“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 required for establishments engaged in the sale, distribution and manufacturing of any medical device including in-vitro diagnostic device henceforth. Medical devices requiring Technical Authorization from DRA for sales and distribution incorporates the list of the medical devices published by the DRA (The Medical Device list would be updated and notified from time to time). Additionally the products listed must also be registered by the wholesalers prior to obtaining Import Authorization from the DRA. Authorizing the medical device suppliers, manufacturers and retailers and registering the products will ensure access to safe, quality and effective medical devices. The Guidelines for registration and Import Authorization has been uploaded on the DRA website (www.dra.gov.bt) for access.
Therefore, all the concerned individuals are requested to comply with this regulatory notification and visit the DRA office for registration of your firm and medical devices and clear the stocks (unregistered medical devices) within 6 months of this notification as per section 16.2.3 of The Medicines Act of The Kingdom of Bhutan, 2003.
This notification is issued for immediate compliance.
For any further clarification & queries kindly contact DRA officials at +975-2-337074/337075
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