Article 1 In order to strengthen the supervision and management of medical device business license, according to the "supervision and management of medical devices regulations", the development of these measures.
Second "Medical Device Business License" issuance, renewal, change and supervision and management of the application of these measures.
Article < /strong>Third management of the second and third class of medical devices should hold a "medical device business license", but in the circulation process through the routine management can ensure its safety, effectiveness of a few second class of medical devices can not apply for a "medical device business license". Do not need to apply for a "medical device business license" of the second class of medical devices by the State Food and Drug Administration to develop a product list.
Article 4 State Food and Drug Administration in charge of the supervision and management of the national "medical device business license".
Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration is responsible for the jurisdiction of the "medical device business license" of the issuance, renewal, change and supervision and management work.
Settings of municipal (food) drug supervision and management agencies or provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments set up directly by the county (food) drug supervision and management agencies are responsible for the jurisdiction of the "medical device business license" of the daily supervision and management work.
Article 5 State Food and Drug Administration to gradually implement the medical device quality management system. Medical device business quality management standard by the State Food and Drug Administration organization.
Chapter II Application for "Medical Device Business License" conditions
Article 6 Application for "Medical Device Business License" shall have the following conditions:
(a) with the scale of operation and the scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
(e) should have the appropriate technical training and after-sales service with its business medical device products, or agreed by the third party to provide technical support.
Article 7 Application for "Medical Device Business License" must pass the inspection and acceptance of the (food) drug supervision and management department.
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments shall, in accordance with these measures, combined with the actual situation in this jurisdiction, to develop medical device business enterprise inspection and acceptance standards, reported to the State Food and Drug Administration for the record.
Article 8 "Medical Device Business License" business scope should be specified in accordance with the medical device classification directory of the management category, class code name.
Chapter III Application for "Medical Device Business License" procedures
Article IX proposed business location of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management departments, or to accept the entrusted municipal (food) drug supervision and management agencies are responsible for accepting the "Medical Device Business License" of the application for issuance of licenses.
Article 10 provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal (food) drug supervision and management agencies shall be entrusted in its administrative website or application acceptance place to apply for a "medical device business license" required conditions, procedures, deadlines, need to submit all the materials directory and the application form model text.
Article 11 Application for "Medical Device Business License" shall be submitted as follows:
(a) "Medical Device Business License Application Form";
(b) the industrial and commercial administration department issued by the business name pre-approval of the documents;
(c) the proposed enterprise quality (C) the proposed enterprise quality management personnel identity card, a copy of proof of academic qualifications or titles 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), proof of ownership of housing (or lease agreement) copy;
(F) the proposed enterprise product quality management system documents and storage facilities, equipment catalog;
(vii) the proposed business scope of the enterprise.
Article 12 Applicants shall apply to the proposed business location of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management departments, or to accept the entrusted municipal (food) drug supervision and management agencies to submit the "medical device business license" application for issuance of licenses.
For the applicant's "medical device business license" licensing application, the province, autonomous region, municipality directly under the central government (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies should be dealt with in accordance with the following:
(a) the application does not fall within the purview of the department, it should be made immediately inadmissible Decision, issued a "Notice of Inadmissibility", and inform the applicant to the relevant departments;
(b) the application materials can be corrected on the spot there are errors, the applicant should be allowed to correct on the spot;
(c) the application materials are incomplete or do not comply with the statutory form, it should be on the spot or within five working days to the applicant to issue a "Notice of Supplementary Materials", a one-time notice of All the contents that need to be corrected. Late notification, from the date of receipt of the application materials shall be accepted;
(d) the application matters within the purview of the department, the application materials are complete, meet the statutory form, or the applicant in accordance with the requirements to submit all the corrections to the application materials, issued a "Notice of Acceptance". Notice of Acceptance" shall be stamped with the acceptance of the special seal and indicate the date of acceptance.
Article XIII provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies in accordance with the commissioned area based on the acceptance of medical device business inspection standards for on-site verification of the proposed business, and in accordance with this approach to the review of the application materials.
Article XIV provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department shall, within 30 working days from the date of acceptance to make a decision on whether to issue a "medical device business license". Considered to meet the requirements, shall make a decision to grant the issuance of "medical device business license", and within 10 days of the date of decision to the applicant issued "medical device business license". That does not meet the requirements, shall notify the applicant in writing, and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law.
Article 15 (food) 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 presentation and defense.
"Medical Device Business License" application directly involves the applicant and others with significant interests, (food) drug supervision and management department shall inform the applicant and interested parties the right to apply for a hearing in accordance with the law.
(Food) drug supervision and management department that "medical device business license" involves public **** interests, shall be announced to the community, and hold a hearing.
Article 16 provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department shall publish has been issued by the "medical device business license" of the relevant information, the public has the right to inquire.