NMPA Notice On Matters Related To The Filing Of Class I Medical Devices

In order to do a good job in the filing of Class I medical devices, the NMPA issued a notice concerning the filing of Class I medical devices (including Class I IVD) on August 11, 2022.

The Notice clarifies the product management category determination, filing information requirements, post-filing management and other content to further standardize the Class I medical devices (including the Class I IVD) filing-related work.

The Notice further clarifies the nature of filing, emphasizing that the filing entity submits the filing information that meets the requirements of the Class I Medical Device Filing Information Requirements And Instructions is completed after the filing. Also refine the filing information requirements, new product name, product description, intended use, model/ specification and other key content requirements.

As per BradyKnows experiences on Class I medical device filing, the timeline from kicking off project and dossier preparation to getting filing approval is estimated at one month. Our elite team has extensive experience in medical device filings and registration in China, please contact info@bradyknowsmedical.com for any questions.