Healthcare, Industry News, Medical Devices, Regulatory Affairs

CFDA announces classification adjustments and UDI submission guidelines

CFDA have announced two important medical devices regulatory, first about the classification changes, and the second regarding the submission of unique device identifier (UDI) data.

Adjustments in classification catalog

NMPA has partially revised the Medical Device Classification Catalog, as discussed in Announcement No. 147 of 2020 (link in Chinese). Considerable changes include 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 the respective annexes attached to the announcement.

UDI-DI electronic submission

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.

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