Scope of second-class medical devices operated by retail pharmacies

X-ray filming machine, B-ultrasound, microscope and biochemical instrument belong to Class II.

The second category refers to medical devices whose safety and effectiveness should be controlled.

According to Article 30 of Chapter IV of the Regulations on the Supervision and Administration of Medical Devices, those who engage in the operation of Class II medical devices shall file a record with the food and drug supervision and administration department of the municipal people's government where they are located, and submit proof materials that meet the conditions stipulated in Article 29 of these regulations.

Twenty-ninth engaged in medical device business activities, should have the business premises and storage conditions suitable for the scale and scope of business, as well as the quality management system and quality management institutions or personnel suitable for the medical devices operated.

Extended data:

The application process of the second kind of medical devices:

1. If the application matters do not fall within the scope of functions and powers of the department according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ; ?

2. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot; ?

3. If the application materials are incomplete or do not meet the requirements of formal examination, the applicant shall issue a Notice of Supplementary Materials on the spot or within five working days to inform the applicant of all the contents that need to be supplemented at one time. If the application materials are not informed within the time limit, it will be accepted as of the date of receipt of the application materials; ?

4. If the application materials are complete and meet the requirements of formal examination, or the applicant submits all the corrected application materials as required, it shall be accepted. ?

References:

Baidu Encyclopedia-Class II Medical Equipment