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.
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 V 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 to develop...? Chapter II apply for a "medical device business license" conditions Article VI apply for a "medical device business license" should have the following conditions:
(a) with the scale and 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 (D) shall 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 adverse event reporting system;
(E) shall have the appropriate technical training and after-sales service capabilities of its medical device products, or agreed to provide technical support by a third party. Article 7 The application for "medical device business enterprise 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 should be based on these measures, combined with the actual situation in the jurisdiction, to develop medical device business inspection and acceptance standards, reported to the State Food and Drug Administration for the record. Article VIII of the "medical device business license" set out the scope of business should be in accordance with the provisions of the medical device classification directory 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 department or accept the entrusted municipal (food) drug supervision and management agencies responsible for accepting the "Medical Device Business License" application for issuance of certificates. Article 10 Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or accept the commission of the municipal level (food) drug supervision and management agencies should be in its administrative website or application acceptance place to publicize the application for "medical device business license" required conditions, procedures, deadlines, the need to submit all the materials directory and the application form model text. Article XI of the application for "medical device business license", the following information shall be submitted:
(a) "Medical Device Business License Application Form";
(b) industrial and commercial administration department issued by the business name pre-approval of documents;
(c) the proposed quality management personnel's identity card, a copy of proof of academic qualifications or professional titles and Personal resume;
(d) the proposed enterprise organization and functions;
(e) the proposed enterprise registered address, warehouse address of the geographic location map, floor plan (indicating the area), a copy of proof of ownership of the house (or lease agreement);
(f) the proposed enterprise product quality management system documents and storage facilities, equipment directory;
(vii) Proposed enterprise business scope. Article 12 The applicant shall apply to the proposed business location of 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 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" should be stamped with the acceptance of the special seal and indicate the date of acceptance.