- How do I register medical devices in Bhutan?
Please follow the procedures given below:
a. Check the latest notified list of medical devices issued by DRA in the DRA website under the notifications section for the latest update. Current: Medical Device List
b. If your product requires registration with the DRA, register your firm as per the requirements set in the notification Notification on Medical Devices
c. Before Registration of your firm ensure that you have a registered competent person for both wholesale and retail. The qualification for the competent person is also mentioned in the notification Notification on Medical Devices
d. Register medical devices as per the requirements set in the guidelines for Registration of Medical Devices, 2022 Guideline for Registration of Medical Devices, 2022.pdf
- Can I participate in a tender for government supplies?
Only registered medical devices (notified list of medical devices) are eligible for tendering.
- Who can register and distribute medical devices in Bhutan?
Answer: Only Authorized Technical Authorization Holder(wholesalers) can register and distribute medical devices in Bhutan. Manufacturers outside can route the registration of medical devices through registered firms( Firms registered with the DRA)
- What is the role of medical device retailers in Bhutan?
Answer: The retailers must also be registered with DRA and have a competent person like wholesalers. However they can only sell the medical devices to the consumers directly (with/without prescription as per the applicability) and are not allowed to distribute the products in bulk.
- Where should I contact for further information?
You can email or call us during office hours at the following:
E-Mail: registration@dra.gov.bt
+975-2-337075