From 12 to 16 November, Alchimia hosted the Chinese regulatory authority (CFDA) for an inspection of its Quality Management System in reference to the products already registered or being registered in China, perfluorodecalin HPF10 and the ophthalmic gas GOT Multi C3F8, and in anticipation of the registration of other products of the ophthalmic line. The synergy between the Italian staff and the staff of the from our representative office in Beijing made it possible to easily overcome even the linguistic challenges of an inspection conducted in English and Chinese. The inspectors appreciated the robustness of the Alchimia’s Quality Management System, which also proved compliant with regulations other than those normally applied in Europe, and the competence and helpfulness of the personnel involved in the audit.
In turn, Alchimia appreciated the constructive spirit of the inspection that, due to its close and in-depth nature, allowed a useful comparison and represented a further opportunity for the growth of the company.
Alchimia is one of the leading European manufacturers of medical devices for ophthalmic surgery and human tissue banking with the aim of improving the daily routine of the medical personnel and the quality of life of patients.
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