Compared with the traditional means of taking medicine to treat asthma and other respiratory diseases, the medical atomizer atomizes the liquid medicine into fine particles, and the medicine enters the respiratory tract and lungs for deposition through inhalation, so as to achieve painless, rapid and effective treatment, which belongs to the second-class medical equipment.
Medical atomizer is mainly used to treat various upper and lower respiratory diseases, such as common cold, fever, cough, asthma, sore throat, pharyngitis, rhinitis, bronchitis, pneumoconiosis and other diseases in trachea, bronchi, alveoli and chest cavity.
Extended data:
The relevant requirements of medical devices stipulate that:
1. The first category of medical devices shall be subject to product filing management, and the second and third categories of medical devices shall be subject to product registration management.
2. To apply for the registration of Class II medical devices, the applicant for registration shall submit the application materials to the food and drug supervision and administration department of the local people's government of the province, autonomous region or municipality directly under the Central Government. To apply for the registration of Class III medical devices, the applicant for registration shall submit the application materials to the food and drug supervision and administration department of the State Council.
3. The product inspection report in the application materials for registration of Class II and Class III medical devices shall be the inspection report issued by the medical device inspection institution; Clinical evaluation data shall include clinical trial reports, except for medical devices exempted from clinical trials in accordance with the provisions of Article 17 of these Regulations.
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