On the medical device license application procedures in August 9, 2004 by the State Food and Drug Administration promulgated the "medical device business license management approach" Chapter III has clear, detailed provisions and instructions:
Medical device license application procedures: Submit an application.
The proposed business location of the provincial, autonomous regions, municipalities directly under the Central Food and Drug Administration or accept the entrusted municipal food and drug supervision and management agencies are responsible for accepting applications for the issuance of medical device business license.
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration or accept the entrusted municipal food and drug supervision and management agencies should be in its administrative website or application acceptance place to publicize the application for the "medical device business license" required conditions, procedures, deadlines, the need to submit all the materials directory and the application form model text.
Application for a medical device license, you need to submit those materials:
(a) "Medical Device Business License Application Form";
(b) industrial and commercial administration issued by the business name pre-approval of documents;
(c) the proposed enterprise quality management personnel's identity card, a copy of proof of qualifications or professional title and personal resume
(d) the proposed enterprise organization and functions;
(e) the proposed enterprise registered address, warehouse address of the geographic location of the map, floor plan (indicating the area), building ownership certificates
Min (or lease agreement) copies;
(f) the proposed enterprise product quality management system documents and storage facilities, equipment catalog;
(G) the proposed business scope of the enterprise.
Article XII of the applicant shall be to the proposed business location of the province, autonomous region, municipality directly under the Central Food and Drug Administration or accept the entrusted municipal food and drug supervision and management agencies to make "medical device business license" application for licensing. For the applicant to apply for a medical device license application, the province, autonomous region, municipality directly under the central food and drug supervision and management department or accept the entrusted municipal food and drug supervision and management agencies shall be dealt with in accordance with the following:
(a) the application does not belong to the terms of reference of the department, shall immediately make a decision of inadmissibility, issued to the No
Notice of Acceptance", and inform the applicant to apply to the relevant departments;
(ii) application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
(iii) application materials are incomplete or do not comply with the statutory form, should be issued on the spot or within five working days to the applicant "Notice of Rectification", a one-time notification of need to make corrections of all contents. All the contents. Late notification, from the date of receipt of the application materials shall be accepted;
(d) the application falls within the purview of the department, the application materials are complete, meet the statutory form, or the applicant in accordance with
requests to submit all the corrections in the application materials, issued a "Notice of Acceptance". Acceptance Notice" should be stamped with the acceptance of the special seal and indicate the date of acceptance.
Medical equipment business license application process two: on-site review and data review
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration or accept the entrusted municipal (food
products) drug supervision and management agencies in accordance with the acceptance of medical device business inspection standards for on-site verification of the proposed enterprise, and according to the methods of the application data for the Review.
Medical equipment business license application process three: inform the results of the review
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall, within 30 working days from the date of acceptance of the decision on whether to issue a medical equipment business license. Considered to meet the requirements, should be made to grant the issuance of "medical device business license" decision, and within 10 days of the date of decision to the applicant issued a medical device license. That does not meet the requirements, shall notify the applicant in writing, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration or administrative litigation according to law.
Food and drug supervision and management department of the applicant's application for review, shall publicize the approval process and approval results. The applicant and interested parties may submit written comments on matters directly related to their vital interests for statement and defense. Medical Device Business License" application directly involves the applicant and others with significant interests, the food and drug supervision and management department shall inform the applicant and the interested party to enjoy the right to apply for a hearing in accordance with the law. Food and drug supervision and management department that the medical device business license involves public **** interests, should be announced to the community, and hold a hearing.
Provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration shall publish information about the medical device business license has been issued, the public has the right to inquire.
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Aojida only focuses on the medical device field.