There are 3 differences between Class III medical devices, Class II medical devices, and Class I medical devices:
I. The meaning of the three is different:
1. The meaning of Class III medical devices: Class III medical devices are the highest level of medical devices, and medical devices that must be strictly controlled, which refers to the implantation of the human body, for the purpose of supporting and sustaining life, and are potentially dangerous to the human body, and the safety and effectiveness must be strictly controlled. Safety and effectiveness of medical devices must be strictly controlled.
2, the meaning of Class II medical devices: Class II medical device means that its safety, effectiveness should be controlled medical devices. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.
3, the meaning of a class of medical devices: Class I medical device means that the routine management is sufficient to ensure its safety and effectiveness of medical devices. According to the state issued the "supervision and management of medical devices regulations" the provisions of Article V, the state will implement the classification of medical devices management.
Two, three different levels of risk:
1, the degree of risk of Class III medical devices: Class III medical devices are with higher risk, need to take special measures to strictly control the management.
2, the degree of risk of Class II medical devices: Class II medical devices is a medium risk, requiring strict control and management.
3, the degree of risk of Class I medical devices: Class I medical devices is a low degree of risk, the implementation of routine management.
Three, the three business regulations are different:
1, three types of medical devices business regulations:
(1) the business premises should be no less than 40 square meters, the use of legal entity branches of the business premises should be no less than 25 square meters (except for the setup of the city across the region); business hearing aids, the business premises should be no less than 25 square meters of business premises. Square meters; contact lenses and care solutions, business premises should be no less than 10 square meters.
(2) warehouse area should be not less than 30 square meters; the operation of single-use sterile medical devices, the warehouse should be in the same building, the use of the area should be not less than 200 square meters.
(3) quality management, quality institutions should have a nationally recognized, and business products related to the profession, college degree or above, or intermediate or higher technical title in related disciplines. Operating single-use sterile medical devices, there should be more than one medical device quality management system internal auditor certificate of internal auditor and other relevant application conditions.
2, Class II medical device business regulations:
According to the "supervision and management of medical devices regulations" Chapter IV, Article 30 provides that: engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of the municipal people's food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 29 of the Ordinance.
Chapter IV, Article 29 provides that: engaged in the operation of medical devices, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
3, a class of medical devices business regulations:
(1) the record information meets the requirements of the food and drug supervision and management department shall be filed on the spot. Record information is incomplete or does not meet the prescribed form, it should be informed of all the contents of the need to make corrections. Not for the record, shall inform the filer and explain the reasons.
(2) to be filed for medical devices, food and drug supervision and management departments should be made in accordance with the relevant requirements of the format of the record voucher, and will be filed in the information contained in the information table on its website to be published. Food and drug supervision and management departments in accordance with the first class of medical devices for the record operation specification to carry out the filing work. The filer shall mark the filing number in the instructions and labeling of medical devices.
(3) has been filed medical devices, filing information on the content of the table and the filing of the technical requirements of the product changes, the filer should be submitted to the change in the description of the situation and the relevant documents, to the original filing department to change the filing information. Food and drug supervision and management department of the filing of information in line with the form requirements, should be set out in the change of circumstances in the change of circumstances, the filing information will be archived.
Extended Information
Production of Class II and Class III medical devices should be clinically validated. If the production of Class III medical devices, as said, by the State Council drug supervision and management department for examination and approval, and issued a certificate of registration for the production of products.
Class III medical devices, such as artificial heart valves, artificial joints, vascular stents, implanted in the human body hemostatic gauze and so on.
Note that there are many hemostatic gauze, soluble hemostatic gauze on the market now, but only three types can be implanted in the body, absorbed by the body, do not have to take out of the class II hemostatic gauze can only be used for the body surface, although the second type of manufacturers to publicize can be used in the body, but is not in line with the law, but also prone to problems.
Currently, the state of the third class of medical devices safety and effectiveness to take strict control management.
Baidu Encyclopedia - Class III Medical Devices
Baidu Encyclopedia - Class II Medical Devices
Baidu Encyclopedia - Class I Medical Devices
Baidu Encyclopedia - Medical Devices