X-ray film machine, ultrasound, microscope, biochemistry instrument belongs to Class II.
Class II refers to medical devices whose safety and effectiveness should be controlled.
According to the "supervision and management of medical devices regulations" Chapter IV, Article 30: engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of food and drug supervision and management department for the record and submit it to comply with the conditions of Article 29 of these regulations.
Article 29 to engage in the operation of medical devices, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
Expanded Information:
The application process for Class II medical devices:
1, the application does not fall within the purview of the department, it should be made immediately Inadmissible decision, and inform the applicant to the relevant administrative organs;?
2, the application materials there can be corrected on the spot error, the applicant should be allowed to correct on the spot;?
3, the application materials are incomplete or do not meet the formal review requirements, shall be issued on the spot or within five working days to the applicant "Notice of Corrective Material", a one-time notification to the applicant needs to make corrections to all the contents of the application, the late notification, from the date of receipt of the application materials shall be deemed to be accepted;?
4. If the application materials are complete and meet the formal examination requirements, or if the applicant submits all the supplementary application materials as required, the application shall be accepted.
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