Haiyan Kangyuan Medical Instrument Co., Ltd. successfully obtained the EU medical Instruments regulations (EU 2017/745, referred to as “MDR”) certificate on February 1, 2023, the certificate number is 6122159CE01, and the scope of certification includes Endotracheal Tubes for Single Use, Sterile Suction Catheter for Single Use, Oxygen Masks for Single Use, Nasal Oxygen Cannulas for Single Use, Guedel Airways for Single Use, Laryngeal Mask Airways, Anesthesia Masks for Single Use, Breathing filters for Single Use, Breathing circuits for Single Use.
It is reported that the EU Medical Instrument Regulation MDR (EU 2017/745) came into effect on May 25, 2017, replacing the Medical Instrument Directive MDD (93/42/EEC) and the Active Implantable Medical Instrument Directive AIMDD (90/385/EEC ), aiming to establish a modernized and stricter regulatory framework to better protect the health and safety of the public and patients. Among them, MDR has put forward stricter requirements for medical instrument manufacturers in terms of product risk management, product performance and safety standards, clinical evaluation, and post-market alert and supervision. Compared with the MDD directive, the regulatory MDR has stronger supervision, more difficult certification, and pays more attention to the safety and effectiveness of products.
Kangyuan Medical has successfully obtained MDR certificate this time, which fully proves that Kangyuan products have reached the recognition of the EU and international markets in terms of production control, quality assurance and risk management.
For Kangyuan Medical, which has been deeply involved in the European market for more than ten years, the acquisition of the MDR certificate is a milestone. , Latin America and other markets provided strong support.
Post time: Feb-06-2023