The healthcare industry is drastically changing with the advancements in digital technology. With the virtue of this technological progress, the global medical device industry is now exploring new areas like wireless medical devices to improve care while lowering treatment costs. Manufacturers of such wireless devices have to follow a dual line of regulations (approval required from telecommunication authority and Regulatory Authority), and many countries have specific requirements concerning the medical device wireless technology licensing.

The Thailand Food and Drug Administration (TFDA) has issued certain rules for Thailand's foreign and local manufacturers who wish to sell medical devices involving wireless technology. For the importation of wireless technology devices with cellular, Radio Frequency Identification Devices (RFID), WiFi, or Bluetooth connectivity into Thailand, manufacturers have to get approval from the National Broadcasting and Telecommunications Commission (NBTC). The NBTC is the telecommunications commission of Thailand which requires all the wireless medical devices to obtain the approval certificate, an important customs clearance document. Manufacturers must note that even if NBTC provides the approval certificate for the device, the TFDA holds the ultimate authority to decide on whether to sell the device in Thailand.

NBTC classifies telecommunication devices into three categories-

Class A devices: These devices must be tested only in the NBTC accredited laboratories. Manufacturers must provide all the data required for approval and must also note that samples must be provided along with the application for some products. On approval of the application, the device will receive the login number and certification.

Class B devices: The same applicable products as Class A, and can accept foreign reports such as Radio Equipment Directive, FCC, Electro Magnetic Compatibility (EMC), application by using Conformity Assessment Body.

Supplier Declaration of Conformity (SDoC) compliance statement mode: The product requirements are voluntary. A local representative in Thailand makes an application. An SDoC form is required. Technical documents can be sent to the NBTC for inspection; samples are not required.

Obtaining NBTC Certificate:

The wireless medical devices falling under Class A and Class B require an NBTC Certificate for customs clearance. The manufacturers must ensure that the NBTC certificate is in place before the device is imported into Thailand. The foreign manufacturers must appoint a local representative with a commercial license issued by the NBTC for submitting the applications, customs clearance facilitation to the NBTC on behalf of the manufacturer.

The manufacturers can start their certification by identifying an NBTC accredited testing laboratory. Usually, the testing laboratories require the manufacturer to fill their standard test application (request) forms, submit product manuals and instruction manuals along with the device samples. The manufacturer is also required to share the list of testing standards (in a bottom-up test). The testing laboratories issue stamped reports for the devices that clear all the testing requirements.

The manufacturers must submit the application for NBTC certification along with the technical product documentation and test reports issued by the NBTC accredited laboratories. The technical product shall include product instructions, adapter safety report, list of key components, key component certificates, and certificate numbers for key component model manufacturers. The submission package shall include the product label, packaging picture, user instructions, and temperature requirements. The application should accompany 1-2 pieces of device prototype as well.

The NBTC requires 30 to 45 working days to review the application. The import license will be valid for 180 days from the authorization date and can be multiple times within the validity period. The NBTC application review fees vary with the device class as detailed in the below table -

This medical device wireless technology licensing in Thailand is a slightly lengthy but effective way to ensure that the medical devices imported and sold in Thailand are of good quality and do not pertain to any risk to the end-users. This seamless collaboration between the NBTC and the TFDA helps manufacturers place their wireless medical devices in a hassle-free way into the Thailand market.   

To know more about wireless technology licensing of medical devices in Thailand, reach out to a Regulatory expert like Freyr. Stay informed. Stay compliant.