Medical device business license agency

Now the business of three types of medical equipment need to be related to the license to operate. Medical devices are divided into three categories, one of which can be handled directly, the second class of medical devices need to be filed to the relevant departments to operate, the third class of medical devices must be audited by the relevant departments and issued a certificate to operate. Today we will explain how to apply for a Class III medical device license. Medical device agent is a lot of people tend to rush to the industry, of course, engaged in medical equipment agents need to meet certain conditions. The medical equipment agent's conditions are what, should have the conditions of the medical equipment agent.

Process and price of medical device licenseRequirements:

1, site requirements: office area plus warehousing area of ≥160m2 (if it is an in vitro diagnostic reagents three types of medical devices must be accompanied by a cold storage, the requirements of the more than 40m3);

2, staffing Requirements: the need to have three relevant personnel for the record and hold a certificate;

3, product requirements: there must be in line with the business scope of the product information, and the issuance of certificates;

4, other relevant laws and regulations.

Process and price of medical device licenseRequired information:

1, medical device business license application form

2, business administration issued by the business name pre-approval notification or industrial and commercial business license

3, business premises warehouse Venue documents include a copy of the property certificate or lease agreement and the lessor's property certificate;

4, business premises, warehouse layout plan.

5, the legal person in charge of the enterprise responsible for quality management of the identity of the person in charge of a copy of the certificate of academic qualifications or title certificate and biography

6, technician search list and academic qualifications, title certificates;

7, business quality management standardized document directory;

8, the enterprise has been installed in the product purchases, sales, inventory information management system, print the first page of the information management system.

9, storage facilities and equipment directory;

10, apply for a "medical device business license" confirmation.