I. Class II medical devices include X-ray film machine, ultrasound, microscope, biochemical instrumentation and other medical devices that need to control the safety and effectiveness.
Second, 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 the municipal food and drug supervision and management department for the record and submit it to comply with the conditions of the provisions of Article 29 of these regulations.
Article 29 provides that: engaged 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.
Extended information:
Retail Class II medical device application process:
1, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department receives the application, should be based on the following circumstances, respectively, to make a deal:
(1) application matters in accordance with the law, the application should be made in accordance with the law. p>(1) the application does not belong to the department's terms of reference, shall immediately make a decision of inadmissibility, and inform the applicant to the relevant administrative organs;?
(2) application materials there are errors that can be corrected on the spot, the applicant should be allowed to correct on the spot;?
(3) If the application materials are incomplete or do not meet the formal examination requirements, the applicant shall be issued a Notice of Corrective Material on the spot or within five working days, informing the applicant of all the contents that need to be corrected in one go, and in case of any delay, the application shall be deemed to have been accepted as of the date of receipt of the application materials;?
(4) If the application materials are complete and meet the requirements for formal examination, or if the applicant submits all the supplementary application materials in accordance with the requirements, the application shall be accepted;?
2, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to accept or not accept the application for medical device manufacturers to start, should be issued with the department's special seal and date of acceptance of the "Notice of Acceptance" or "Notice of Inadmissibility".
3, the review meets the requirements, to make a written decision to grant a license, and within 10 working days to send "medical device manufacturer license. After review does not meet the requirements of the written decision not to issue a license, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration or administrative litigation according to law.
Baidu Encyclopedia - Class II Medical Devices
Baidu Encyclopedia - Medical Devices