How to apply for medical equipment business enterprise?

Wuhan City, Hubei Province, on the drug wholesale enterprises have been restricted to new start-ups, medical equipment, new start-ups are also sometimes in the limitations of the previous 2 years seems to require the start-up of new medical equipment business wholesale enterprises to apply for must be operating high-tech class of devices to be eligible to apply for this year, I don't know, this is to go to the fair road of the Provincial Bureau of Pharmaceutical Supervision to ask, in addition to the scope of the business you want to be ready to do business, according to the scope of your proposed business, the requirements are different. You proposed business scope, the requirements are different, a class of medical devices do not need a license, but to Wuhan City Drug Administration to record, class 2 class 3 devices need to go to the provincial Drug Administration for a license.

Apply for a "medical device business license" should have the following conditions: (a) with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have nationally recognized professional qualifications or titles. (B) with the scale and scope of operation of relatively independent business premises. (C) with the scale and scope of operation of the storage conditions, including the characteristics of medical devices with the requirements of storage facilities, equipment. (D) should establish and improve product quality management system, including procurement, purchase and acceptance, warehousing, storage, review, quality tracking system and adverse event reporting system. (E) should have the ability to operate its medical device products with appropriate technical training and after-sales service, or agreed by a third party to provide technical support;

Additionally, you are advised to go to the provincial Food and Drug Administration guide to look at, which need to apply for a license for specific matters, including the standard format and form of the materials to be declared, as well as the license you will be faced with the certification of the scene! The standard of the inspection.

I'll send you a catalog of filing materials. Specifically, you can download the provincial bureau website, there is no understanding in the ask me.

1. Enterprise application report;

2. "Medical Device Business License Application Form";

3. Pre-approval of the business name issued by the administrative department for industry and commerce to prove the document; if the branch to provide the parent company's "Business License," "Medical Device Business License," a copy of the parent company's letter of authorization or letter of attorney;

4. p>4. the proposed enterprise responsible person and quality management personnel fact sheet;

5. the proposed enterprise responsible person and quality management personnel ID card, academic or professional title certificate copies and biographical data;

6. the proposed enterprise organization and functional framework;

7. the proposed enterprise registered address, business address of the geographic location of the map, the layout of the layout of the function (indicating the area) and proof of ownership of the house, the lease Area) and proof of property rights, lease agreement, a copy of the housing lease record certificate;

8. Proposed enterprise warehouse location map, layout plan (indicating the name of the warehouse address, floor area, floor area, to be inspected area, qualified products area, non-qualified products area, shipping area, return area and its area) and proof of property rights, lease agreement, a copy of the housing lease record certificate;

< p>9. Proposed enterprise product quality management system documents;

10. Business facilities, equipment, table;

11. Proposed product registration certificate, a copy of the production license;

12. Where the application for the enterprise to declare the material, the processing staff is not the legal representative or person in charge of himself, the enterprise should submit the "power of attorney";

13. Declaration of the authenticity of the materials commitment.

Hope to help you, hope to adopt, thank you!