Class II medical devices include thermometers, sphygmomanometers, electrocardiographic diagnostic instruments, medical cotton wool, medical gauze, thermostatic incubators, glass cupping, X-ray film machine, ultrasound, microscope, biochemistry and so on.
What is included in Class II medical devices
X-ray film machine, ultrasound, microscope, biochemical instrument belongs to Class II.
Class II refers to medical devices whose safety and effectiveness should be controlled.
The opening of the second class of medical equipment manufacturers must have the following conditions:
(a) the person in charge of the enterprise should have secondary education or junior title.
(B) the person in charge of the quality inspection organization should have college education or above, or above the intermediate title.
(c) the enterprise should occupy the corresponding proportion of the total number of employees of junior title or above engineering and technical personnel.
(d) enterprises should have the appropriate product quality inspection capabilities.
(E) should be compatible with the production of products and scale of production, warehousing sites and environment.
(F) has the appropriate production equipment.
(vii) The enterprise shall collect and save the laws, regulations, rules and relevant technical standards related to the production and operation of the enterprise.
(viii) the production of sterile medical devices, should have a production site in line with the provisions.
Retail pharmacies Class II medical device business scope:
X-ray film machine, ultrasound, microscope, biochemistry instrument belongs to Class II.
Class II means that the safety and effectiveness of medical devices should be controlled.
The application process for Class II medical devices:
1, the application does not belong to the department's terms of reference, it should be made immediately inadmissible decisions, and inform the applicant to the relevant administrative organs;
2, the application materials can be corrected on the spot, the error, the applicant should be allowed to correct on the spot;
3, the application materials are incomplete Or does 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 late notification, since the date of receipt of the application materials shall be accepted;
4, the application materials are complete, meet the requirements of the formal review, or the applicant in accordance with the requirements to submit all the corrections to the application materials, to be Admissible.
Legal basis:
Regulations for the Supervision and Administration of Medical Devices (Revised in 2021)
Article 14 The filing of Class I medical device products and application for registration of Class II and Class III medical device products shall be submitted with the following information:
(1) Risk analysis of the product information;
< p>(ii) product technical requirements;(iii) product inspection reports;
(iv) clinical evaluation information;
(v) product specifications as well as labeling samples;
(vi) with the product development, production and quality management system documents;
(vii) prove that the product is safe, effective and other information required.
The product inspection report shall comply with the requirements of the State Council Drug Administration, can be the applicant for registration of medical devices, the filer of the self-inspection report, or commissioned by a qualified medical device inspection agency issued the inspection report.
Conforms to the provisions of Article 24 of the Regulations exempt from clinical evaluation of the situation, may be exempt from submitting clinical evaluation information.
Applicants for registration of medical devices, the filer shall ensure that the information submitted is legal, true, accurate, complete and traceable.