How to identify Class I and Class II medical devices

The difference between Class I and Class II of medical devices is: medical devices are different according to the degree of risk.

1. The first category is medical devices with a low degree of risk and routine management that can ensure their safety and effectiveness.

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

3. 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.

Extended information: 1. For the filing of Class I medical device products, the filing person shall submit the filing materials to the local food and drug supervision and administration department of the people's government divided into districts.

2. Overseas manufacturers that export Class I medical devices to China shall be subject to the representative office established in China or the designated enterprise legal person in China as the first person, and submit the filing materials and the certification documents of the competent department of the country (region) where the filing person is located to allow the medical device to be marketed and sold to the food and drug supervision and administration department.

3. To apply for the registration of Class II medical device products, the registration applicant shall submit the registration application materials to the people's food and drug supervision and administration department of the province, autonomous region and municipality directly under the Central Government.

The first category refers to medical service devices that can ensure their safety and effectiveness through routine education management.

The second category refers to medical devices that control safety and efficacy.

Class I medical devices include: basic surgical knives, peel knives, lancets, shovel blades, scalpel handles and blades, etc.

The second class of medical devices includes: ordinary instruments including thermometers and blood pressure monitors, physical equipment including magnetic therapy equipment, clinical laboratory and analysis instruments including household blood glucose analyzers and test strips, operating rooms, emergency rooms, and diagnosis and treatment room equipment and appliances.

There are instructions on the outer label of the product packaging.

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.

Article 5 The medical device registration certificate shall be uniformly printed by the State Food and Drug Administration, and the corresponding content shall be filled in by the (food) drug supervision and administration department for approval and registration.

The registration number is arranged in the following way:

1 (Food) Drug Administration (2) Zi 3 No. 4 5 6. Where:

1 is the abbreviation of the location of the registration and approval department:

Domestic Class III medical devices, overseas medical devices, and medical devices in Taiwan, Hong Kong, and Macao are the word "country";

The second class of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the registration and approval department is located;

The abbreviation of the province, autonomous region and municipality directly under the Central Government where the registration and approval department is located plus the abbreviation of the administrative area of the city divided into districts is 1 (if there is no corresponding administrative area of the city divided into districts, it is only the abbreviation of the province, autonomous region and municipality directly under the Central Government);

2 is the form of registration (quasi, enter, permit):

The word "quasi" applies to domestic medical devices;

The word "in" applies to overseas medical devices;

The word "Xu" is applicable to medical devices in Taiwan, Hong Kong and Macao;

3 is the year of approval of registration;

4 is the product management category;

5 is the product variety code;

6 is the registration serial number.

The medical device registration certificate is attached to the Medical Device Registration Form (see Annex 1 of these measures), which is used at the same time as the medical device registration certificate.

Nos. 4, 5, 6, 4 are the product management categories; Class 1 Class 2 Class 2 Class 3 3

To put it simply, the country is the third category, the province is the second category, and the city is the first category.