Is it necessary for the company name, which has received import permission under the Medical Device Act, to match the 'importer' information on the customs import declaration for proper customs clearance when importing medical devices? Released

Regarding the import of medical devices, we provide a clear answer to the question of whether the company name that has received import approval under the Medical Device Act and the 'importer' information on the customs import declaration must match. To conclude, yes, the two pieces of information must match for normal customs clearance to be possible.

This is based on an important amendment to the medical device regulations, which has been in effect since April 9, 2012. The core of this amendment is to allow imports only in the name of those who have received import approval under the Medical Device Act, considering the specificity of medical devices and their impact on public health. Therefore, the 'importer' field in the import declaration submitted to customs must be filled with the name of the person who has received import approval under the Medical Device Act, that is, the person who has received import approval according to the standard customs clearance report.

Background and Importance of the Obligation to Match Medical Device Importers

Since medical devices are used directly on the human body or for the purpose of diagnosing, treating, alleviating, or preventing diseases, their safety and effectiveness are very important. Due to these characteristics, the regulations on import procedures are much stricter than for general goods, and thorough pre-examinations are conducted through the import approval system under the Medical Device Act.

The importer under the Medical Device Act is not merely the subject performing the import act but is the legal entity responsible for the overall domestic distribution and post-management of the medical device. They must meet the standards set by the Ministry of Food and Drug Safety (MFDS) in terms of medical device quality management systems, facilities, personnel, etc., and must fulfill legal obligations such as recall, disposal, and adverse event reporting when problems arise. Therefore, by matching the 'importer' in the customs import declaration with the importer, the aim is to clarify the responsibility from the customs clearance stage and fundamentally block the domestic inflow of unauthorized or illegal medical devices.

Role of the Standard Customs Clearance Report

The 'Standard Customs Clearance Report' is a very important document in the import of medical devices. It is a procedure where the MFDS (or a delegated agency) is submitted before import to pre-confirm whether the medical device can be imported according to domestic regulations. Customs clearance is only allowed if the name of the 'importer' in this report matches the 'importer' field in the customs import declaration. This serves as a key basis for customs to verify that the goods are medical devices being imported by a legitimate entity when receiving the import declaration.

Distinction between 'Importer' and 'Taxpayer'

To help you understand, we will also explain the relationship between the 'importer' and the 'taxpayer' on the customs import declaration.

• Importer (Consignee/Importer): The person who has received import approval under the Medical Device Act and becomes the domestic legal management entity of the medical device. This name must match the importer under the Medical Device Act.
• Taxpayer: The person who has the obligation to pay customs duties and domestic taxes. Generally, the 'importer' often becomes the 'taxpayer,' but it can vary depending on the case. For example, if the importer acts on behalf of a specific client for import and the client bears the customs duties (e.g., reverse import under DDP terms or a specific form of purchase agency), the 'importer' is the importer, but the 'taxpayer' can be the client. As presented in the original answer, both '① the importer is the importer and the taxpayer is not the importer' and '② both the importer and the taxpayer are importers' are possible. The important point is that regardless of who the taxpayer is, the name of the 'importer' must be the same as the importer under the Medical Device Act.

Conclusion and Precautions

Therefore, if you wish to import medical devices, you must ensure that your company (the questioner's company) holds a valid import approval under the Medical Device Act and that your company name (importer name) is accurately entered in the 'importer' field of the customs import declaration. If this information does not match, customs will refuse clearance, leading to unnecessary costs and time waste such as return, disposal, and storage fees of the goods.

Compliance with regulations is most important when importing medical devices, so it is the best way for safe and prompt customs clearance to thoroughly review relevant laws and seek expert assistance.