, 2023Please click here to view the notification
» read moreNotification on rescheduling of clients visiting time for efficient service delivery
February 7th, 2023Please click here to view the notification
» read moreRegulatory Notification on Substandard (contaminated) paediatric medicines identified in WHO region of Africa.
October 6th, 2022Please click here to view the notification Product List
» read moreNotification on Requirement of Technical Authorization for sales, distribution of Medical Devices and Registration of Medical Devices
August 31st, 2022“The medicines Act of the Kingdom of Bhutan 2003”, mandated the Drug Regulatory Authority to develop policies, guidelines and standards on the regulation of medicinal products including medical devices to ensure the safety, quality and efficacy/performance of these products in the market. Furthermore, pursuant to the provisions of the same law, a Technical Authorization is […]
» read moreRegulatory Notification for Mandatory Submission of e-dossiers and Sample Submission
April 14th, 2022Click here to view the notification
» read moreRegulatory Notification on Requirement of Emergency Use Authorization (EUA) for Import, Sale and Distribution of COVID-19 self-test kits
April 6th, 2022Please click here to view the notification
» read moreRegulatory Notification on Sale, distribution and use of COVID-19 antigen self-test Kits
March 30th, 2022Please click here to view the Notification
» read moreRegulatory Notification: List of Manufacturers Eligible for Product Registration via Company recognition.
December 9th, 2021Please click here to view the notification
» read more