Can retail pharmacies record the operation of Class II medical devices?

Engaged in the second kind of medical device business, the business enterprise shall file with the food and drug supervision and administration department of the municipal people's government where the district is located, and submit the certification materials that meet the conditions stipulated in Article 29 of these regulations.

When purchasing medical devices, medical device business enterprises and users shall check the supplier's qualification and medical device qualification certificate, and establish a record system for incoming inspection. Enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices shall also establish a sales record system.

Extended data:

Medical device management requirements:

1. The transportation and storage of medical devices shall meet the requirements of instructions and labels of medical devices; If there are special requirements for environmental conditions such as temperature and humidity, corresponding measures should be taken to ensure the safety and effectiveness of medical devices.

2. Users of medical devices shall have storage places and conditions suitable for the variety and quantity of medical devices in use. Units using medical devices shall strengthen technical training for employees and use medical devices in accordance with the requirements of product specifications and technical operation specifications.

3. Users of medical devices should check, inspect, calibrate, maintain and record the medical devices that need regular inspection, calibration and maintenance according to the requirements of product specifications, and make analysis and evaluation in time to ensure that the medical devices are in good condition and ensure the quality of use.

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