Public Consultation for Guideline on Importation, Consignment Verification and Lot release of Medical Product 2026.

Regulatory news and announcements|

The Medical product division under Bhutan food and Drug Authority is pleased to share the final draft... Read More Public Consultation for Guideline on Importation, Consignment Verification and Lot release of Medical Product 2026.

Competency Examination on 06 July

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... Read More Competency Examination on 06 July

Public Consultation on revised Guideline for Registration of Medical Devices.

Regulatory news and announcements|

The BFDA is sharing the guideline for your comments. This will be consulted for a period of two months from... Read More Public Consultation on revised Guideline for Registration of Medical Devices.

Public Consultation on Draft Guideline for Good Storage and distribution Practices.

Regulatory news and notifications|

The Medical Product Division of the Bhutan Food and Drug Authority (BFDA) is pleased to share the draft... Read More Public Consultation on Draft Guideline for Good Storage and distribution Practices.

Competency Examination on 05 May, 2026

Regulatory news and announcements|

This is to inform you that we will conduct the Competency Examination on 05 May, 2026 from 09:30 AM at the... Read More Competency Examination on 05 May, 2026

Notification-Revised Market Authorization Guidelines.

Regulatory news and notifications|

... Read More Notification-Revised Market Authorization Guidelines.

Regulatory Notification on Publication of Irrational FDC

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... Read More Regulatory Notification on Publication of Irrational FDC

Regulatory Notification on publication of Bioequivalence and Biowaiver list

Regulatory news and notifications|

... Read More Regulatory Notification on publication of Bioequivalence and Biowaiver list

Public Consultation on “Guideline for Post-market and market surveillance of medical device:Management of adverse events” 

Regulatory news and announcements|

The Medical Products Division of the Bhutan Food and Drug Authority (BFDA) is pleased to present the draft... Read More Public Consultation on “Guideline for Post-market and market surveillance of medical device:Management of adverse events” 

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