The concept of medical devices
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items, including required computer software, that are used directly or indirectly on the human body; their effectiveness is mainly achieved through physical means, not through pharmacological, immunological or metabolic means, or although these means are involved, they only play an auxiliary role.
Purpose
1. Diagnosis, prevention, monitoring, treatment or relief of diseases;
2. Diagnosis, monitoring, treatment, relief, or functional compensation of injuries;
3. Inspection, replacement, regulation or support of physiological structures or processes;
4. Support or maintenance of life;
5. Pregnancy control;
6. Providing information for medical or diagnostic purposes by examining samples from the human body.
Classification of medical devices
Category 1
Medical devices with low risk, whose safety and effectiveness can be guaranteed by routine management. For example:
Most surgical instruments (knives, scissors, tweezers, needles, hooks), stethoscopes (non-electric), examination gloves, dental chairs, gauze bandages, breathable tape, medical centrifuges, bandages, etc.
Category II
Medical devices with medium risk that require strict management to ensure their safety and effectiveness.
For example: thermometers, sphygmomanometers, electrocardiographs, electroencephalographs, hearing aids, electric integrated operating tables, LED operating shadowless lamps, medical sanitary masks, etc.
Category 3
Medical devices with a high risk level require special measures to be strictly controlled and managed to ensure their safety and effectiveness.
For example: implantable devices, laser surgical equipment, disposable infusion sets, blood transfusion sets, CT equipment, endoscopes, high-frequency electric knives, medical magnetic resonance imaging equipment, etc.
Product registration and filing management
Class I medical devices are subject to product registration management, while Class II and Class III medical devices are subject to product registration management.
Medical device registration refers to the activity in which the medical device registrant (hereinafter referred to as the registrant) submits registration materials to the drug supervision and administration department in accordance with statutory procedures and requirements, and the drug supervision and administration department archives the submitted registration materials for future reference.
For the registration of domestic Class I medical devices, the registrant shall submit the registration materials to the department responsible for drug supervision and management at the municipal level.
For domestic Class II medical devices, the applicant submits registration information to the local provincial drug supervision and administration bureau, which will issue a medical device registration certificate after approval.
For the registration of imported Class I medical devices, the registrant shall submit the registration materials to the State Food and Drug Administration.
For domestic Class III medical devices and imported Class II and Class III medical devices, the applicant submits registration information to the State Food and Drug Administration, which will issue a medical device registration certificate upon approval.
The registration and filing of medical devices in Hong Kong, Macao and Taiwan shall be handled in the same manner as imported medical devices.
Registration Certificate and Filing Certificate Format
The format of the medical device registration certificate is uniformly formulated by the State Food and Drug Administration.
The registration certificate number is arranged as follows:
×1 Mechanical injection×2××××3×4××5××××6
×1 is the abbreviation of the location of the registration and approval department:
Among them, domestic Class III medical devices and imported Class II and Class III medical devices are marked with the word "Guo".
For domestic Class II medical devices, the abbreviation of the province, autonomous region, or municipality where the registration and approval department is located;
×2 is the registration form:
The "Zhun" designation applies to domestic medical devices;
"Jin" designates imported medical devices;
"Xu" designates medical devices from Hong Kong, Macau, and Taiwan.
××××3 is the year of first registration;
×4 is the product management category;
××5 is the product classification code;
××××6 is the serial number for the first registration.
Format of the registration certificate for Class I medical devices
Numbering: ×1 Equipment ××××2 ××××3
×1: Abbreviation of the location of the filing department.
××××2: Year of filing.
××××3: registration serial number.
