Two categories: surgical instruments, 6815 injection and puncture instruments, 6820 general diagnostic instruments, 6821 medical electronic instrumentation and equipment, 6822 medical optical and endoscopic equipment, 6823 ultrasound instrumentation and equipment for medical use, 6824 medical laser instrumentation and equipment, 6825 medical high-frequency instrumentation and equipment, 6826 physical therapy and rehabilitation equipment, 6827 Chinese medicine instruments, 6828 medical magnetic **** vibration equipment, 6824 Medical laser instruments and equipment, 6825 medical high-frequency instruments and equipment, 6826 physical therapy and rehabilitation equipment, 6827 traditional Chinese medicine instruments, 6828 medical magnetic **** vibration equipment, 6830 medical X-ray equipment, 6831 medical X-ray accessory equipment and components, 6833 medical nuclide equipment, 6834 medical radiation protection supplies, devices, 6840 clinical test and analysis instruments (in vitro) Diagnostic reagents limited to early and early pregnancy test strips, ovulation test strips, urine glucose test strips, blood glucose test strips), 6841 Medical laboratory and basic equipment, 6845 Extracorporeal circulation and blood processing equipment, 6846 Implantable materials and artificial organs, 6854 Operating theaters, first aid rooms, diagnostic and therapeutic room equipment and appliances, 6855 Stomatological equipment and appliances, 6856 Ward care equipment and appliances, 6857 Disinfection and Sterilization equipment and appliances, 6858 medical cold therapy, low temperature, cold storage equipment and appliances, 6863 stomatology materials, 6864 medical hygiene materials and dressings, 6865 medical suture materials and adhesives, 6866 medical polymer materials and products, 6870 software Class II medical device record business scope.
The scope of business of Class II medical devices refers to the scope of business that needs to be met to operate Class II medical devices. For medical device operators, it is vital to understand and comply with the provisions of the scope of business of Class II medical devices. This is because different types of medical devices have different safety and efficacy requirements, and only by complying with the relevant regulations can the quality and safety of the products be ensured. In addition, the scope of Class II medical device business is also an important basis for the change of registration of medical device registration certificate and the annual inspection of the business license.
Summary of the above is the editorial class II filing 6840 business scope to make the relevant answers, I hope to help you.
Legal basis
"Supervision and Administration of Medical Devices Regulations" Article XVI apply for registration of Class II medical device products, the registration applicant shall submit the registration application information to the people's government of the province, autonomous region and municipality directly under the Central People's Government of the People's Republic of China drug supervision and management department. Apply for Class III medical device[4] product registration, the applicant for registration shall submit the registration application information to the State Council Drug Administration.