One, the license content: two, three types of medical equipment manufacturer qualification recognition
Two, set and implementation of licensing laws and regulations based on:
1, "Supervision and Administration of Medical Devices Regulations"
2, the State Food and Drug Administration, "Supervision and Administration of Medical Device Manufacturing Measures"
Three, the applicant needs to submit the materials of the directory ( In duplicate):
1, "Medical Device Manufacturer License Application Form.
2, the legal representative, the person in charge of the enterprise's basic information and proof of qualifications.
Including ID card, proof of education, proof of title, the original and copies of appointment documents, work resume.
3, a copy of the notice of pre-approval of the name of the proposed enterprise or business license issued by the administration for industry and commerce.
4, production site supporting documents and floor plan.
Property certificate or a copy of the lease agreement and the property certificate of the leased party; office, production, inspection, warehousing and other places of the floor plan, indicating the corresponding area.
5, the enterprise's production, technology, quality department responsible for the resume, education and title certificate of the original and a copy; relevant professional and technical personnel, skilled workers registration form, a copy of the certificate, and indicate the department and position; the proportion of senior, middle and junior technicians table;
Internal auditor certificate and inspector training certificate of the original and a copy.
6, the scope of products to be produced, varieties and related product profiles.
Product profiles include at least a description of the product's structural composition, principles, intended use and product standards.
7, the main production equipment and inspection instruments list.
8, production quality management standardized document catalog.
Mainly procurement, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, user feedback, adverse events and quality accident reporting system and other documents. Enterprise organization chart.
9, the process flow diagram of the proposed product, and indicate the main control items and control points.
Description of equipment, personnel and process parameter control for critical and special processes.
10, the proposed production of sterile medical devices, need to provide a clean room qualified test report.
Conforms to the management of sterile medical devices YY0033 standards of the relevant state departments recognized testing organizations issued within one year of the qualified test report,
11, the application material authenticity of the self-assurance statement.
List the catalog of declaration materials, and materials to make a commitment to bear legal responsibility for any false, stamped or signed by the legal representative.
Four, the requirements for the declaration of information:
1, the first page of the declaration of information for the declaration of information items in the catalog, the catalog of items in the order of the declaration of information, the whole set of information should be bound in a book. Where the submission of materials for copies should be stamped or signed by the applicant.
2, the declaration of information in duplicate, the declaration of information should be printed on A4-size paper, the content is complete, clear, and shall not be altered, the documents issued by the government and other agencies to provide the original size.
3. The copies of the declaration information should be clear.
4. After the acceptance of the declaration information, the enterprises shall not supplement the application by themselves.
5, the medical device manufacturer license application form medical device manufacturer license application form should be filled out in accordance with the requirements of filling instructions.
6, the specific material review requirements can be seen in the "Medical Device Manufacturer License" approval of the operating norms
V. Licensing Procedures:
(a) Acceptance
The applicant to the administrative acceptance center to apply in accordance with the directory listed in Article V of these instructions to submit applications, acceptance of the center in accordance with the requirements of the staff of the form of review of the application materials. Application matters are not required by law to obtain an administrative license, the applicant shall be immediately informed of inadmissibility; application matters do not fall within the purview of the administrative organ, it shall immediately make a decision of inadmissibility, and inform the applicant to apply to the relevant administrative organ; application materials can be corrected on the spot there are errors, the applicant shall be allowed to correct the application on the spot; application materials are incomplete or do not comply with the statutory form, it shall be On the spot or within five days to inform the applicant of all the contents of the need to make corrections, overdue notification, from the date of receipt of the application materials shall be accepted; the application falls within the purview of the administrative organ, the application materials are complete, in line with the statutory form, or the applicant in accordance with the requirements of the administrative organ to submit all the corrective application materials, the application should be filled in the receipt of materials, within five days to make a decision on the acceptance of the application.
(B) review
Administrative Acceptance Center acceptance, the application materials will be sent to the Medical Devices Division of the manufacturer license examiners for material review and on-site review.
(C) licensing decision
Review authority within 30 days to make a decision to license or not license, not approved, shall state the reasons.
(D) delivery
From the date of the administrative licensing decision shall be made within 10 days of the Internet public notice to the applicant.
VI. Commitment time limit: from the date of acceptance, within 30 days to make a decision on administrative licensing.
VII, the implementing agency:
Implementing Agency: Fujian Provincial Food and Drug Administration
Acceptance: Fujian Food and Drug Administration, Administrative Acceptance Center
VIII, the matter of change:
"Medical Device Manufacturer License" listed in the contents of the change, the licensee shall apply for a change in procedures. (See the "Medical Device Manufacturer License" approval of the operating instructions)
Nine, the license is valid and renewal:
"Medical Device Manufacturer License" is valid for five years. The licensee should be in the "Medical Device Manufacturer License" expires within six months before the application for renewal.
Ten, consultation and complaint institutions:
Consultation: Fujian Provincial Food and Drug Administration Medical Devices or log Fujian Provincial Food and Drug Administration website
Complaints: Fujian Provincial Food and Drug Administration Supervision Office Note: The working period of this note is calculated on working days, excluding statutory holidays