Regulatory Reporting Requirements in Bhutan
Ensuring Public Safety and Health with Stringent Regulations
The Royal Government of Bhutan has established rigorous regulatory requirements for medical devices to safeguard public health. Medical device manufacturers, wholesalers, and retailers must adhere to these regulations to operate within the country.
Registration Requirements for Medical Devices
According to the Department of Regulation and Advertisement (DRA), medical device manufacturers and importers must follow a series of steps to register their products in Bhutan:
Step 1: Check the Notified List of Medical Devices
- Visit the DRA website for the latest update on notified medical devices.
Step 2: Register Your Firm as Per Requirements
- Ensure your firm meets the requirements set out in the Notification on Medical Devices.
- Register your firm with the DRA accordingly.
Step 3: Appoint a Competent Person
- For wholesale and retail sales, appoint a competent person who meets the qualifications mentioned in the same notification.
- This is a mandatory requirement for registration with the DRA.
Step 4: Register Your Medical Devices
- Once the above preconditions have been met, register your medical devices as per the Guidelines for Registration of Medical Devices, 2022.
Eligibility for Government Tenders
Only registered medical devices listed on the DRA website are eligible to participate in government tenders.
Authorized Technical Authorization Holders
- Wholesale companies that are authorized technical authorization holders can register and distribute medical devices in Bhutan.
- Manufacturers outside of Bhutan can route registration through approved firms by the DRA.
Registration Requirements for Retailers
Medical device retailers must be registered with the DRA and have a competent person appointed. However, they are only allowed to sell medical devices directly to consumers and cannot distribute products in bulk.
Contact Information
For further information on regulatory reporting requirements in Bhutan, contact the DRA at registration@dra.gov.bt or call them during office hours.