A: The business license of Class I medical devices includes basic surgical devices, microsurgical devices, neurosurgical devices, ophthalmic devices, otolaryngology devices, stomatological devices, thoracic cardiovascular surgical devices, abdominal surgical devices, anorectal surgical devices, orthopedic (plastic) surgical devices, gynecological surgical devices, family planning surgical devices, injection puncture devices and burn (plastic) surgical devices. General diagnostic instruments, medical electronic instruments and equipment, medical optical instruments, instruments and endoscopic equipment, medical ultrasonic instruments and related equipment, medical laser instruments and equipment, medical high-frequency instruments and equipment, physiotherapy rehabilitation equipment, medical magnetic vibration equipment, medical X-ray equipment, medical X-ray accessory equipment and parts, medical radionuclide equipment, medical radiation protection articles, devices, clinical inspection and analysis instruments, medical laboratory inspection and basic equipment, Extracorporeal circulation and blood treatment equipment, implant materials and artificial organs, operating room, emergency room, outpatient equipment and appliances, oral equipment and appliances, ward nursing equipment and appliances, disinfection and sterilization equipment and appliances, medical cold therapy, low temperature and refrigeration equipment and appliances, oral materials, medical sanitary materials and dressings, medical suture materials and adhesives, medical polymer materials and products, interventional equipment.

Legal basis: Article 4 Medical device standards are divided into mandatory standards and recommended standards according to their effectiveness.

The technical requirements for protecting human health and life safety should be formulated as mandatory national standards and mandatory industry standards for medical devices.

It meets the technical requirements of basic universality, matching with mandatory standards and playing a leading role in the medical device industry, and can be formulated as recommended national standards and recommended industry standards for medical devices.

Article 5 Medical device standards are divided into basic standards, method standards, management standards and product standards according to the standardization objects.