China Announces the Release of 20 New Medical Device Industry Standards
The National Medical Products Administration (NMPA) of China has announced the release and implementation of 20 new medical device industry standards, including the revised standard for all-glass syringes, YY 1001-2024, which supersedes YY 1001.1—2004 and YY 1001.2-2004. This announcement was made on February 19, 2024, through Notice No. 16 of 2024.
The updated and newly established standards cover a wide range of medical devices and technologies, including diagnostic X-ray equipment, infrared coagulation therapy devices, performance requirements and test methods for degreased cotton and rayon blends, laser surgery-specific tracheal tubes, dry chemistry analyzers, cardiovascular implantable devices, medical varicose vein compression stockings, glucose test kits (enzymatic method), ureaplasma urealyticum nucleic acid test kits, calibration substances for biochemical analyzers, medical mass spectrometers, image quality evaluation methods for X-ray computed tomography (CT) under automatic exposure control, and various other specialized medical instruments and devices.
These standards have been revised or established to improve the quality and safety of medical devices, ensuring they meet the latest technological and regulatory requirements. The implementation of these standards is expected to have a significant impact on the medical device industry in China, enhancing product performance and patient safety.
TX Medical has played a role in assisting with the establishment of medical standards in China and consistently reminds clients to pay attention to standard upgrades, advising them to check if there is a need to update the technical requirements of their registration certificates. For any inquiries, contact can be made via contact@txcro.com.