Class II filing process of medical devices:
1. Enter the Class II medical device service platform of the Market Supervision Bureau to inquire about all the handling details.
2. Log in with the user's account, because only the related enterprise information can be handled normally.
3. After passing the examination, you can issue and print out the second-class medical record certificate by yourself.
Legal objectivity:
Article 21 of the Regulations on the Supervision and Administration of Medical Devices
Where the design, raw materials, production technology, scope of application and usage of the registered Class II and Class III medical devices have substantially changed, which may affect the safety and effectiveness of the medical devices, the registrant shall apply to the original registration department for change of registration; Other changes shall be filed or reported in accordance with the provisions of the drug supervision and administration department of the State Council.