Article IX for the applicant to apply for a license for the operation of Class III medical devices, the municipal food and drug supervision and management departments should be based on the following circumstances were dealt with:
(a) the application belongs to the scope of its competence, the application information is complete, in accordance with the statutory form, the application should be accepted;
(b) the application information is not complete or does not meet the statutory form, the applicant shall be informed on the spot or within five working days of all the contents of the need to make corrections, and if not informed after the deadline, the application shall be accepted from the date of receipt of the application information;
(c) the application information can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
(d) the application does not fall within the purview of the department, it should be immediately make a decision of inadmissibility, and inform the applicant to apply to the relevant administrative departments.
Settlement of municipal food and drug supervision and management departments to accept or reject the application for a medical device license, shall issue a notice of acceptance or inadmissibility.
Article 10 municipal food and drug supervision and management department shall accept the date of 30 working days from the date of application for review, and in accordance with the requirements of the quality management standard for the operation of medical devices to carry out on-site verification. The need for rectification, rectification time is not counted in the audit time limit.
Meet the prescribed conditions, according to law to make a written decision to grant permission, and within 10 working days to the "medical device license"; does not meet the prescribed conditions, make a written decision not to permit, and explain the reasons.