What are Some Different Types of Medical Supplies?

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray film machines, B-mode, microscopes, biochemical instruments, etc. belong to the second class of medical equipment.

Class II medical devices

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray film machines, B-mode, microscopes, biochemical instruments, etc. belong to the second class of medical equipment.

Chinese name

Class II medical devices

Types of

The second category refers to medical devices whose safety and effectiveness should be controlled.

X-ray camera, B-ultrasound, microscope,

"Medical Device Classification Catalog" ^[1]

According to the Regulations on the Supervision and Administration of Medical Devices ^[2]

The establishment of a second-type medical device manufacturing enterprise must meet the following requirements:
(1) The person in charge of the enterprise shall have a technical secondary school education or above or a junior title or above.
(2) The person-in-charge of the quality inspection agency shall have a college degree or above or an intermediate title.
(3) Engineering and technical personnel with junior titles or above in the enterprise shall occupy the corresponding proportion of the total number of employees.
(4) The enterprise shall have corresponding product quality inspection capabilities.
(5) There should be production and storage sites and environments that are compatible with the products and scale produced.
(6) Have corresponding production equipment.
(7) The enterprise shall collect and keep laws, regulations, rules and related technical standards related to the production and operation of the enterprise.
(8) For the production of sterile medical equipment, it shall have a production site that meets the requirements.

The applicant logs on the Beijing Drug Administration's enterprise service platform for online declaration. According to the scope of acceptance, the following application materials must be submitted: ^[3]

Second category, first

Upon receipt of the application, the province, autonomous region, or municipality (food) and drug administration department shall deal with it separately according to the following circumstances:
(1) If the application matters do not fall within the scope of authority of the department, it shall immediately make a decision not to accept the application and inform the applicant to apply to the relevant administrative organ;
(2) If there are errors in the application materials that can be corrected on the spot, the applicant should be allowed to correct them on the spot;
(3) If the application materials are incomplete or do not meet the formal examination requirements, the applicant shall be issued a "Supplementary Material Notification Letter" on the spot or within 5 working days, informing the applicant of all the content that needs to be corrected at one time. , Will be accepted from the date of receiving the application materials;
(4) If the application materials are complete and meet the requirements of formal examination, or if the applicant submits all the application materials for correction in accordance with the requirements, it shall be accepted.
If the province, autonomous region, or municipality (food) drug regulatory authority accepts or does not accept an application for the establishment of a medical device manufacturing enterprise, it shall issue a "Notice of Acceptance" or "Notification of Inadmissibility" stamped with the special seal of the department's acceptance and dated. book".

If it meets the requirements after examination, it shall make a written decision to grant a license, and issue the Medical Device Manufacturing Enterprise License within 10 working days. If the review does not meet the requirements, it shall make a written decision not to issue a certificate, explain the reasons, and inform the applicant of its right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with the law.