1, registered processing plant name
Registered processing plant needs to prepare a name, the name usually consists of "region + name + industry + limited processing plant".
2, submit processing plant registration information
Name review through, fill out the other materials to determine the registered address of the processing plant management information content, scope of business, to carry out the actual operation on the Internet, according to the _ Yung reminded to submit the submission!
3, apply for a business license
Industrial and commercial website to submit materials for review and approval, you will be able to obtain a license on site.
4, engraving and other matters
With the business license, to the Public Security Bureau designated seal engraving point for: processing plant seal, financial chapter, contract chapter, legal representative of the chapter, invoice chapter; to this point, a processing plant registration is complete.
5, in the bank to open a basic account
Opening a basic account requires a legal person to appear in person, with all the business license (original and duplicate), corporate seal, financial seal, official seal, the legal person's original identity card.
6, tax reports
In the full implementation of the business license, organization code certificate, tax registration certificate "three certificates in one" registration system reform, based on the integration of social insurance registration certificate and statistical registration certificate, to achieve "five certificates in one, one code", help improve China's business enterprises. This will help improve the basic data of the main body of enterprises in China, help improve the accuracy and credibility of economic statistics, and is an important measure to continue to deepen the reform of the business system, help consolidate and expand the achievements of the reform of the "three certificates in one" registration system, and help to improve the quality of the registration system from "three certificates in one" to "three certificates in one". From "three certificates in one" to "five certificates in one", reduce costs, save time, for entrepreneurs is to seize the market opportunity.
I, the domestic registration of Class II, Class III medical devices required documents
(a) the domestic application form for registration of medical devices;
(b) medical device manufacturer's qualifications, including the manufacturer's license, a copy of the business license, and the product should be applied for in the manufacturer's license within the scope of the approved production;
(c) the product's technical report : at least should include technical indicators or the main performance requirements for determining the basis of content;
(d) safety risk analysis report: in accordance with YY0316 "Medical Device Risk Analysis" standard requirements for the preparation. There should be energy hazards, biological hazards, environmental hazards, hazards related to the use of hazards and by the failure of function, poor maintenance and aging caused by the hazards of the five aspects of the analysis and the corresponding preventive measures;
(E) the applicable product standards and instructions: the use of national standards, industry standards as the applicable standards of the product should be submitted to the national standards adopted by the national standards, industry standards of the text; registration Product standards should be signed by the manufacturer. Manufacturers should provide the application of product compliance with national standards, industry standards, the statement that the manufacturer bears the responsibility for the quality of the product after the listing of the statement as well as the relevant product model, specifications of the division of the description;
(F) self-test report on product performance: self-test of the product performance of the project for the registration of the product standards for the factory testing program, there should be a principal inspector or the person responsible for the main inspection, the reviewer's signature. Implementation of national standards, industry standards, the manufacturer shall supplement the self-defined factory test items;
(VII) medical device testing organizations issued by the product registration test report: the need for clinical trials of medical devices, should be submitted to the clinical trial within six months before the start of the test report issued by the medical device testing organizations. Do not need to conduct clinical trials of medical devices, should be submitted to the registration acceptance within one year before the test report issued by the medical device testing organization. Implementation of the provisions of Article 11, Article 12, Article 13, Article 14 of these Measures, should provide the corresponding description of the document;
(viii) medical device clinical trial information;
(ix) medical device instructions;
(j) product production quality system assessment (certification) of the validity of the supporting documents -According to the requirements of different products, provide the appropriate quality system assessment report:
1, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department signed, within the validity period of the system assessment report;
2, medical device production quality management standard inspection report or medical device quality system certification;
3, the state has implemented the implementation of production rules, the implementation of rules submitted to the inspection and acceptance report;
(k) the submitted materials to the authenticity of the self-assurance statement: it should include a list of materials submitted, the production of enterprises to assume legal responsibility for the commitment.
Legal basis
"Regulations for the Supervision and Administration of Medical Devices"
Article XIII of the first class of medical devices to implement the management of product filing, the second and third class of medical devices to implement the management of product registration.
Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, the safety and effectiveness of the responsibility according to law.
Article XIV of the first class of medical device products for the record and apply for the second and third class of medical device product registration, the following information shall be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection reports;
(d) clinical evaluation information;
(e) Product instructions and labeling samples;
(F) and product development, production and quality management system documents;
(G) to prove that the product is safe, effective and other information required.
The product inspection report shall meet the requirements of the State Council drug supervision and management department, can be the applicant for registration of medical devices, the filer of the self-inspection report, or commissioned by a qualified medical device inspection agency issued the inspection report.
Conforms to the provisions of Article 24 of the Regulations exempt from clinical evaluation of the situation, may be exempt from submitting clinical evaluation information.
Applicants for registration of medical devices, the filer shall ensure that the information submitted is legal, true, accurate, complete and traceable.