【EXPERT Q&A】Do Class II medical device operations require a “license”?
June 12, 2026
Source: drugdu
30
Drugdu.com expert's response:
No. You don't need a "license" for Class II medical devices — you only need to file a record .
To be precise, the term "Class II Medical Device Operation License" itself is incorrect. According to Article 30 of the Medical Device Supervision and Administration Regulations:
Class I: No license required, no filing required
Class II: No license required, but filing is mandatory. You obtain a Class II Medical Device Operation Filing Certificate
Class III: License required. You apply for a Medical Device Operation License
So the correct procedure for Class II is: submit filing materials to the municipal-level drug administration department where the enterprise is located. If materials are complete and meet requirements, the certificate is issued on the spot.
The filing certificate has no fixed expiry date. When enterprise information changes, a change filing must be processed. When operations cease, the filing must be actively cancelled.
By editor
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