The NMPA published the “Announcement on Standardizing the Classification of Medical Devices” on May 11, 2024. It revises the classification processes for devices, combination products and newly developed medical devices, and standardizes the classification materials. NMPA will implement these new rules from September 1, 2024.
Newly Developed Medical Devices
China NMPA does not have De Novo process like FDA’s. When a device is newly developed, NMPA mentioned in the document that, manufacturers may opt to either apply for Class III registration or apply for classification.
Newly developed medical devices refer to those that, compared to the products listed in the Classification Catalog (based on product description, intended use, and examples of product names) and those already on the market, are entirely new in terms of primary raw materials, manufacturing process, working principle, structural composition, usage method, contact location and duration, and intended purpose, and have not yet been marketed in our country.
Manufacturers apply for classification at Center for Medical Devices Standardization Administration (https://www.nifdc.org.cn)
Classification Materials
The document lists the following main contents and details the format and requirements. For more information, please email info@ChinaMedDevice.com.
- Product Name
Must adhere to “Medical Device Generic Naming Rules”.
Recommended to use names from the “Classification Catalog”.
- Intended Use
Clearly specify the intended use.
If multiple uses, list each one.
For treatment or diagnosis, specify the disease targeted.
For auxiliary treatment or diagnosis, specify the main role and disease targeted.
- Structural Composition
Provide detailed, specific product descriptions.
List all components clearly.
For products like gels, liquids, ointments, or coatings, specify the names and amounts of all chemical components.
Detail the composition, amounts, and uses of ingredients with pharmacological, immunological, or metabolic effects.
- Working Principle and Mechanism of Action
Clearly explain the working principle and mechanism of action.
For multi-component products, list names, amounts, functions, and mechanisms of all components.
Provide documentation for components not listed in the Chinese Pharmacopoeia if they are claimed to lack pharmacological effects.
For active products, include main technical parameters.
For software products, indicate if AI algorithms are used and if diagnostic conclusions are provided.
- Usage Form, Status, Site, Duration, and Method
Detail clinical use, contact sites, duration, and steps.
Provide supporting photos, images, or videos.
For products used with others, list names, compositions, uses, and interaction methods.
- Material Characteristics
For in vitro diagnostic products, detail material, production process, and reaction system.
For non-active products, describe material and production process.
For active products, specify materials in contact with the body.
- Models/Specifications
List all models/specifications and explain the principles of their differentiation.
- Main Risk Points
Identify risk points, including potential for harm during normal use and if the device fails, and impact on treatment/diagnosis.
- Domestic and Foreign Similar Products
Summarize management status, names, functions, and uses of similar products.
Compare the application product with similar products, detailing similarities and differences.
- Applicant’s Claims and Reasons
Define the management category and attributes with justification.
Provide examples aligning with the “Classification Catalog” and “Classification Rules”.
Takeaways from Classification Procedure
- If the relevant content in the registration documents (such as primary materials, manufacturing process, working principle, structural composition, usage method, contact location and duration, intended purpose, etc.) is inconsistent with the classification materials or classification notification, the classification result does not apply.
- The classification of products applying for innovative devices shall be handled in accordance to the relevant provisions of the Innovation Device Approval Procedure
- The classification results are based on the information provided by the applicant and serves as an important guidance for the registration. However, it does not signify endorsement of the product’s intended use or its safety and effectiveness. The product description and intended use in the results are used to assess the product’s regulatory attributes and classification and do not represent the relevant product’s registration content.
- The document attaches the following files as annexes:
- Procedure for Classifying Newly Developed Medical Devices Not Yet Listed in the “Classification Catalog”
- Procedure for Classifying Medical Devices with Uncertain Management Categories
- Requirements for Medical Device Classification Application Materials
- Medical Device Classification Application Form (Template)
- Notification Letter for Medical Device Classification Application (Template)
- Classification Procedure for Special Circumstances
