How to Apply for a Second Category of Medical Device Filing? What Information and Processes Are Need

  Author:MeCan Medical–ultrasound machine manufacturers

my country is classified in accordance with the degree of risk of medical devices in accordance with the degree of risk, and manages the first, second, and third categories. One category does not require qualifications to operate, and the third category needs to be approved, and the second category is also commonly done. It needs to be recorded. Whether it is online or physical store sales, the second category of medical enterprises must apply for the second category of medical equipment. Only to operate, so how to handle the filing of second category of medical equipment? What information and processes are needed?

Requirements for the filing of second categories of medical equipment:

1. As a rear approval qualification, the business license must be completed first;

2. There are two types of medical projects within the business scope;

3. Have actual office space;

4. Employees with qualifications.

The information required for the filing of the second category of medical device:

1. Business license, official seal;

2. Red Paper Leasing Voucher (Certificate of Use);

3. Copy of ID cards and qualifications of legal representatives, personnel in charge, and quality leaders (at least college degree or above, legal person representatives can serve as the person in charge of the enterprise, at least 2 personnel);

4. Registered address location and venue floor plan.

Processing the filing process of second category of medical equipment:

1. Entering the second category of medical device service platforms for the local market supervision bureau, you can check all the details of the handling;

2. Log in to use the legal person's account, that is, the account number used by the registered company, because it is necessary to connect the corporate information before it can be handled;

3. You can issue a second category of medical filing certificate, print (black and white) by yourself, and post it in a significant position in the business place.

The above is the information and processes required for the filing of second -class medical equipment.

How to Apply for a Second Category of Medical Device Filing? What Information and Processes Are Need 1

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