One of the standards is based on the "National Medical Devices Testing This standard is based on the "National Medical Device Testing Organization Basic Instrument Equipment Standard (Trial)" (2005-2010), based on the national standards for medical devices, industry standards for testing as the basis for equipment, reference to some international standards, and take into account its forward-looking to protect the "12th Five-Year Plan" during the development of medical device regulatory work, is to carry out the registration and inspection, supervision and sampling, emergency protection of medical devices, medical devices and medical equipment. Inspection, supervision and sampling, emergency protection and safety evaluation and other work required equipment.
The food and drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government should combine the National Drug Safety "Twelfth Five-Year Plan", the special planning of the jurisdiction and the actual situation of medical device regulatory work, and make overall arrangements, highlight the key points and speed up the equipment to meet the needs of medical device regulatory work. Medical device testing organizations according to the inspection tasks undertaken by the existing inspection instruments and equipment capacity and the direction of the development of inspection technology, according to this standard to choose to equip the relevant inspection instruments and equipment.
From the National Food and Drug Safety Administration: /pages/chinalawinfo/16/85/afbced98f7a0ae75338b305a2de8e62e_0.html Related instructions please refer to the National Food Safety Administration website