(English name: SDM Co., Ltd), the State Drug Administration recently conducted on-site inspections of dental implant systems (English name: Implant system; registration certificate No.: GuoMeChiZhongJin20153171003) and expanded polytetrafluoroethylene facial implants (English name: e-PTFE Facial Implant; registration certificate No.: GuoMeChiZhongJin20193130136), and the State Pharmacopoeia Administration recently conducted on-site inspections of dental implant systems and expanded polytetrafluoroethylene facial implants. Implant; Registration Certificate No.: GuoMeZhiJin20193130136). Inspection found that Korea Sukwol Medical Co., Ltd. in the document management, design and development, production management, quality control and other aspects of the quality management system has serious deficiencies, the relevant products have quality and safety risks.

In order to protect the public safety, according to the “supervision and management of medical devices regulations” and “supervision and management of medical devices” relevant provisions, the State Drug Administration decided from now on, South Korea Sukwol Medical Co., Ltd. dental implant systems and expanded polytetrafluoroethylene facial implants, suspended the import, operation and use.

Hereby announced.

State Drug Administration

September 30, 2024