Shenzhen Category II、Conditions and address requirements for handling Class III medical devices!

Shenzhen Category II、Conditions and addresses for handling Class III medical devices

Require

! Shenzhen Category II、Conditions and addresses for handling Class III medical devices! Do you really understand it? one、Medical device registration

Advantages

：

1. resource

Advantages

：Commercial buildings can be used as registration sites for medical device companies。

1. Apply for certificate

Advantages

：Has considerable experience in handling medical device licenses，There are currently more than 300 companies。

1. Popularity

Advantages

：The certification staff of the drug regulatory department have maintained good performance for a long time、Harmonious work relationship 2、handle

Require

：

1. site

Require

，Office area plus storage area ≥ 160㎡ (if it is an in vitro diagnostic reagent type III medical device, it must have a cold storage，

Require

Above 40㎡)；

1. personnel

Require

：3 relevant personnel are required to be registered and hold certificates；

1. product

Require

：There must be product information that is consistent with the business scope；

1. Other relevant laws and regulations

Require

； three、Process information：

1. "Medical Device Business Enterprise License Application Form"；
2. "Notice of Preliminary Approval of Enterprise Name" issued by the industrial and commercial administration department or,"Industrial and Commercial Business License"；
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、Identity certificate of quality manager、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；
11. Quality management personnel’s on-the-job self-assurance statement and self-assurance statement on the authenticity of application materials，Including the catalog of application materials and the company's commitment to bear legal responsibility if the materials are false.；
12. Apply for a confirmation letter of "Medical Device Business Enterprise License"。

Four、

Process

：

1. Applicants submit application materials to relevant departments；
2. Relevant departments accept applicants’ applications；
3. Go to the actual site to conduct surveys and review products；
4. Approved to issue Class III medical device license；
5. Issuance of Class III medical device license。

five、What does the full set of licenses for Shenzhen medical device companies include?：

1. Business license is correct、copy
2. Organization code certification、copy
3. Organization code IC card
4. Correct tax registration certificate、copy
5. Original and duplicate of medical device business license or medical device business registration certificate
6. official seal、financial chapter、Corporate emblem、A set of shareholder seals
7. Basic account license，Bank letter of credit. The above is the relevant information and processing of Hong Kong Xintong-I introduced to you about applying for Class III medical device license in Shenzhen.

Require

。

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