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Wireless Medical Device Registration in Thailand
Wireless medical devices are imported or manufactured in Thailand and incorporate wireless technology, such as cellular, RFID, WiFi, or Bluetooth, are subject to regulatory requirements of the National Broadcasting and Telecommunications Commission (NBTC). Each product must obtain an Approval Certificate which is a required element of Customs clearance documentation.
Required Documentation for Wireless Registrations
Required documentation including, but not limited to:
- NBTC form
- ID cards and License Holder Registrations
- Power of Attorney
- Tech specs and test reports
- Photos of equipment
Wireless Registration Notes:
- Original documents must be in Thai or English, or a translated version must be attached to the original.
- For Class B and Class A, the NBTC staff ้request to review product details in advance.
- You can find a complete list of NBTC Standards here.
Thai NBTC Fees and Processing Times
|Device Type||Technology Covered||NBTC Fee||NBTC Processing Time|
|Class A||RFID, WLAN, WPAN||ThB 1,000**||5 working days|
|Class B||Cellular||ThB 5,000**||10 working days|
|SDoC*||Bluetooth, WIFI||none||2 working days|
*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.
Thailand Regulatory Support
US: +1 512 898-9222
Latest Market Updates
- TFDA Implements New Annual Reporting Requirements in ThailandApril 8, 2022 - 2:07 pm
- TFDA Updates Review Timelines for Medical Device ApplicationsApril 8, 2022 - 11:13 am
- Thai FDA Streamlines Medical Device Registration ProcessMarch 16, 2022 - 1:07 pm
- Thai FDA Updates List of Chemical PollutantsMarch 15, 2022 - 1:38 pm
- Thailand Fast Tracks Class D Medical Device Registration with Singapore Approval StatusOctober 25, 2021 - 9:47 am