China to Adjust Medical Device Classification Catalogues

China has announced that it will adjust its medical device classification catalogues in the following respects:

• Adjustment of sub-catalogues;

• Adjustment of class 1 and class 2 product classification/management classification;

• Supplementation of innovative medical devices of a representative nature;

• Deletion of products no longer subject to management as medical devices; and

• Amendment of product description, expected usage, examples of item names and other content.

According to the announcement, overseas registrants and record-filing persons may entrust their domestic agents to make adjustment suggestions to the department for drug supervision and administration in the province where those agents are located.

Full details can be found in Announcement No. 60 (2021), issued by the National Medical Products Administration, on 27 April. The new rules entered into force with immediate effect.

Source: National Medical Products Administration