Drugdu.com expert's response:

There are significant differences between the Class II medical device registration and the Class III license in various aspects, mainly embodied in the risk levels of medical devices covered, management requirements, and application procedures. Below are detailed distinctions and their respective application procedures:

1.Differences

Risk Levels and Management Requirements

Class II Medical Devices: Pose moderate risks and require strict control management to ensure their safety and effectiveness. The safety and efficacy of these devices must be regulated to prevent unnecessary risks to patients or users during use. Examples include X-ray machines, B-mode ultrasound scanners, microscopes, biochemical analyzers, etc.

Class III Medical Devices: Represent the highest level of medical devices and are subject to the strictest control. These devices are often implanted into the human body or used to support or sustain life, and their failure can cause severe harm or even death to patients. Therefore, their safety and efficacy must be rigorously controlled. Examples include implantable cardiac pacemakers, artificial joints, etc.

Application Procedures and Supervision

Class II Medical Device Registration: Relatively straightforward. Enterprises or individuals need to register with the municipal food and drug administration department of the location and fill out the Registration Form for the Operation of Class II Medical Devices, submitting relevant materials. Upon approval, a Registration Certificate for the Operation of Class II Medical Devices will be issued. Additionally, if enterprises sell Class II medical devices on e-commerce platforms, they must also register for online sales.

Class III Medical Device License: Involves a more rigorous process. Enterprises must submit registration application materials, including product risk analysis, technical requirements, inspection reports, etc., to the National Medical Products Administration. Only after rigorous on-site audits, inspections, and tests can they obtain a Medical Device Business License.

2.Application Procedures

Application Procedures for Class II Medical Device Registration

①Registration Application: Enterprises engaged in the operation of Class II medical devices must register with the municipal food and drug administration department of their location.

②Submission of Materials: When registering, enterprises need to fill out the Registration Form for the Operation of Class II Medical Devices and submit relevant materials, including but not limited to copies of the business license and organization code certificate, identity and educational or professional qualification certificates of the enterprise's responsible person and quality control person, property ownership documents and lease agreements of the warehouse address, directories of operating facilities and equipment, etc.

③Materials Review: The food and drug administration department will verify the completeness of the submitted materials. If the application materials are complete and comply with legal requirements, the registration materials will be accepted, and a Registration Certificate for the Operation of Class II Medical Devices will be issued.

④Collecting the Certificate: After passing the review, enterprises need to collect the Registration Certificate for the Operation of Class II Medical Devices from the food and drug administration department.

Application Procedures for Class III Medical Device License

①Preparing Materials: Operating enterprises need to prepare and submit detailed registration application materials, including the Application Form for Medical Device Business License, pre-approval documents for enterprise names issued by the administrative department for industry and commerce, identity and educational or professional qualification certificates of quality management personnel of the proposed enterprise, etc.

②Submission of Application: Applicants should submit the application for issuing the Medical Device Business License to the provincial, autonomous region, or municipality directly under the central government's (food) drug administration department or the designated municipal (food) drug administration institution in the district where the proposed enterprise is located.

③Review and On-site Inspection: The regulatory department will review the application materials and may conduct on-site inspections to verify whether the actual situation of the enterprise meets the requirements.

④License Issuance: If the application is approved, the regulatory department will issue the Medical Device Business License.

III. Precautions

The above procedures are for reference only, and the specific application process may vary by region and circumstances. It is recommended to consult the local food and drug administration department or relevant agencies about the specific application process and required materials before proceeding.

Both the Class II registration and Class III license application processes must strictly comply with relevant national laws, regulations, and provisions to ensure the legitimacy and compliance of business activities.