KFDA (Korean Food and Drug Administration) has approved Leapmed Healthcare Corporation as the qualified manufacturer to sell medical products in Korea.
This is another good news followed by CFDA, CE and FDA approval!
Today we will tell you the Story between Leapmed and Korean market.
Mr. L is the exclusive distributor of Leapmed in South Korea. He just finished his third visit to Leapmed within 2019. During each visit, Mr. L brought us with Korean doctors’ positive feedback, which makes Leap med’s team very excited. At 2017 CMEF (China International Medical Equipment Fair) exhibition, it was the first time Mr. L noticed Leapmed .For its professional booth and innovative products, he decided to have a try to do business with Leapmed after the constructed talk. He believes that the disposable biopsy kits developed by Leapmed has renewed his perception of the “Made in China” products, no matter from totally disposable concept or overall solution (“All in one” series) perspective. Therefore, Mr. L determined to cooperate with Leapmed to exploit Korean market!
At this moment, Leapmed’s disposable ultrasound interventional product has been sold to more than 30 countries, including U.S.A., Germany, France, Italy, Australia, Brazil, Korea ect. Once again, Leapmed demonstrates its Chinese interventional medical innovation and development to the world!
Exclusive interview with Korean partner:
What Leapmed initially attracts you most that motivates you to cooperate?
Mr. L: I have more than 20 years’ experience in the ultrasound intervention field in South Korea. In the past, I have distributed many products under relevant chains, such as B.Braun, Johnson & Johnson consumables, etc. About 10 years ago, I started to focus on distributing ultrasound interventional consumables since ultrasound interventional field was a very flourish market in South Korea. That is why I took part in CMEF. It was a very exciting moment to find the disposable biopsy guides / kit presented in Leapmed’s booth. In South Korea, I have been engaged in this area for many years, so I understand the market and potential of these products very well. Leapmed’s unique all-in-one design, which differentiate from American products as I know. It increases the efficiency of disposal and reduces the risk of cross-infection. At first sight, it made me think these goods were from some European brand due to good texture! So the reason for our cooperation is because of Leapmed’s excellent product quality! Awesome!
As we know, KFDA’s audit is extremely strict. Some experts from KFDA’s regulatory center came to China for an on-site audit for 4 days. Regarding this KFDA’s audit, how do you evaluate Leapmed team?
Mr. L: I must use two words to describe the excellent job, which are "professional" and "international". Firstly, Leapmed team is very professional, not only reflects in product design and development capabilities, but also in manufacturing, quality system control and business. As I said KFDA’s audit is very strict, a committee with top experts from Korean audit agency came on-site to audit Chinese facility, and the average age of the experts was over 50. In South Korea, it is common that manufacturers are rated as c-level (meaning not passed). At beginning, I had some concerns and doubts. After all, I invested a lot in the early submission stage. As a result of the excellent organization structure, operation, procedure documents, quality control, etc., we meet all of KFDA’s requirements and successfully passed the audit.
Secondly, the team is very international. KFDA’s audit was conducted in both English and Korean, but there is not much language barriers for team members. Audit documents were converted to English perfectly, which surprised me a lot. Not only their sales team, but also research and production teams have visited many countries. Hence, they have an international perspective. It helps very much with the experience they have accumulated in past CE and FDA audit. The team was able to express the difference between the KFDA with CE or FDA very well and leaves a very good impression for KFDA auditors.
The ability to meet quality requirements under different international audits proves a good understanding of the system requirements and the high standard of execution ability. Professionalism and internationalization is my confidence in the development of Leapmed business in Korea. I do believe competitive product and quality assurance is the foundation of long-term cooperation!
What is your expectation for business cooperation with Leapmed?
Mr. L: I have high expectation to develop Korean market with Leapmed. Their products have very competitive advantages.
Ultrasound intervention in South Korea also focuses on "precision" and "standardization", especially that infection control requirement is very strict, and the trend is getting stricter in South Korea. Metal guides are gradually replaced by disposable ones. Leapmed’s overall disposable concept is widely recognized by Korean experts. Quality of transducer cover as well as sterilized gel is very good and the price system is very competitive. It is one of the best products I have seen in last 2 years.
I am very confident about our future business growth! In the future, we hope that Korean experts would have more communication and cooperation with Chinese experts to set up academic exchanges platform for Sino-Korea ultrasound intervention, and carry out in-depth cooperation and product exploration through this platform. Thank Leapmed for the trust, and let us explore a better future together!
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