Chinese regulators announce classification adjustments and UDI submission guidelines

Two important updates for regulation of medical devices in China were announced near the change in the calendar year. The first relates to classification changes, and the second provides details on the submission of unique device identifier (UDI) data.

NMPA adjusts classification catalog and down-classifies some medical devices

The National Medical Products Administration (NMPA) has partially revised the Medical Device Classification Catalog, as described in Announcement No. 147 of 2020 (link in Chinese). Noteworthy changes consist of the down-classification of 15 device types (including optical endoscopes and medical microscopes) and revisions to the entries for 13 product categories (including additional classification adjustments). The changes are summarized in annexes attached to the announcement. 

As of December 31, 2020, registration and filing applications must be submitted according to the adjusted classification catalog. Applications that have been accepted but not yet approved (including both initial registration and renewal applications) will be reviewed and approved according to the previous version of the catalog, and the registration certificate will indicate the adjusted classification or category. For registered devices, the registration will remain valid until expiration, but classification information may need to be adjusted upon the next renewal. If there are any changes during the validity period, the applicant must apply for these changes based on the original version of the catalog, and the registration certificate will include an indication of the adjusted classification.

CMDE announcement addresses UDI-DI electronic submission

The Center for Medical Device Evaluation (CMDE) issued its Announcement No. 26 of 2020 (link in Chinese), relating to the submission of UDI information. China’s UDI pilot program wrapped up at the close of 2020; it was previously slated to end in October, but the NMPA extended this trial period due to the impact of the COVID-19 pandemic. Compliance with UDI requirements will now be enforced for the first batch of devices in the agency’s phased implementation plan.

The announcement deals with UDI-DI submission via the eRPS system for medical device registration applications. An attachment to the announcement provides a list of the medical device categories currently subject to UDI requirements, and applicants with devices on this list must complete and upload UDI-DI information according to the template provided when submitting a registration, renewal, or modification application in the eRPS system.

Learn more about medical device regulation in China with Emergo by UL:

• China NMPA medical device registration and approval consulting
• Medical device clinical and testing requirements assessment for China
• Whitepaper: China NMPA medical device registration
• Webinar: Medical device registration in China