In the existing KFDA product classification, there are no items that can be mixed and injected with pharmaceuticals.

In consultation with the Ministry of Food and Drug Safety, we obtained approval for the injection as a cylinder type medicine injection pump, “Anyfusion pump” and a cylinder type medicine injection pump “cartridge set”, and for the preparation, as an electric medicine mixing device and an electric medicine mixing line.

However, the officials of National Institute of Medical Device Safety Information, who are supervising the approval for class 2 medical devices, should use injection only for injection purposes, and preparation may only be used for preparation purposes. It was interpreted that it violated the medical device law.

After that, We applied for complaints to the Food and Drug Administration several times, made them visited, explained, understood, discussed, reviewed, and received the final reply today.

For the ACPi technology, which is an integrated preparation and injection, it is necessary to determine whether it is a medical device according to the "Medical Device Act" for the first time. We had received a reply from the Medical Device Policy Division of the Ministry of Food and Drug Safety that it is a combination medical device that combines the technology as the preparation and infusion.

The cylinder infusion pump and cartridge set became the first combined medical device to be formulated and injected as a medical device with a combination of technology.

We will complete the development of CAM this week, demonstrate and introduce it to medical institutions starting next week, for understanding the new technology of a closed system that has reduced the risk of contamination and infection for anticancer drug preparation that have been impregnable because there is no suitable technology so far.

Since our products can be easily used in existing BSC facilities without additional facility cost investment, we are confident that it will be an innovative medical device that improves the quality and difficult cleanroom preparation work.

Thank you for your hard work and cooperation from the Ministry of Food and Drug Safety (MFDS) and National Institute of Medical Device Safety Information (NIDS).