The first class of medical devices within the territory of the municipal (food) drug supervision and management agencies to review and approve the issuance of medical device registration certificate. Third, the approval conditions and standards Application for registration of medical devices, the applicant to the Municipal Food and Drug Administration to apply, and should fill out the application form for registration of medical devices, in accordance with the appropriate requirements for the submission of application materials. Application materials should be used in Chinese; according to foreign language data translated application materials, should also provide the original text. The applicant to submit the medical device specification should be consistent with the "medical device instructions, labels and packaging marking regulations. The applicant shall be responsible for the authenticity of all the contents of its application materials. Fourth, the required materials (a) "Domestic Medical Device Registration Application Form"
The applicant company to fill in the submission of the "Domestic Medical Device Registration Application Form" should be signed by the legal representative and stamped with the official seal, the items filled out should be complete and accurate, fill in the content should meet the following requirements:
1. "Name of the manufacturer", "Registered address" and the "industrial and commercial business license" is the same;
2, "product name", "specifications" and the submitted product standards, test reports and so on. Application materials used in the name, specifications and models consistent. (B) medical device manufacturer qualification certificate
Qualification certificate includes "Class I medical device manufacturer registration form" copy and "business license" copy.
1, the application for registration (re-registration) of the product should be in the "Class I Medical Device Manufacturer Registration Form" within the approved scope of production;
2, "industrial and commercial business license" within the validity period. (C) the applicable product standards and instructions
The product standards submitted by the applicant company can be national standards, industry standards or registered product standard text.
1, the use of national standards, industry standards as product standards, should be submitted to the national standards or industry standards adopted by the effective text and the adoption of standardized instructions;
2, the use of registered product standards as product standards, should be submitted to the official text of the registered product standards and their preparation instructions. Manufacturers should provide the application for products in line with national standards, industry standards, the statement that the manufacturer assumes responsibility for the quality of the products listed on the statement as well as the relevant product model, specification division. (D) product full performance test report
Product full performance test report should include the following:
1, product name, specifications, product number or batch number, date of production, number of samples, the sampling base;
2, test basis, test items, standard requirements, test results, results of the verdict, the inspector, the auditor's signature or seal, test Date, etc.;
3, such as commissioned tests, should be provided by the commissioned testing organization issued a test report and commissioned test agreement. (E) the production of products and quality management capabilities of existing resource conditions (including testing methods) of the description
Enterprise production of products and quality management capabilities of existing resource conditions (including testing methods) of the description should include the following:
1, the application of the enterprise's existing resources (human resources, infrastructure, working environment, etc.) conditions, management capacity, production capacity, testing methods and capabilities of the description;
3, if the commissioned test should provide the commissioned test report and the commissioned test agreement. Ability to explain;
2, provide a list of production equipment, testing instruments and product testing of measuring instruments required for valid verification certificate (copy). (F) medical device instructions
Medical device instructions should include at least the following:
1, product name, model number, specifications;
2, the name of the manufacturer, registered address, manufacturing address, contact information;
3, "Medical Device Manufacturer License" No., the number of the certificate of registration of medical devices (the contents of the declaration of blank) , product standard number;
4, product performance, main structure, scope of application. (G) the submitted material authenticity of the self-assurance statement Authenticity of the self-assurance statement should be signed by the legal representative or person in charge of the applicant enterprise and stamped with the official seal of the enterprise, and include the following:
1, a list of the submitted application materials;
2, the commitment of the manufacturer to assume the corresponding legal responsibility. (viii) Format Requirements of Application Materials
1, the same item in the application materials should be filled out consistently;
2, the application materials should be printed on A4-size paper, and the documents issued by the government and other organizations should be provided in the original size;
