Registration process is as follows:
1, go to the business sector to apply for the "name pre-approval notice" to determine your store name.
2, to the local Food and Drug Administration to consult how to apply for "Medical Device Business License"
3, get the "Medical Device Business License", to the business sector for the individual business license, the materials required are: the original ID card and photocopies of the store site documents (property or land certificate copies), the original lease contract and copies of the A photo of the document, the original and copy of the Medical Device Business License. As long as the materials are complete and meet the requirements of the business sector, then generally a week to get a business license.
4, obtain a business license within 30 days, to the local local tax bureau, the National Tax Bureau for the "tax registration certificate", the cost is more than ten dollars of the cost, basically instant for the instant tax registration certificate.
5, the organization code certificate, according to the actual need to decide whether to go to the local county-level quality and technical supervision authority for.
The second class of medical devices registration materials:
1.application form.
2. Supporting documents: 2.1 a copy of the business license of the enterprise. 2.2 a copy of the organization code certificate.
3. List of basic requirements for the safety and effectiveness of medical devices.
4. Overview information.
5. Research information.
6. Manufacturing information: 6.1 Description of product manufacturing process information. 6.2 Production site.
7. Clinical evaluation information.
8. Product risk analysis information.
9. Product technical requirements.
10. Product registration and inspection reports: 10.1 registration and inspection reports. 10.2 pre-evaluation comments.
11. Instructions and labeling samples.
12. Declaration of Conformity.
13. Medical device registration quality management system verification submitted information or completed assessment report (rules acceptance report).
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