Hello, in fact, you only need to according to the "Food and Drug Administration on the issuance of medical equipment business chain key regulatory catalog and on-site inspection of the key content of the notice" this notice and its annex content one by one to the operation can already be. As long as you meet the requirements of your application will certainly be passed!
The following are some of the relevant attachments, which I hope will be helpful to you.
1. Check the legal qualifications:
(1) whether the products have obtained the medical device registration certificate, qualified documents;
(2) medical device business license or filing credentials, business license, the scope of business whether it covers the products operated;
(3) the supplier's medical device production (business) License or record certificate, business license, whether the scope of business covers the products operated;
(4) whether the authorization of the sales staff to meet the requirements.
2. Check the warehouse management:
(1) Warehouse facilities and equipment and maintenance records;
(2) Temperature and humidity daily monitoring records;
(3) Whether the storage state of the product is in line with the requirements of the instruction manual;
(4) Whether the product packaging is opened or damaged;
(5) The record of validity warning.
3. Check the quality of traceability:
(1) computer information management system can ensure that the operation of the product can be traced (Category III);
(2) suppliers with the goods with the same list;
(3) incoming inspection records;
(4) out of the warehouse to review the check records;
(5) the validity of the warning records. p>
(5) Sales records (wholesale);
(6) Records of disposal of returned products or defective products;
(7) Whether the contents of instructions and labels are in line with the relevant contents of the registered, whether there is incomplete labeling, unclear labeling of storage requirements, and whether the imported products are available in Chinese instruction manuals, Chinese labels.
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1. Check the legal qualifications:
(1) whether the products have obtained the medical device registration certificate, qualified documents;
(2) medical device business license, business license, business scope of the products covered by the operation;
(3) the supplier's medical device production (business) license, business license, business scope of the products covered by the operation;
(3) the medical device production (business) license, business license, business scope of the suppliers. business) license, business license, whether the scope of business covers the products being operated;
(4) whether the authorization letter of the salesperson meets the requirements.
2. Check the warehouse management:
(1) warehouse facilities and equipment and maintenance records;
(2) whether the storage state of the product is the same as the instructions;
(3) whether the product packaging is open or damaged;
(4) the expiration date of the warning records.
3. Check the quality of traceability:
(1) the computer information management system can ensure that the operation of the product can be traced;
(2) supplier accompanying goods with the same list;
(3) incoming inspection records;
(4) out of the warehouse to review the checking records;
4. Check the after-sales management:
(1) Whether equipped with medical related college degree or above, and through the production company or supplier training personnel;
(2) Purchase and sale agreement is clear quality responsibility and after-sales service responsibility.
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