Drugdu.com expert's response:

The medical device Class II registration and Class III license differ significantly in various aspects, including risk level, management approach, handling authority, scope of application, approval process, and regulatory intensity. Below is a detailed elaboration on these differences in English:

I. Risk Level

Class II Medical Devices: Pose moderate risks and require strict control and management to ensure their safety and effectiveness. These devices are typically used for prevention, diagnosis, monitoring, treatment, or alleviation of diseases in human extracorporeal organs, tissues, or bodily fluids, employing various technological means that may pose moderate risks to the human body. Examples include thermometers, sphygmomanometers, electronic blood pressure and pulse meters, acupuncture needles, magnetic therapy devices, hearing aids, infusion pumps, and electrocardiographs.

Class III Medical Devices: Pose high risks and require special measures for strict control and management to ensure their safety and effectiveness. These devices are commonly used for diagnosing, treating, or monitoring human diseases and, if used improperly, may have serious health implications for patients. Examples include infusion sets, syringes, heart stents, implantable pacemakers, contact lenses, intraocular lenses, ultrasonic tumor ablation knives, and hemodialysis devices.

II. Management Approach

Class II Medical Devices: Subject to registration management. The registrant shall submit registration information to the municipal food and drug administration of the locality where it is located before registration. The regulatory authority will review the materials and conduct site inspections, issuing a Class II Medical Device Registration Certificate upon approval.

Class III Medical Devices: Subject to licensing management. Applicants need to submit application materials to the National Medical Products Administration (NMPA) or provincial food and drug regulatory authorities. The regulatory authorities will review the materials and conduct site inspections, issuing Class III Medical Device Production Licenses and Operation Licenses upon approval.

III. Handling Authority

Class II Medical Device Registration: Handled by the municipal food and drug administration.

Class III Medical Device License: Handled jointly by the NMPA, provincial food and drug regulatory authorities, and municipal food and drug regulatory authorities, but the specific approval work is primarily conducted by the NMPA or provincial food and drug regulatory authorities.

IV. Scope of Application

Class II Medical Device Registration: Applies to operators engaged in Class II medical device business activities.

Class III Medical Device License: Applies to operators engaged in high-risk Class III medical device business activities.

V. Approval Process

Class II Medical Device Registration: Relatively straightforward, including preparing registration materials, submitting them to the municipal food and drug administration, having the regulatory authority review the materials and conduct site inspections, and issuing a registration certificate upon approval.

Class III Medical Device License: Relatively complex, requiring detailed application materials, including enterprise qualifications, product technical documentation, quality management system files, etc., submission to the NMPA or provincial food and drug regulatory authorities for review and site inspections, and issuance of a license upon approval.

VI. Regulatory Intensity

Class II Medical Device Registration: Relatively lighter regulation, relying mainly on the self-discipline and consciousness of operators.

Class III Medical Device License: Relatively heavier regulation, requiring regular site inspections and audits to ensure operator compliance and product safety.

In summary, Class II medical device registration and Class III medical device licenses differ significantly in risk level, management approach, handling authority, scope of application, approval process, and regulatory intensity. Operators should choose the appropriate qualification certificate based on their business scope and product characteristics and strictly comply with relevant regulations and requirements to ensure product safety and effectiveness.