Class II medical device refers to the need for its safety, effectiveness should be controlled medical devices, in general, the product mechanism of Class II medical devices have achieved international and domestic recognition, technological maturity.
When applying for Class II medical devices, you should apply to the drug supervision and management department of the province, autonomous region and municipality directly under the central government where the enterprise is located, and fill in the "Application Form for License of Medical Device Manufacturer". In addition, the first class medical devices refers to the "Product Quality Law", through the routine management, enough to ensure its safety, effectiveness of medical devices (such as blood pressure meter, beat the diagnostic hammer, oxygen bags, sterilizers, etc.). Class III medical devices are medical devices that are implanted in the human body, or used for life support, or have a complex technical structure, which may be potentially dangerous to the human body, and whose safety and effectiveness must be strictly controlled.
1. Made of any material, implanted in the human body.
2. Radiotherapy equipment.
3. Respiratory anesthesia equipment.
4. Extracorporeal circulation equipment.
5. X-ray, CT, ultrasound, positronic.
6. Contact with blood in the body, ultrasound imaging equipment with interventional devices, as implanted in the human body.
7. Hyperbaric oxygen chambers, infant incubators, deemed life-support products,
8. Cardiovascular endoscopy.
9. Simulation aids.
Legal basis:
Article 50 of the Regulations on the Treatment of Medical Accidents
Compensation for medical accidents shall be calculated in accordance with the following items and standards:
(1) Medical expenses: medical expenses incurred in treating the physical damage caused by medical accidents to patients shall be calculated and paid on the basis of the evidence, but not including Original disease medical expenses. If the case is closed and the patient really needs to continue treatment, it will be paid in accordance with the basic medical expenses.
(2) lost wages: the patient has a fixed income, in accordance with the fixed income of the person due to loss of work to reduce the calculation of income higher than three times the average annual wage of the employee on the ground of the occurrence of the medical malpractice, in accordance with three times the calculation; no fixed income, in accordance with the medical malpractice occurs on the ground of the average annual wage of the employee calculation.
(3) Hospitalized meal allowance: calculated in accordance with the standard of meal allowance for the general staff of the state organs in the place where the medical malpractice occurred.
(4) escort fee: the patient needs to be accompanied during hospitalization, according to the average annual salary of the employee in the year where the medical incident occurred.
(v) Disability living allowance: according to the disability grade, calculated in accordance with the average annual cost of living of the residents in the place where the medical malpractice occurred, with a maximum compensation of 30 years from the month of determination of the disability; however, for those over 60 years of age, it shall not be more than 15 years; and for those over 70 years of age, it shall not be more than 5 years.
(F) Disease Appliance Fee: If you need to configure compensatory functional appliances due to disability, with the certificate of the medical institution, the fee will be calculated according to the cost of universal appliances.
(vii) Funeral expenses: calculated in accordance with the standard of funeral expenses subsidy stipulated by the place where the medical incident occurred.
(viii) Dependents' living expenses: to the extent of the deceased's life or the disabled person before the loss of working capacity to actually support the person who is unable to work, in accordance with the minimum standard of subsistence guarantee for residents of the place of domicile or residence. For those who are under 16 years of age, they shall be supported until they reach 16 years of age. For those who have reached the age of 16 but are incapable of labor, they shall be supported for 20 years; however, if they are over 60 years of age, they shall not be supported for more than 15 years; if they are over 70 years of age, they shall not be supported for more than 5 years.
(ix) Transportation fee: calculated according to the actual necessary transportation cost of the patient, and paid with the evidence.
(j) Accommodation expenses: calculated in accordance with the standard of business trip accommodation allowance for the general staff of the state organs in the place where the medical malpractice occurs, and paid on the basis of supporting documents.
(xi) compensation for moral damage: calculated in accordance with the average annual cost of living of residents in the place where the medical malpractice occurred. Causing the death of the patient, the compensation for up to six years; causing the patient's disability, the compensation for up to three years.