Unlicensed Medical Device Overseas Direct Purchase Used by Dentists Caught Red-Handed

A large number of dentists were caught using low-cost (non-certified) dental medical devices imported directly from China for patient treatment, citing cost reduction as the reason.

The Seoul Regional Customs Office of the Korea Customs Service announced on the 6th that it had apprehended 13 dentists on charges of violating the Customs Act and smuggling.

Dental medical devices purchased from the Chinese e-commerce platform AliExpress and used for patient treatment, seized products. Provided by Seoul Regional Customs Office, Korea Customs Service

According to Seoul Customs, between December 2022 and April this year, these individuals are suspected of smuggling a total of 11,349 dental medical devices (worth approximately 140 million KRW) into the country through 1,184 transactions on the Chinese e-commerce platform AliExpress. It was revealed that the medical devices purchased through overseas direct purchase were actually used in patient treatment.

When importing medical devices from abroad, even if the value is under $150, approval from the Ministry of Food and Drug Safety for medical device import is required, and the devices must go through formal import customs clearance procedures rather than simplified clearance. However, in some cases such as self-treatment, medical devices can be imported through simplified clearance.

Simplified clearance is a type of streamlined system that allows individuals or companies to import goods valued at $150 (or $200 in the United States) or less, which are not subject to customs officer inspection, by submitting minimal product and transaction information to customs without a formal import declaration. Most goods imported through overseas direct purchase undergo this simplified clearance process.

The dentists caught were found to have abused this simplified clearance system to import non-certified medical devices into Korea.

They disguised the devices as items for personal use and imported various medical devices such as dental drills used for cavity treatment and tooth cutting, and oral anesthesia syringes that come into direct contact with patients' gums. In this process, they were exempted from import requirements and customs duties.

Seoul Customs believes these dentists smuggled non-certified medical devices by abusing the simplified clearance system for cost-saving purposes.

In particular, during the investigation, it was confirmed that they shared information about overseas direct purchase of medical devices through group chat rooms.

A Seoul Customs official stated, “To protect public health, we will strengthen customs clearance management for overseas direct purchases to prevent the import of non-certified and unauthorized medical devices. We urge the public to actively report illegal and fraudulent imports through e-commerce and related profit-making activities to the Customs Service Smuggling Report Center.”