How long is the application period for a Class III medical device business license?

According to the relevant provisions of the Measures for the Supervision and Administration of Medical Device Operations，Enterprises that need to engage in the operation of Class III medical devices，Relevant materials should be submitted to the local districted municipal food and drug administration department to apply for a Class III medical device business license.。

Generally speaking，Personnel applying for a Class III medical device business license should have corresponding professional knowledge，How long does it take to apply for a Class III medical device business license? Be familiar with the laws governing medical device business licenses.、regulations、regulations and technology

Require

。

Materials required for Category II application filing：

1. Class II medical device business registration form；
2. Copies of business license and organization code certificate；
3. Identity and academic qualification certificate of the legal representative or person in charge of the enterprise；
4. Description of corporate organization and department settings；
5. Business scope、Method description；
6. Business premises、Warehouse address rental voucher、House property ownership documents；
7. Business premises、Facilities at warehouse address、is cataloged；
8. Certificate of authorization of the person in charge；How long is the application period for a Class III medical device business license?
9. Commitment materials for the authenticity of application materials，Signature and seal of legal person；
10. Other supporting materials。

Conditions for applying for a medical device business license for Category III：1.Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business。

Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；How long is the application period for a Class III medical device business license?

1. Have a relatively independent business location that is commensurate with the business scale and scope of business；
2. Have storage conditions suitable for the business scale and business scope，Including products that comply with the characteristics of medical devices

Require

storage facilities、equipment；

1. A sound product quality management system should be established，including procurement、Incoming goods acceptance、Warehousing and storage、Warehouse review、Quality tracking and adverse event reporting system, etc.；
2. Should have technical training and after-sales service capabilities suitable for the medical device products it operates.，Or agree to have a third party provide technical support；
3. Companies operating sterile and implantable products need to establish computer management systems and computer management systems，Able to ensure effective quality tracking and traceability of products throughout the entire process from purchase to sale.。

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