MedExel’s Pen Needles Obtain CFDA Certification in China
MedExel Co., Ltd. (CEO: Cha Dong-ik), a leading developer and manufacturer of pen needles, has successfully obtained certification from the China Food and Drug Administration (CFDA), following approvals from the U.S. FDA and European CE.
The CFDA certification is a mandatory approval for selling medical devices in China, known for its lengthy and stringent process.
MedExel was established in 2000 as a joint venture between American, German, and Korean companies to ensure a stable global supply of diabetes syringes and insulin pen needles.
With the addition of CEO Cha Dong-ik and Sales Director Shin Ja-ui earlier this year, the company has intensified its efforts to expand globally, and this certification marks a significant milestone in entering the Chinese market.
According to the company, they have already secured an OEM contract worth approximately USD 400,000 for delivery next year, following the first exports to China at the end of this year.
This is a successful example of a Korean medical device company’s stable entry into the Chinese market. MedExel plans to continue expanding its orders for OEM products from competitive companies in the Chinese medical device market. CEO Cha Dong-ik commented, “This certification has provided us with a foothold to enter the rapidly growing Chinese market. We will continue to aggressively target the Chinese market through ongoing R&D and the launch of new products.”
MedExel is a global company specializing in pen needles for self-injection pens, with 98% of its production exported to Europe and North America.
With over 15 years of experience in producing insulin syringes and pen needles, MedExel has established stable production facilities and accumulated technological expertise, earning long-term partnerships with numerous domestic and international clients.
With over 15 years of experience in producing insulin syringes and pen needles, MedExel has established stable production facilities and accumulated technological expertise, earning long-term partnerships with numerous domestic and international clients.
