License per Invoice (LPI) is an acknowledgment document required for importing medical devices into Thailand. LPI is a means used for prior verification of whether an active device registration exists for the products being imported into the Thai province. The importers must submit the LPI for hassle-free customs clearance. The License Per Invoice (LPI) is not a one-time activity but is required for every shipment for registered medical devices.
Why is an LPI Required?
An LPI eases the process and the time taken for customs clearance. All the details related to the consignment, including import license validity, restrictions on quantity, etc., are verified in advance. The LPI also guides the FDA inspector on the need for visual inspection of the consignment.
When Should You Submit an LPI?
The importers can submit an LPI two (2)-three (3) days before the consignment is expected to reach Thailand.
What is the Process for Obtaining an LPI?
The importer should submit the application and the necessary details and documents electronically through the National Single Window (NSW). The application shall include:
- Air Waybill (AWB)
- Packing List
- Bill of Lading (B/L)
- Shipping Invoice
- Import license Number
- Taxpayer Identification Number
- Branch Number
- Invoice Number and Invoice Date
- Imported Date
- Item Number in Invoice
- Quantity by Item and Units of Item
- Harmonized System (HS) Code
- Lot Number or Batch Number
- Manufacturing and Expiry Date
- Pack Size and Unit of Pack Size
- Quantity by Lot Number
- Net Weight of the Consignment
What Happens After the Application is Submitted?
Once the application is submitted to the NSW e-licensing portal, the Health Products Automated Licensing system for License Per Invoice (HAL.LPI) robot, as the back-end supporter, verifies the information related to the imported devices from the Thai FDA. It verifies and validates the status of device approvals, available importation quota for certain restricted approved products. The HAL.LPI also assesses the risk associated with each consignment ad determines the need for visual inspection by the customs agent. The HAL.LPI also transfers the details to the customs department.
What Would the Outcome of LPI Mean to the Consignment?
The consignment with the green label can be released without any inspection, whereas the red label must undergo inspection. In the case of a consignment with multiple products, even a single red label against one product would call for the inspection.
What is the Time Taken by the Thai FDA to Review the Application?
The entire process for reviewing the application takes one (1) to two (2) days by the Thai FDA. LPI is released immediately after completing the review process of the application.
Though the process for obtaining the medical device License Per Invoice (LPI) sounds forthright and straightforward, the device manufacturers find it difficult navigating through the NSW portal, which is in the Thai language. Hence, device manufacturers rely on their Thai Agents for the entire process of customs clearance. Since the local Thai Agent plays a significant role in the device registration and the import and customs clearance of every consignment, device manufacturers must meticulously choose their local representative.
For more information on License per Invoice for importing medical devices in Thailand and Thailand medical device regulations, kindly reach out to a proven Regulatory expert like Freyr.
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