The Medical Products Division of the Bhutan Food and Drug Authority (BFDA) is pleased to present the draft Guideline for Combination Product for your review and feedback.
This guidance document is designed to provide technical assistance to medical product suppliers regarding the regulatory requirement for registration of Combination Products (Device+Drug or Drug+Device).
We kindly request that you submit your comments, suggestions, or recommendations to help enhance the guideline. Please send your feedback to kptshomo@bfda.gov.bt by April 30, 2025.
Thank you for your valuable input and cooperation.