3, the application materials should be clear and neat, and each copy of the application materials should be stamped with the official seal of the enterprise and be bound into a book according to the order of the catalog of the application materials. The application materials should be clear and neat. (A) the applicant to the Municipal Food and Drug Administration Medical Devices Section to apply, and submit the application materials as required. (B) Medical Device Section received an application, should be based on the following circumstances were dealt with: 1, the application does not belong to the department's terms of reference, it should be made immediately inadmissible decisions, issued a "notice of inadmissibility", and inform the parties to the relevant administrative organs. 2, the application materials are incomplete or do not meet the formal review requirements, shall be issued on the spot or within five working days to the applicant "Notice of Corrective Material", a one-time notification of the applicant needs to make corrections to all the contents of the application materials are accepted from the date of receipt of the application materials; 3, the application materials are complete, meet the formal review requirements, or the applicant in accordance with the requirements to submit all the supplementary application materials, shall be accepted, issued a "Notice of Acceptance". Be accepted, issued a "Notice of Acceptance. Sixth, the review and determination (a) Medical Devices Section accepts the application, within 30 working days of the application materials for substantive review, after review does not meet the requirements, make a written decision not to register, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law. After reviewing the provisions of the report to the Secretary for approval, signature, and a written decision to grant registration. (B) from the date of written approval made within 10 working days from the date of issuance of the certificate of registration of medical devices. (C) has been approved for registration and issued a certificate of registration, reported to the provincial bureau for the record. Seven, the public announcement of the original text of this system and the application materials model text in Shuangyashan Food and Drug Administration website for long-term publication, you can log on to the following municipal bureau Web site query (/), the results of administrative approvals in the site more than 7 working days. Eight, the processing time limit Since the receipt of the application for acceptance, within 30 working days of the application materials for substantive review, the review meets the requirements, to make a written decision to grant registration. Within 10 working days to issue a certificate of registration of medical devices. Nine, supervision and inspection (a) within the section of the implementation of this system for regular self-examination and self-examination; (b) the City Council has the function of supervision and inspection of the implementation of this system for regular supervision and inspection, not less than once every six months; (c) through the form of open publicity to accept social supervision; (d) accept the National People's Congress, the Chinese People's Political Consultative Conference and other aspects of the supervision and inspection; X. Accountability (a) the section below (including the section level) The responsible person violates the provisions of this system, the circumstances are less serious, the internal disciplinary inspection team ordered to correct the situation, a cautionary talk or notification of criticism; the circumstances are more serious, according to the law to give the appropriate sanctions, and transfer out of the existing work position, may not be engaged in the nature of the post within one year and the same or similar work. (ii) If the responsible person concerned at the division level violates the provisions of this system under less serious circumstances, the Municipal Commission for Discipline Inspection shall order correction, conduct a cautionary talk or notify and criticize; if the circumstances are serious, the person concerned shall be given appropriate punishment according to law, and shall be transferred out of the existing work position, and shall not be allowed to engage in work of the same or similar nature as that position within one year. (C) the above responsible person violates the provisions of this system, constitutes a crime, transferred to the judicial organs. (A), the application for the opening of the following information to be provided:
1, the opening of a pharmacy application (Form 1);
2, preparation for the establishment of a retail drug application form (Form 2);
3, the Commerce and Industry Bureau of the name pre-approval of the original and a copy of the notice.
4, legal representative of the pharmacy, the person in charge of the enterprise (Form 3), the person in charge of quality resume (Form 4);
5, pharmacy legal representative, the person in charge of the enterprise, the person in charge of quality ID card copy
6, pharmacy legal representative, the person in charge of the enterprise, the person in charge of quality of the original and copy of the certificate of academic qualifications;
7, the person in charge of quality of the pharmacy, Quality management personnel title certificates, registration certificates, originals and copies;
8, the original and copies of proof of the proposed use of housing (real estate certificates and rental agreements);
9, housing geographic location map and business premises, warehouse floor plans;
10, pharmacy business person in charge, the person in charge of quality no part-time proof;
11, pharmacy legal representative, Business person in charge, the person in charge of quality without violation of the certificate;
12, the legal representative of the quality of the person in charge of the employment contract or letter of appointment.