NaiVec Obtains First European CE Certification for Medical Device Based on Bioactive Biomaterial

[Asia Economy Reporter Hyunseok Yoo] Naivek, a peptide fusion technology specialist company, has become the only domestic company to successfully obtain European certification (CE) for bioactive biomaterial-based medical devices, thereby officially launching its biomaterial business.

Naivek announced on the 1st that it has successfully obtained European certification for two bioactive biomaterial-based medical device products, 'OCS-B' and 'OCS-B Collagen,' in Europe and Turkey.

The certification obtained this time corresponds to the medical device regulation (MDR) section of the European certification. The European Union recently introduced a strengthened MDR compared to the previous one. The number of notified bodies authorized to review and grant certification under MDR has decreased from about 80 to 48, making it more challenging to obtain certification.

A Naivek official said, “Naivek has become the first domestic company to successfully obtain MDR European certification in the bioactive material medical device sector, enabling full-scale entry into overseas markets. As the related market is rapidly growing worldwide, we expect sales growth in related business sectors to accelerate based on Naivek’s quality system and production processes that comply with international standards.”

He added, “This MDR European certification is the first of its kind in Korea, and through this, Naivek has externally verified its technological superiority, which will allow it to secure a leading position in overseas expansion.”

Naivek is expanding its global market share by supplying products through global distribution channels such as Straumann and Nobel Biocare. In particular, to enter the largest Asian market, China, it has been pursuing product approvals for dental bone graft materials and periodontal tissue regeneration products since 2014. The recently approved 'OCS-B' has completed the submission of related documents to the China Food and Drug Administration and is currently undergoing the final review process.

This content was produced with the assistance of AI translation services.