Notice

Anyfusion cylinder pump progress for Domestic & Overseas

1. Distributor selection: Last week, L company executives and L company's Americas officials introduced a video meeting, shared information on entering the Americas, used area ICU, ambulance, helicopter, highland, PCA, etc.
Consultation with distributors to reflect company expectations and requirements for five to six weeks (mid-to-end March), contract expectation, contract size, production schedule, inventory, transportation, A/S, insurance registration, etc. in April.
2. Meeting with investors: Completed 1st meeting with 3 companies, expected IR during January-February, requested foreign investors to invest.
3. Progress outside the U.S.: sales in Spain and Portugal, introduction of Spanish buyers, selection of partners in the U.S. market, consultant reports important progress next week, Saudi Arabia finalizes negotiations on February 1, 2023.
4. Domestic: Suggested equipment committee for code listing of Major Seoul U University A Hospital, Gyeonggi-do A University Hospital, Daegu K University D Hospital, first purchase expected around March.
5. Ministry of Food and Drug Safety, Ministry of Health and Welfare:
   1) In the case of being selected for Breakthroug or STeP as an innovative medical device by the US FDA, review of regulatory improvement included in the domestic innovative medical device integrated review and inclusion in the business plan, non-reimbursement or medical care benefit for 3 to 5 years if selected as an integrated review.
   2) It has been verified as a medical device with significantly improved safety and effectiveness and has been selected as FDA STeP. It is the duty of the state to prevent patients from being exposed to the risk of medical accidents at all times due to the use of existing medical devices with serious safety and effectiveness problems. The government, which has emphasized the use of selective benefits, neglects the state's obligations and responsibilities, and prompt conversion of medical care benefits is being requested and reviewed as a matter of course.
6. HIRA: FDA STeP selection factor, value for safety and effectiveness, price increase computerized submission.
7. Significant delays in drug and medical device certification due to FDA manpower shortage, purchase of PRV (Priority Review Vouchure) at a cost of $100 million to obtain expedited approval for drugs, STeP granted priority review.


Thank you.

Next Arab Health 2023 International Exhibition Participation (UAE) Result and Current Status
Prev New Year's address 2023