As of July 17, 2017, we have confirmed that we submitted pre-submission documents for pre-screening for US FDA certification.

In order to receive US FDA certification, which will gain synergies to advance into the US market and global marketing, we submitted the technical documentation and Usability test result for the new product, Anyfusion.

When the usability test is completed and the FDA preliminary review is performed, the usability test is carried out in accordance with the protocol method. If the improvement is found, the upgrade is carried out and the final test takes place in orderly.

If technical document and usability test protocol go through the preliminary review, make improvements if needed, and apply for the certification examination, it is possible to save time and cost by solving the recurring supplementary problems that may occur by conducting the examination, thus all process is proceeded with consultation with domestic and US consulting companies with expecting the approval in the first half of 2018.

Although Pre-submission review period is about 90 days, with the effort to optimize it, we are expecting the completion within a short, positive period.

We would like to express our gratitude to the companies and stakeholders for their support in preparation with hope of good results.