Binh Thai - Thailand

“The License Per Invoice issued by the Thai FDA is a unique step in the importation process for medical devices in Thailand”

Binh Thai
Asia Actual, Thailand

IMPORTING MEDICAL DEVICES INTO THAILAND

Tips for navigating a complex market

Published August 17, 2020

CUSTOMS CLEARANCE IN THAILAND

Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.

Unique to the customs clearance process for medical devices in Thailand is the requirement for a License Per Invoice (LPI) approved by the Thai FDA for each shipment. The Import License holder must apply with credentials, the original Import License, and original shipping documents (e.g., Air Waybill, shipping invoice and packing list) submitted online to Thai FDA. (The one-time fee to the TFDA for LPI submission which includes the Stamp Duty, Power of Attorney, and document submission). The FDA will confirm that all devices included in the shipment (by part number) are covered by a valid import license and then issue the LPI.  The application review process take 1 to 2 days.  The resulting License Per Invoice document is a required element of the customs clearance process for registered medical devices, accessories and spare parts.

THAILAND IMPORTATION DOCUMENTS & FEES

The overall process is then similar as in other countries with assemble a submission of shipping documents, payment of import tax (if any depending on HS code), payment of VAT (7% on all goods and services), etc.  Shipping rate will vary significantly by mode and point of origin; and should be known to manufacturers.  Customs Clearance charges should not exceed 1% of Cost of Goods.

OVERVIEW OF THE THAILAND IMPORTATION PROCESS

Thai Importation Process

COMMON DELAYS FOR FOREIGN IMPORTERS

  1. Discrepancies or inconsistency with HS Code (when using different freight forwarders)
  2. Inconsistency between shipments with the value of goods
  3. Delayed LPI application filing
  4. Shipments containing expired and valid items as Customs does not allow for partial clearance
  5. Shipments containing parts from different manufacturers

CONTACT ASIA ACTUAL TODAY

Using Asia Actual as your License Holder in Thailand comes with the added benefit of expertly managed, efficient and transparent importations.

Contact Asia Actual for more information on our importing services.

Blog Posts

Navigating the New Vietnamese Public Medical Device Pricing Portal

The new Medical Device Pricing Portal was opened to the public on November 20th with the goal of setting new international standards for medical device sales transparency. The medical device section is split into 2 sections, the Medical Equipment Price and Pricing Information on Winning Bids. On one side, users can view product listings and on the other, review all final government purchases, including contracted pricing.

China’s Green Pathway Registration for Innovative Medical Devices

China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.

Thailand Implements New Medical Device Regulations

On February 15th the Thai FDA published significant new guidance governing the classification, technical documentation requirements, fee schedule and transition plan for medical device registration. This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2) with the ASEAN Medical Devices Directive.