Certificate of pre-approval of enterprise name issued by the administrative department for industry and commerce;
ID card, education background, copy of professional title certificate and resume of the enterprise quality administrator to be established;
The organization and functions of the enterprise to be established;
A copy of the geographical location map, floor plan (indicating the area) of the registered address and warehouse address of the proposed enterprise, and the house property certificate (or lease agreement);
Product quality management system documents and storage facilities and equipment catalogue of the proposed enterprise;
Business scope of the enterprise to be established.
There are quality management institutions or full-time quality management personnel suitable for the business scale and scope. Quality management personnel should have relevant professional or professional titles recognized by the state;
It has a relatively independent business place suitable for its business norms and business scope;
Having storage conditions suitable for business norms and business scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;
We should establish and improve the product quality management system, including purchasing, incoming inspection, warehousing, outbound review, quality tracking and reporting the time of poor quality;
It shall have the technical training and after-sales service ability suitable for the medical device products it deals in, or agree to provide technical support by a third party.
The requirements in different regions are slightly different. . . I hope it helps you. Ozda medical device consulting organization.