Drugdu.com expert's response:

Key Differences Between Class II Medical Device Filing and Class III Medical Device Licensing in China: Risk Tiers, Regulatory Approaches, Scope, Application Processes, and Oversight Intensity

Medical devices in China are categorized into Class II (moderate risk) and Class III (high risk), with distinct regulatory frameworks governing their filing and licensing. Below is a detailed analysis of their disparities:

I. Distinctions Between Class II Filing and Class III Licensing

1. Risk Tiers and Regulatory Approaches

Class II Medical Devices:

Risk Profile: Moderate risk, requiring stringent controls to ensure safety and efficacy.

Regulatory Mechanism: Managed through a filing system, emphasizing post-market accountability.

Class III Medical Devices:

Risk Profile: High risk, with potential for severe health consequences.

Regulatory Mechanism: Subject to pre-market licensing, necessitating rigorous pre-approval scrutiny.

2. Scope of Application

Class II Medical Devices: Intended for extracorporeal prevention, diagnosis, monitoring, treatment, or alleviation of diseases. Examples include thermometers, sphygmomanometers, and hearing aids.

Class III Medical Devices: Used for in vivo disease diagnosis, treatment, or monitoring. Examples include cardiac stents, implantable pacemakers, and hemodialysis equipment.

3. Regulatory Authorities and Approval Processes

Class II Filing:

Authority: Managed by prefecture-level municipal food and drug regulatory departments.

Process:

Prepare filing materials.

Submit documents for review and site inspection.

Obtain filing certificate upon approval (typically 3–5 working days).

Class III Licensing:

Authority: Administered by the National Medical Products Administration (NMPA) or provincial-level regulators.

Process:

Submit application materials.

Undergo on-site verification.

Receive license upon approval (typically 5–7 working days).

4. Oversight Intensity

Class II Filing: Relies on operator self-regulation, with lighter regulatory checks.

Class III Licensing: Subject to intensive oversight, including periodic on-site inspections and audits to ensure compliance and product safety.

II. Step-by-Step Application Processes

1. Class II Medical Device Filing Process

Eligibility Confirmation:

Verify that the business license includes "Class II Medical Device Sales."

Ensure compliance with premises and warehouse requirements.

Staff with relevant professional qualifications.

Material Submission:

Class II Medical Device Business Filing Form

Copy of business license

Identification documents of legal representative and quality manager

Property/lease certificates for business premises and warehouse

Quality management system directory

IT management system description

Review and Certification:
Regulators conduct material review and site inspection, issuing a filing certificate upon approval.

2. Class III Medical Device Licensing Process

Material Preparation: 

Medical Device Business License Application Form

Copy of business license

Identification documents of legal representative and quality manager

Property/lease contracts for business premises and warehouse

Organization code certificate

Medical device quality management documents

Academic/professional title certificates for technical personnel

Application Submission: Submit materials via online or offline channels.

On-Site Verification: NMPA inspectors evaluate premises, warehouses, and quality management systems.

Review and Certification: Upon approval, a 5-year license is issued after comprehensive material and site verification.

Conclusion

Class II and Class III medical device regulations in China differ significantly in risk categorization, regulatory stringency, application processes, and oversight. Manufacturers and operators must align their strategies with these frameworks to ensure compliance and market access.