How to divide the first, second and third categories of medical devices?

Class I, II, and III medical devices are classified according to the safety of their use.

The first category refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management. Generally, the Municipal Food and Drug Administration will approve and issue a registration certificate.

The second category refers to medical devices whose safety and effectiveness should be controlled. Generally, the Provincial Food and Drug Administration will approve and issue a registration certificate.

The third category refers to implantation in the human body; used to support and sustain life; Medical devices that are potentially dangerous to the human body and must be strictly controlled for their safety and effectiveness. Generally, the State Food and Drug Administration will approve and issue a registration certificate.

The first type is medical devices with a low degree of risk, and the implementation of routine management can ensure their safety and effectiveness.

The second category is medical devices that have a medium risk and need to be strictly controlled and managed to ensure their safety and effectiveness.

The third category is medical devices with high risk and need to take special measures to strictly control and manage them to ensure their safety and effectiveness.

To evaluate the risk degree of medical devices, factors such as the intended purpose, structural characteristics, and use methods of medical devices should be considered.

The food and drug supervision and administration department is responsible for formulating the classification rules and classification catalogue of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification catalogue.

To formulate and adjust the classification catalog, the production and operation of medical devices shall be fully heard.

Opinions of enterprises, users, and industry organizations, and refer to the practice of international medical device classification.

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled, including X-ray machines, B-ultrasound, microscopes, biochemical instruments, etc., all of which belong to Class II medical devices.

Class III medical devices refer to the highest level of medical devices, and they are also medical devices that must be strictly controlled, which refer to medical devices implanted in the human body to support and maintain life, which are potentially dangerous to the human body and must be strictly controlled for their safety and effectiveness.

Answer 3, the meaning of a class of medical devices: a class of medical devices refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management. According to the provisions of Article 5 of the Regulations on the Supervision and Administration of Medical Devices issued by the state, the state will implement classified management of medical devices.

3. The risk degree of a class of medical devices: the first class of medical devices is a low degree of risk and implements routine management.

Article 29 of Chapter IV stipulates that those engaged in medical device business activities shall have business premises and storage conditions that are suitable for the scale and scope of business, as well as suitable for the medical devices they operate.

The quality management system and quality management institutions or personnel should be used.

3. Business regulations for Class I medical devices:

1) If the filing materials meet the requirements, the food and drug supervision and administration department shall file them on the spot. Where the filing materials are incomplete or do not conform to the prescribed form, all the content that needs to be supplemented and corrected shall be notified at one time. If the filing is not granted, the filing person shall be notified and the reasons shall be explained.

3) For medical devices that have been filed, if there is a change in the content published in the filing information form and the technical requirements of the product for the record, the filing person shall submit an explanation of the change and relevant supporting documents, and submit the change of filing information to the original filing department. If the food and drug supervision and administration department meets the formal requirements of the filing materials, it shall indicate the changes in the change column and archive the filing materials.

The first type is general equipment, which is loosely managed and can also be sold in general pharmacies.

Class II equipment must apply for a business license and must have a relevant scope to sell, and the management is stricter.

Medical devices, hospital formal equipment, such as B and so on, are all Class I, out-of-hospital health care medical equipment, such as massagers, etc., are Class II.