The Songjiang two, three types of medical equipment business license

Shanghai Songjiang District, three types of medical equipment license conditions and information

Medical business license a **** there are three types, which for a class of medical equipment license can be directly for the operation of the second class of products is required to apply for the second class of medical equipment business filing certificates, the operation of the third class of products need to apply for the third class of medical equipment business license.

Medical device license for three kinds of business conditions:

1, the business license business scope includes medical equipment business (sales)

2, with the scope of business and business scale appropriate quality management institutions or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles;

3, with the scope of business and business scale appropriate business, storage and storage premises. Business, storage space;

4, with the scope and scale of business storage conditions, all entrusted to a third-party medical device business enterprises can not set up storage;

5, with the operation of medical devices appropriate quality management system;

6, with the operation of medical devices appropriate professional guidance, technical training and after-sales service capacity, or Agree to provide technical support by third-party organizations.

What is the information required to obtain a Class III medical device license?

1. Medical device license application form;

2. Business license;

3. Legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the certificate, a copy of the certificate of qualifications or titles;

4. Organizational and departmental setup instructions;

5. Scope of business, the business mode of operation description;

6. The business premises, the depot address of the location of the map, Floor plan, documents proving property rights or lease agreement (with documents proving property rights) copies of the warehouse entrusted to a third party needs to be entrusted by the third party warehousing agreement;

7. Business facilities, equipment directory;

8. Business quality management system, work procedures and other documents directory;

9. Proof of authorization of the operator, a letter of commitment.

Medical devices three types of business license cycle:

The information meets the requirements, the closing time limit of about 20 working days.