Wireless Medical Device Registration in Thailand

Required Documentation for Wireless Registrations

Required documentation including, but not limited to:

1. NBTC form
2. ID cards and License Holder Registrations
3. Power of Attorney
4. Tech specs and test reports
5. Photos of equipment

Wireless Registration Notes:

1. Original documents must be in Thai or English, or a translated version must be attached to the original.
2. For Class B and Class A, the NBTC staff ้request to review product details in advance.
3. You can find a complete list of NBTC Standards here.

Thai NBTC Fees and Processing Times

*Supplier Declaration of Conformity

**(Fees excluding 7% VAT)

Labeling Requirements for Medical Devices with Wireless Technology

The  registration process for Class A and B wireless devices will generate an NBTC Registration number, which must be included in the product labeling. This requirement does not apply to SDoC categorized devices.

Importing Medical Devices with Wireless Technology

Certain Class A  and Class B wireless devices require an Import license to clear Customs. The import license will be valid for 180 days from the date of authorization and can be multiple times within the validity period.  All other Class A and B devices and SDoC devices are Cleared through customs with a valid NBTC Approval Certificate. (NOTE: Medical devices are still subject to the Thai FDA requirements for importation.)

Grow With Us

Asia Actual has experienced professionals and is fully licensed (a copy of our NBTC Commercial License is available upon request.) that support medical device manufacturers utilizing wireless technology to ensure compliance with the NBTC standards and smooth Customs clearance.

Contact Asia Actual today with any questions or requests for support to register or import wireless medical devices.