Legal analysis: the application for "medical device business license" should also have the following conditions
(a) with the scale and scope of operation of the quality management organization or college education above the quality management personnel two. Quality management personnel should have a nationally recognized professional qualifications or titles;
(b) with the scale and scope of operation of relatively independent premises;
(c) with the scale and scope of operation of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of medical equipment products;
(d) 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 to provide technical support by a third party.
Legal basis: "People's Republic of China *** and the State Administrative License Law" Article 5 The setting and implementation of administrative licenses shall follow the principles of openness, fairness, impartiality and non-discrimination.
Provisions relating to administrative licenses shall be made public; if they have not been made public, they shall not be used as the basis for the implementation of administrative licenses. The implementation and results of administrative licenses shall be made public, except where state secrets, commercial secrets or personal privacy are involved. Without the consent of the applicant, the administrative organ and its staff, personnel involved in expert evaluation, etc. shall not disclose the applicant to submit trade secrets, undisclosed information or confidential business information, except as otherwise provided by law or involving national security, major social public **** interests; administrative organs in accordance with the law to disclose the applicant of the foregoing information, the applicant shall be allowed to raise objections within a reasonable period of time.
In compliance with the legal conditions and standards, the applicant has an equal right to obtain administrative licenses in accordance with the law, the administrative organ shall not discriminate against anyone.