Class II: Surgical Instruments, 6815 Injection and Puncture Instruments, 6820 General Diagnostic Instruments, 6821 Medical Electronic Instruments and Equipment, 6822 Medical Optical Instruments and Endoscopic Devices, 6823 Medical Ultrasonic Instruments and Equipment and Related Devices, 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 Appurtenances and Components, 6833 Medical Nuclide Equipment, 6834 Medical Radiation Protection Supplies, Devices, 6840 Clinical Testing and Analyzing Instruments (In Vitro Diagnostic Reagents Limited to Early and Early Pregnancy Test Strips, Ovulation Strips, Urine Sugar Test Strips, Blood Sugar Test Strips) test strips, ovulation test strips, urine glucose test strips), 6841 Medical laboratory and basic equipment, 6845 Extracorporeal circulation and blood processing equipment, 6846 Implantable materials and artificial organs, 6854 Operating room, emergency room, diagnostic and treatment room equipment and appliances, 6855 Dental equipment and appliances, 6856 Ward care equipment and appliances, 6857 Sterilizing and disinfecting equipment and appliances, 6858 Cold therapy, cryogenic, refrigeration equipment and appliances, 6863 Dental equipment and appliances, 6868 Cold therapy equipment and appliances, 6863 Oral 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 filing business scope.
Simply put, Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.
For the business scope of Class II medical devices, the law has clear provisions, such as 6815 injection and puncture instruments, 6820 general diagnostic instruments, 6830 medical X-ray equipment, 6831 medical X-ray accessory equipment and components and so on. Generally speaking, the determination of the second class of medical equipment should be the first compared to the operation of medical equipment is the existence of this regulation inside the type. That is to say, the scope of business is this regulation inside the class II medical equipment.
Overseas applicants for registration of Class II and Class III medical devices exported to China, the designated enterprise legal person in China to the State Council Drug Administration to submit the application for registration and the registration of the applicant's country (region) competent authorities to authorize the sale of the medical device on the market documents. Not in the overseas market of innovative medical devices, can not submit the registration applicant's country (region) competent authorities to authorize the marketing of the medical device documents.
The State Council Drug Administration shall make provisions for medical device registration review procedures and requirements, and strengthen the provincial, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management department of the registration review supervision and guidance.
Engaged in the second class of medical devices business, business enterprises should be located in the municipal food and drug supervision and management department for the record, fill out the second class of medical devices business filing form. Now in Taobao, Tmall, Jingdong and other e-commerce platforms to open a store to sell Class II medical devices, to first apply for Class II medical device business filing vouchers, and then the network sales record.
Since June 1, 2014, engaged in the operation of Class II medical devices, operating companies should fill out the Class II medical device business filing form to the location of the municipal food and drug supervision and management department for the record, and submit the filing materials in line with the requirements of the Class II medical device business filing materials.
Receiving medical device business filing materials, municipal food and drug supervision and management departments should be field on the integrity of the filing materials for verification, in line with the prescribed conditions to be filed, issued by the second class of medical equipment business filing vouchers).
Legal basis:
"Supervision and Administration of Medical Devices Regulations" Article 16 Application for registration of Class II medical device products, the applicant for registration shall be located in the provinces, autonomous regions, municipalities directly under the Central People's Government of the People's Government of the drug supervision and management department to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit the registration application information to the State Council Drug Administration.