Second-Class Medical Device Filing (in English)

In China, second-class medical devices refer to those that pose moderate risks and require strict control to ensure their safety and effectiveness. According to the regulations of the National Medical Products Administration (NMPA), such devices must undergo a filing or registration procedure before they can be manufactured, imported, or sold in China.

For second-class medical devices, domestic manufacturers are generally required to complete a registration process with the provincial-level drug regulatory authorities, while certain low-risk second-class devices may qualify for simplified filing procedures. However, most second-class devices require technical evaluation, quality management system review, and clinical evaluation (or exemption documentation).

Key Steps in the Filing/Registration Process:

1. Product Classification Confirmation: Determine whether the product is classified as a Class II medical device under China’s Medical Device Classification Catalog.

2. Technical Documentation Preparation: Compile a comprehensive dossier including product description, design and manufacturing information, risk analysis, performance testing reports, labeling, instructions for use, and clinical evaluation data (if applicable).

3. Quality Management System (QMS) Compliance: Manufacturers must establish and maintain a QMS compliant with YY/T 0287/ISO 13485 standards. A site audit by the local regulator is often required.

4. Submission to Local NMPA Branch: The application is submitted to the provincial drug administration. For filing-type Class II devices, the authority reviews completeness and issues a filing certificate if requirements are met.

5. Obtain Filing Certificate: Upon successful review, the manufacturer receives a Medical Device Filing Certificate (for certain Class II products) or a Medical Device Registration Certificate (for standard Class II devices requiring full registration).

6. Post-Market Supervision: After filing/registration, manufacturers must comply with ongoing obligations such as adverse event reporting, product recalls, and periodic updates to regulatory authorities.

Note: The term "filing" is sometimes used broadly but strictly applies to lower-risk Class I devices and certain Class II devices eligible for simplified procedures. Most Class II devices undergo formal "registration," which involves more rigorous review.

Accurate translation and regulatory strategy are essential for foreign companies entering the Chinese market. Engaging a local Authorized Representative is typically mandatory for non-Chinese manufacturers.

In summary, while "second-class medical device filing" may be used colloquially, the correct regulatory pathway for most Class II devices in China is registration with provincial NMPA authorities, involving technical, quality, and clinical assessments to ensure public safety and product efficacy.