Requirements for applying for a Class III medical device business license

Apply for a Class III medical device business license

Require

Medical device business license is divided into one category，Category II and III。These three categories

Require

They are all different，If you want to sell medical devices online or in stores，A medical device business license is required。

one、Apply for a Class III medical device business license

Require

：

1. There are office spaces and warehouses，The office address is larger than 100 square meters，Warehouse address is larger than 60 square meters，If there are in vitro diagnostic reagents, cold storage is required，and greater than 40 cubic meters。
2. There are three relevant people，Relevant certificates are required。
3. Product certificates for the products being sold。
4. Other relevant laws and regulations

Require

。

two、Information required to apply for a Class III medical device business license：

1. "Medical Device Business Enterprise License Application Form"。
2. "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department。
3. Application report。
4. Business premises、Documentation proving the warehouse location，Include a copy of the property certificate or lease agreement and the lessor’s property certificate。
5. Business premises、Warehouse layout plan。
6. Person in charge of formulating the law、Business person in charge、Quality manager’s ID card、Copy of academic certificate or professional title certificate and resume。
7. Technical personnel search list and academic qualifications、Copy of professional title certificate。
8. Business quality management specification document directory。
9. Enterprise installed product purchases、pin、stored information management system，Print the home page of the information management system。
10. Warehousing Facility Equipment Catalog。

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