Public Consultation on the “ Narcotic Drugs, Psychotropic Substances and Substance Abuse Rules and Regulations 2026”

Regulatory news and announcements|

The Controlled Substance and Medical Device Division under the Bhutan Food and Drug Authority is pleased to... Read More Public Consultation on the “ Narcotic Drugs, Psychotropic Substances and Substance Abuse Rules and Regulations 2026”

Public Consultation on “ Standard for Designated Smoking Area 2026.”

Regulatory news and announcements|

The Controlled Substance and Medical Device Division under the Bhutan Food and Drug Authority is pleased to... Read More Public Consultation on “ Standard for Designated Smoking Area 2026.”

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

Regulatory news and announcements|

... 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.

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

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” 

Public Consultation on “Guideline for WHO-Collaborative Registration Procedure for IVDs 2025”

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 WHO-Collaborative Registration Procedure for IVDs 2025”

Competency Examination on 05 March, 2026

Regulatory news and announcements|

This is to inform that we will be conducting Competency Examination on 05 March, 2026 from 09:30 am at the... Read More Competency Examination on 05 March, 2026

Press Release on Launch of Drug Regulatory Information Management System (Drug-RIMS), and the Procedural Manual for the Operation of Sanitary and Phytosanitary (SPS) National Enquiry Point (NEP)

Regulatory news and announcements|

The Bhutan Food and Drug Authority (BFDA) is pleased to announce the official launch of the Drug Regulatory... Read More Press Release on Launch of Drug Regulatory Information Management System (Drug-RIMS), and the Procedural Manual for the Operation of Sanitary and Phytosanitary (SPS) National Enquiry Point (NEP)

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