1, the meaning of the three different:
(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 the implantation of 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 device: Class II medical device 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, the fifth article, 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 with medium risk, need to take strict control 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.
3, the three business regulations are different:
(1) three types of medical devices business regulations:
The body should be no less than 40 square meters of business premises area, the use of legal entity branches of the business premises area should be no less than 25 square meters (except for the set up of the city of the cross district); business hearing aid, the use of the premises area should be no less than 25 square meters; contact lenses business should be no less than 25 square meters; the business contact lenses business should be no less than 25 square meters. Square meters; contact lenses and care solutions, the 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 education or related professional technical title above the intermediate level. Operation of single-use sterile medical devices, there should be more than one medical device quality management system should hold a certificate of 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 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 filing 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 the need to make corrections to all the contents. Not for the record, shall inform the filer and explain 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 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 operating standards to carry out the work of the record. 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 shall submit a description of the changes and relevant documents to the original filing department to change the filing information. Food and drug supervision and management department of the filing information in line with the formal requirements, should be in the change of circumstances in the change of circumstances contained in the column, the filing information will be archived.