Legal analysis: you can check. In recent years, the State Drug Administration each year to organize the preparation and revision of about 100 medical device standards, the major basic standards, general standards, high-risk product standards, standards in areas related to strategic emerging industries priority projects. Up to now, the current effective medical device standards *** 1791, of which 227 national standards (93 mandatory standards, 134 recommended standards), industry standards 1564 (303 mandatory standards, 1261 recommended standards). In order to facilitate the use of the standard query, the above 1791 standards in accordance with the general technical areas and professional and technical areas of the arrangement, the general technical areas are subdivided into the quality management of medical devices, medical devices, the only marking of medical devices, medical devices, packaging, medical devices, biological evaluation of medical devices, general requirements for medical electrical equipment, general technology of disinfection and sterilization and other 7 parts, professional and technical areas are subdivided into surgical instruments, Medical biological protection, medical X-ray equipment and appliances, medical laboratory and in vitro diagnostic devices and reagents and other 32 parts. The basic principle of standard arrangement is: the first national standards and then industry standards; standards at the same level according to the standard number sequence; professional and technical areas of standards first general standards, after the product standards, method standards, series or similar standards side by side. Part of the series of standards due to different areas of specialization, has been integrated or revised reasons, the series standard number may not be completely coherent.
Legal basis: "Chinese people's **** and the State Drug Administration Law" Article 12 of the State to establish and improve the drug traceability system. The drug supervision and management department of the State Council shall formulate unified standards and norms for drug traceability, promote the sharing of drug traceability information, and realize the traceability of drugs. The state establishes a pharmacovigilance system to monitor, identify, evaluate and control adverse drug reactions and other harmful reactions related to the use of medicines.