The scope of Class I medical devices includes medical devices whose safety and efficacy can be guaranteed by the routine management of the relevant departments. In addition, according to Article 5 of the Regulations for the Supervision and Administration of Medical Devices issued by the state, the state will implement classification and management of various types of medical devices to ensure the safety of Class I medical devices.
What products are included in Class I, Class II and Class III medical devices?
1, a class - do not have to apply for a medical device license Class I medical device is a low-risk, routine management can ensure the safety and effectiveness of medical devices, such as: surgical instruments, scraping board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags and so on. Its products and production activities by the location of the municipal food and drug regulatory authorities to implement record management. Business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector can be. If the production of a class of medical devices for the enterprise then for the first class of medical equipment products for the record and production can be filed!
2, Class II - City Drug Administration for the medical device business filing Class II medical devices is a medium risk, need to strictly control the management in order to ensure its safety and effectiveness of medical devices, such as our daily life common medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalogram machines, microscopes, acupuncture Needles, biochemical analysis systems, hearing aids, ultrasound sterilization equipment, non-absorbable sutures, condoms, etc., the products and production activities by the provincial food and drug regulatory authorities to implement licensing management, respectively, issued by the "Medical Device Registration Certificate" and "Medical Device Manufacturing License". Business activities by the municipal food and drug regulatory departments to implement record management;
3, Class III - State Drug Administration for medical device license Class III medical devices are higher risk, need to take special measures to strictly control the management of medical devices to ensure their safety and effectiveness of its products and production and management activities respectively, by the State Administration, provincial food and drug regulatory authorities and municipal food and drug regulatory authorities to implement licensing and management, respectively, issued by the "Medical Device Registration Certificate", "Medical Device Manufacturing License", "Medical Device Business License".
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices," Chapter II, Article 8, a class of medical devices for the record for management. Chapter III, Article 21: engaged in the production of a class of medical devices, by the production of enterprises to the location of the municipal food and drug supervision and management department for the record and submit its compliance with the conditions of Article 20 of these regulations.