How Much Do You Know About Medical Device Qualifications?

  Author:MeCan Medical–ultrasound machine manufacturers

There are more and more subjects engaged in the production, sales and operation of medical device, and the industry ecology is also continuously improved under policy orientation. So what qualifications do they need to apply for medical device products? Can medical device qualifications be held on behalf of? In response to these issues, let's follow the editor of Proven Medical Devices to learn about it.

1. What are the medical qualifications?

1. Medical Device Operation Second Category Filial Permit, Medical Device Management Third Class of Licensing Certificate, Medical Device "In vitro Diagnostic Reagents" cold storage installation, insulation box, temperature and humidity monitoring system. Medical Device Class production filing, medical device III production license, medical device Class product filing certificate, medical device IIII product registration certificate.

2. Is the second or third medical device changed after the business license legal person change?

No need to re -apply, but you need to prepare relevant information to be uploaded on the Internet to change.

The materials needed for changes required for the third, second and third categories of medical qualification addresses?

Change the application form, the new address real estate information (lease agreement), the equipment directory, the geographical location map plan, the trustee's attorney client commission, the original three types of medical qualification certificates, the material authenticity guarantee statement and the new business license.

Fourth, can medical device qualifications be held on behalf of?

At this stage, the qualifications for medical device can be selected to handle, or you can entrust your office office to handle it. Due to more procedures. The process is relatively complicated, and the time it takes for a long time is also a long time.

How Much Do You Know About Medical Device Qualifications? 1

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