Regulation of medical masks (surgical mask and surgical respirator) for containing the spread of airborne diseases.
In exercise of power conferred by section 5 of The Medicines Act of the Kingdom of Bhutan 2003 and as per the recommendation from the Ministry of Health and National Covid-19 Task Force, the Drug Regulatory Authority (DRA) is pleased to share the “Interim Guidelines for Regulating Face Masks (medical grade), 2021 ” for immediate compliance by the stakeholders. Considering that non-medical masks are not construed as medicinal product/medical devices, DRA can only limit its scope to surgical masks and surgical respirators.
Accordingly, the potential importers and manufacturers of medical masks are hereby notified to acquire Authorization from DRA prior to sale and distribution in the country. The guidelines can be accessed from here Interim Guidelines for regulating Face mask (medical grade), 2021.
For further information and clarification, contact the Registration Division, Drug Regulatory
Authority at +975-2-337074/337075.
May 29th, 2023
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