China: CFDA Issues a New Notice on Medical Devices Classification

On March 28, 2013, the CFDA issued a notice about a new online medical device classification system established by the National Institute for Food and Drug Control (NIFDC). Before, device companies seeking classification confirmation for their devices would submit a paper classification to the NIFDC. This committee would review the applications and announce final decisions for the device classifications on the CFDA website several months later.

The new online system is designed for medical device companies that need to apply for classification verification but are unsure about the classification of their product. The new online system will include an application, examination and feedback process.

NIFDC is responsible for the initial examination, classification verification, and pre-classification guidance for products imported from overseas. If classification can be determined, companies will be notified through the online system. If classification cannot be determined through this online system, the medical device company should make classification suggestions to the CFDA Department of Medical Device Supervision for further examination.

In addition to the online application, medical companies must also submit a hard copy of the application and supporting documents to the NIFDC.

Materials Required for Application

  1. Application form for classification
  2. Product photos and/or product structure diagrams
  3. Explanation of product standards (if applicable)
  4. Certificate of Free Sale (only applies to imported products)
  5. Any other related materials for classification