It has been confirmed that disposable medical syringes are being sold without registration on the stationery and toy street in Changsin-dong, Jongno District, Seoul, which is famous for tactile toys such as malrang-i and wakppubol (wax smashing ball).
At toy stores mainly frequented by children and teenagers, medical devices with sharp metal needles can be purchased without particular restrictions, but inspections by authorities take place only after a tip or complaint is received, drawing criticism that this is a blind spot in safety management.
According to ChosunBiz reporting compiled on the 15th, a large stationery store on the Changsin-dong stationery and toy street was selling disposable medical syringes under the name "malrang-i syringe" for 1,000 won each. Inside the store, individually packaged syringes were displayed alongside various toys such as malrang-i and keycaps.
The thickness of the metal needle attached to the syringe was about 0.6 mm. Unlike blunt-ended injectors used in learning materials or toys, it was thin and sharp. The product packaging also indicated that it was a disposable medical device.
It appears that demand has arisen as a recent trend of inserting a syringe needle into malrang-i to release the internal air or inject contents to change the texture has spread. On social media such as YouTube and TikTok, many videos introduce how to use a syringe to make malrang-i softer.
The issue is that syringes are considered medical devices, so to sell them, a seller must file a medical device sales business registration with the local government with jurisdiction. Article 17 of the Medical Devices Act requires a business operator intending to engage in the sale of medical devices as a business to file a sales business notification with the mayor, county head, or district head with jurisdiction over the place of business. Violations can result in imprisonment for up to three years or a fine of up to 30 million won.
However, it was confirmed that the toy store in question had not filed a medical device sales business registration. In effect, it sold medical syringes without registration.
Not all products sold online or at variety stores under the name "malrang-i syringe" are medical devices. On the same day, more than 600 related items were found on Naver Shopping, but a significant number were not disposable syringes approved or certified for medical use; they were toy components for inflating or deflating air or liquid in malrang-i. Toy components that are not medical devices can be sold without a medical device sales business registration.
Online sales of medical syringes themselves are not illegal either. Companies that have completed a medical device sales business registration can sell medical syringes both online and offline. The current Medical Devices Act has no provisions restricting the buyer's age, so minors can purchase medical syringes through a lawful seller.
As a result, some say additional safeguards are needed in the current distribution structure that allows children and teenagers to easily purchase medical syringes. In particular, if medical syringes are displayed together with toys at toy stores, children might mistake them for ordinary toy components.
This is not the first time that the inclusion of medical syringes in children's toys has sparked controversy. Last year, a so-called "pimple popping" toy, in which foreign matter is inserted into a soft-textured doll and then squeezed out by hand, was sold with a medical syringe and metal needle included, prompting criticism that it threatened children's safety.
A Jongno District public health center official said, "We conduct regular on-site inspections for companies registered to sell medical devices," and added, "For toy stores, we crack down when tips or complaints arise."