1, check the name of the registered processing plant.
A registered processing factory needs to prepare a name, which usually consists of "region+brand name+industry+limited processing factory".
2. Submit the registration information of the processing plant.
After the name is approved, fill in other materials to determine the information content and business scope of the registered address management of the processing plant, and do the actual operation on the Internet and submit it according to the reminder!
3. Apply for a business license
After the materials submitted by the industrial and commercial website have passed the examination, you can get the certificate on the spot.
4. Sculpture and other matters
Go to the engraving point designated by the Public Security Bureau with the business license: official seal, financial seal, contract seal, legal representative seal and invoice seal of the processing factory; So far, a processing factory has been registered.
5. Open a basic account in the bank.
The opening of basic account requires the legal person to be present in person, with the business license (original and copy), legal person seal, financial seal and official seal, and the original legal person ID card.
6. Tax Report
On the basis of fully implementing the "three-in-one" registration system reform of industrial and commercial business license, organization code certificate and tax registration certificate, integrating social insurance registration certificate and statistical registration certificate to realize "five-in-one, one photo and one yard" is helpful to improve the basic data of Chinese enterprises and improve the accuracy and credibility of economic statistical data. It is an important measure to continue to deepen the reform of commercial system and consolidate and expand the "three-in-one" registration system.
Documents required for domestic registration of Class II and Class III medical devices
(1) Application form for registration of domestic medical devices;
(2) The Qualification Certificate of Medical Device Manufacturing Enterprise includes a copy of the license and business license of the manufacturing enterprise, and the products applied for shall be within the production range approved by the license of the manufacturing enterprise;
(3) Product technical report: It should at least include technical indicators or the basis for determining main performance requirements. ;
(4) Safety risk analysis report: prepared according to the requirements of YY03 16 Risk Analysis of Medical Devices. There should be an analysis of energy hazards, biological hazards, environmental hazards, related use hazards and hazards caused by functional failure, poor maintenance and aging, as well as corresponding preventive measures;
(5) Applicable product standards and descriptions: if national standards and trade standards are adopted as applicable standards for products, the texts of the adopted national standards and trade standards shall be submitted; The registered product standard shall be signed and sealed by the production enterprise. The production enterprise shall provide a statement that the product applied for conforms to the national standards and industry standards, a statement that the production enterprise bears the quality responsibility after the product goes on the market, and a description of the division of product models and specifications;
(6) Product performance self-inspection report: The product performance self-inspection items are the ex-factory inspection items specified in the registered product standards, and shall be signed by the chief inspector or the chief inspector and the auditor. Where national standards and industry standards are implemented, the production enterprise shall supplement the customized ex-factory inspection items;
(7) Product registration test report issued by the medical device testing institution: for medical devices that need clinical trials, the test report issued by the medical device testing institution within six months before the start of clinical trials shall be submitted. For medical devices that do not need clinical trials, the test report issued by the medical device testing institution within 1 year before registration acceptance shall be submitted. Where the provisions of Articles 11, 12, 13 and 14 of these Measures are implemented, the corresponding explanatory documents shall be provided;
(eight) clinical trial data of medical devices;
(9) Instructions for medical devices;
(10) Effective certification documents for product quality system review (certification)-Provide corresponding quality system review reports according to the requirements of different products:
1, the system review report signed by the (food) drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government within the validity period;
2, medical device production quality management standard inspection report or medical device quality system certification;
3, the state has implemented the detailed rules for the implementation of production, submit the inspection and acceptance report of the detailed rules for the implementation;
(11) Self-assurance statement on the authenticity of the submitted materials: it shall include the list of submitted materials and the commitment of the production enterprise to bear legal responsibilities.
legal ground
Regulations on the supervision and administration of medical devices
Thirteenth class I medical devices shall be subject to product filing management, and class II and III medical devices shall be subject to product registration management.
Medical device registrants and filers should strengthen the quality management of medical devices in the whole life cycle, and be responsible for the safety and effectiveness of the whole process of research and development, production, management and use of medical devices according to law.
Article 14 The following materials shall be submitted when applying for the filing of Class I medical device products and for the registration of Class II and Class III medical device products:
(a) product risk analysis data;
(2) product technical requirements;
(3) product inspection report;
(4) Clinical evaluation data;
(five) product specifications and sample labels;
(6) Quality management system documents related to product development and production;
(seven) other information required to prove the safety and effectiveness of the product.
The product inspection report shall meet the requirements of the drug supervision and administration department of the State Council, which may be the self-inspection report of the applicant and the filer of medical device registration, or the inspection report issued by a qualified medical device inspection institution.
In accordance with the provisions of Article 24 of these regulations, those who are exempted from clinical evaluation may be exempted from submitting clinical evaluation data.
Applicants and filers of medical device registration shall ensure that the materials submitted are legal, true, accurate, complete and traceable.