Application for a "medical device business license" should also have the following conditions:
(a) with the scale and scope of operation of the quality management institutions 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 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) should have its business with the medical device products appropriate technical training and after-sales service capabilities, or agreed to provide technical support by a third party.
Two, apply for a "medical device business license" procedures:
(a), the applicant should be 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 a "medical device business license" application for issuance of licenses.
Application for "Medical Device Business License" should be submitted as follows:
1 "Medical Device Business License Application Form";
2 industrial and commercial administration issued by the business name pre-approval of documents;
3 proposed enterprise quality management personnel identity card, academic or professional title certificates and copies of the resume; < /p>
4 proposed enterprise quality management personnel.
4 proposed enterprise organization and function;
5 proposed enterprise registered address, warehouse address of the geographic location map, floor plan (indicating the area), proof of property rights (or lease agreement) copy;
6 proposed enterprise product quality management system documents and storage facilities, equipment directory;
7 proposed business scope.
(2), for the applicant to put forward the "medical device business license" licensing application, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies should be entrusted to deal with the following situations:
1 application does not fall within the purview of the department, it should be made instantly inadmissible Acceptance of the decision, issued a "Notice of Inadmissibility", and inform the applicant to apply to the relevant departments;
2 application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
3 application materials are incomplete or do not meet 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;
4 application matters within the purview of the department, the application materials are complete, in accordance with the statutory form, or the applicant in accordance with the requirements to submit all the corrective application materials, issued a "Notice of Acceptance". Notice of Acceptance" shall be stamped with a special seal of acceptance and the date of acceptance.
(c), 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 medical device business inspection and acceptance criteria for the proposed business on-site verification, and in accordance with this approach to the review of the application materials.
(d), provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments should be accepted within 30 working days from the date of issuance of "medical device business license" decision. 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 the decision to the applicant to issue "medical device business license". That does not meet the requirements, the applicant shall be notified in writing, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration according to law or the right to file an administrative lawsuit.