China – 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…