The Department of Comprehensive Division of the State Drug Administration on the car sales enterprise operates whether the ambulance containing medical device products should apply for business qualifications

Heilongjiang Provincial Drug Administration:

Your bureau's "Request to the Ambulance in Automobile Sales Enterprises Contains Medical Device Products Should Apply for Business Qualifications" is received. After studying, the letter was followed as follows:

1. According to Article 41 and Article 42 of the "Regulations on the Supervision and Administration of Medical Device", those who are engaged in the operation of the second type of medical device shall be responsible for the department of the municipal -level people's government in the place where they are located. File; those who are engaged in the operation of the third category of medical device, shall apply to the municipal -level people's governments where the municipal -level people's governments are located in the city -level people's government.

The ambulance mentioned in the letter is not managed in accordance with the medical device, and the phlegm, the defibrillation, and the ventilator are managed in accordance with the medical device. Management of medical devices shall handle the corresponding qualifications according to law.

2. According to Article 45 of the Regulations on the Supervision and Administration of Medical Devices, medical device business enterprises and use units shall purchase medical devices from medical device registrations, recorders, and production and operation enterprises with legal qualifications. When purchasing medical devices, you should check the qualification documents of the supplier and the qualified certificate of the medical device, and establish a purchase inspection record system. When purchasing medical devices in the use unit in the letter, the purchase obligation obligations shall be fulfilled in accordance with the law.

I have recovered.

Comprehensive Department of the State Drug Administration

August 31, 2022

Source: Website of the State Drug Administration

- END -