Medical supplies belong to a medical device, regular medical supplies to have qualified documents, generally need to have three documents, respectively, medical device manufacturer license, medical device license, quasi medical device registration certificate:
1, medical device production license
This is a medical device manufacturer Must hold the document, issued by the local Drug Administration audit, the production of medical supplies and other devices must have this document.
2, medical device license
This is also a medical supplies company must have the documents, different classes of medical supplies for the documents are different, the opening of the second class of medical equipment business enterprises, should be to the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for the record; the opening of the third class of medical equipment business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for examination and approval, and should be the first time. People's government drug supervision and management department for examination and approval, and issued "medical equipment business license.
3, quasi medical device registration certificate
This refers to the legal procedures, the proposed market sales, the use of medical consumables for systematic evaluation of safety, effectiveness, in order to decide whether or not to agree with the sale, use, and issue certificates. It is divided into domestic medical device registration and overseas medical device registration, overseas medical devices, whether Class I, Class II, Class III to the State Food and Drug Administration in Beijing for: domestic Class I, Class II medical devices in the local provincial or municipal food and drug administration for, Class III to the State Food and Drug Administration for. The medical device registration certificate is the legal identity card of medical consumable products.
Two, medical supplies qualification documents audit points
Audit qualification documents is the first step in the medical supplies can be used in hospitals, qualification documents qualified, the relevant products can be purchased and used, the general medical supplies documents audit points are:
1, complete audit
Hospitals use thousands of types of medical supplies, corresponding to qualification documents are also very many. Documentation information is also very much, the general audit, the qualification of cell phone documents should be classified, divided into the supplier qualification documents, manufacturers or domestic general agent enterprise documents, product documents and authorization documents, and then divided into categories of audit.
2, the validity of the audit
Design of medical supplies of many qualification documents are time-sensitive, need to be updated periodically. Whether the qualification documents are within the validity period will affect whether the medical consumables can be used legally and safely, so it is particularly necessary to audit the qualification documents are within the validity period.
3, the scope of business and authorization scope audit
General medical supplies company's business license has a business scope, the audit needs to check whether the medical supplies provided in its business scope; in addition, in order to ensure that the source of the product is legitimate and reliable, to audit the agency authorization of the authorized product line and agency area covers the relevant products and use of hospitals.
4, medical device registration certificate audit
Mainly against the medical consumables physical product identification information and registration certificate information, to see whether the information is consistent, and to ensure that medical consumables in the manufacturer's production of product registration form
5, authenticity audit
In order to ensure that the credentials provided by the source of a reliable, all qualification documents to be stamped The official seal of the supplier, the current can also be used to approve the qualification documents of the competent authorities of the database, in the audit of the documents, you can log on the official website of the government authorities issued by the Office of the Securities and Futures Commission to query, in order to approve the authenticity of the qualification documents.