The second class of medical sales online filing process?
The online filing process of Class II medical devices:
Application for Class II medical device business record should be submitted to the information:
1, business license;
2, legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the person in charge of the certificate, certificate of qualifications or titles;
3, organizational structure and departmental setup instructions;
4, business scope, business mode description;
5, business premises, warehouse address of the geographic location map, floor plan, documents proving property rights of housing or lease agreement; (with documents proving property rights of housing)
6, business facilities, equipment directory;
7, business quality management system, work procedures and other documents directory;
8, to encourage the The use of computer information management system;
9, proof of authorization of the operator;
10, signed and stamped scanned application form;
11, other supporting materials.
Medical device health care products record management?
The state regulation of medical devices and health products is very strict. Medical devices and health care products, must go to the provincial market supervision authority for the record.
And Zhejiang Province since September 1, 2020 onwards, no longer handle foreign drugs, medical devices, health food advertising to Zhejiang Province before the release of the record.
Medical device network record certificate how to query?
In the State Drug Administration website query, open the "medical device" section: (/ylqx/index.html)
Tap the link to enter the site, you will see the page on the right side of a medical device query portal. Don't be in a hurry to click on which to enter, you should first determine their own query of medical equipment products are imported or domestic, if domestic on the point of "domestic devices", if imported, click on the "imported devices". The first thing you need to do is to check out the information on the record.
Taobao store business condoms should be how to handle the second class of medical devices for the record?
The second class of medical devices business filing
A, the conditions of the record engaged in the operation of medical devices, should have the following conditions:
1, the enterprise, the enterprise's legal representative or the person in charge of the enterprise, the person in charge of quality management does not have the "supervision and management of medical devices regulations" Article 63, Article 64, Article 65 of the circumstances;
2 With the scale and scope of business with the quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles;
3, with the scale and scope of business with the business premises, medical device business, storage shall not be set up in residential premises and other unsuitable for business premises;
4, With the business scale and scope of storage conditions, all entrusted to the third-party logistics enterprises of medical devices can not set up storage;
5, with the operation of medical equipment quality management system;
6, with its operation of medical equipment products appropriate professional guidance, technical training and after-sales service capabilities, or agreed by the third party Provide technical support;
7, engaged in the third class of medical devices business enterprises should be established with the scale of operation of the computer information management system.
8, the specific implementation of standards in accordance with the "Henan Province, medical device business on-site inspection and acceptance criteria" (Yu Food and Drug Administration, No. 24)
Two, the record procedure
1, the enterprise to submit the record materials
2, review the materials. The integrity of the filing materials for verification, the filing materials meet the prescribed conditions to be filed. For the record, the materials are incomplete or do not meet the prescribed form, should be informed of all the materials need to be corrected. Not for the record, the applicant should be informed on the spot and explain the reasons.
3, the Director of the review
4, the director in charge of signing approval
5, the issuance of filing vouchers
6, the online publicity
three, the submission of materials
1. Class II medical device business filing form;
2. Enterprise business license and medical device license (if any) copy;
4. Enterprise organization and departmental setup description;
5. Enterprise business address, warehouse address of the geographic location of the map, the floor plan (indicating the actual use of the area), the documents of property rights of the house and the lease agreement (with the document certifying the property rights of the house) a copy of;
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6. Directory of business facilities and equipment;
7. Directory of business quality management system, work procedures and other documents;
8. Proof of authorization by the operator;
9. Other supporting materials. The filing materials should be complete, clear, printed and bound on A4 paper with a table of contents, and copies stamped with the official seal and submitted together with the electronic version.
Four, the change of the record voucher
"Medical Device Business Record Voucher" in the enterprise name, legal representative, corporate officer, quality officer, business scope of business address, warehouse address and other filing changes should be re-applied for the record, and return the original "Medical Device Business Record Voucher".
Five, the record certificate of replacement
Medical equipment business enterprises lost "medical equipment business record certificate" should be immediately to the municipal food and drug supervision and management department report, and in the designated media to publish a statement of loss. After 1 month from the date of publication of the statement of loss, within 10 working days of receipt of the application for replacement of medical equipment business enterprises to reissue the "medical equipment business record certificate".
Small program on the sale of medical devices, WeChat can provide "medical equipment network trading services third-party platform filing certificate"?
WeChat is not the backend of a small program, it's just a medium. There is often more than one third-party platform behind a small program. Currently the medical device network sales management approach to the filing of small programs has no countermeasures.