Answer: Yes, under certain conditions.
If the imported device is already registered, and the foreign manufacturer establishes or controls a China-based company, the product may be localized under Announcement No. 30 (2025).

✅ We assist with transition planning and localized registration for previously imported devices.

A registration amendment is required.
You must submit updated supporting documents, such as:
▶ New QMS or site qualification certificates (if applicable)
▶ Updated Free Sales Certificate (FSC) or marketing authorization (if required)
▶ An explanation if no new approval is needed in the original country

● For innovative devices not yet listed overseas, FSC may be waived.

Yes.
The manufacturing site must meet relevant Chinese medical device production requirements and accept potential inspections organized by NMPA.

A: Not always.
For Class II and III imported devices, the NMPA may request a QMS inspection based on the outcome of the technical review. If required, the NMPA Inspection Center will organize an overseas audit.

● BiomenGroup can coordinate QMS readiness and audit support for your overseas site.