(1) the meaning of Class III medical devices: Class III medical devices is the highest level of medical devices, medical devices must be strictly controlled, refers to implanted in the human body, used to support, maintain life, the human body has a potential danger to its safety, effectiveness must be strictly controlled medical devices.
(2) the meaning of Class II medical devices: Class II medical devices means that the safety and effectiveness of medical devices should be controlled. 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 "supervision and management of medical devices regulations" issued by the state of Article V, the state will implement the classification and management of medical devices.
2, the three different levels of risk:
(1) the degree of risk of Class III medical devices: Class III medical devices is a 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 moderate risk, requiring strict control management.
(3) the degree of risk of a class of medical devices: Class I medical devices is a low degree of risk, the implementation of routine management.
3, the three business regulations are different:
(1) three types of medical devices business regulations:
The body of the business premises should be not less than 40 square meters, the use of the business premises of the branch of the legal unit should be not less than 25 square meters (except for the setup of the city across the region); hearing aid business, the business premises should be not less than 25 square meters; contact lenses and care solutions, the use of 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. The operation of single-use sterile medical devices, there should also be more than one holders of medical device quality management system internal auditor certificate of the internal auditor and other relevant application conditions.
(2) the operation of Class II medical devices:
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 operating companies 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 it to comply with the conditions of Article 29 of the Regulations.
Chapter IV, Article 29 provides that: engaged in the operation of medical devices, there should be with the scale and scope of operation of the business premises 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, 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 the need to correct all the contents. Not for the record, should be informed of the filer and the reasons.
② to be filed medical devices, food and drug supervision and management departments should be 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 published on its website. Food and drug supervision and management departments in accordance with the first class of medical devices for the record operating standards to carry out the work of the record. The filer shall mark the filing number in the medical device specification and labeling.
③ has been filed for the medical device, the record of information on the content of the table and the filing of the product technical requirements of the change, the filer shall submit the changes in the description of the situation and the relevant documents, to the original filing department to change the filing information. Food and Drug Administration for the record information in line with the formal requirements, should be set out in the change of circumstances in the change of circumstances, the record information on file.