China class I medical device filing has been made clearer thanks to an announcement issued by the National Medical Products Administration (NMPA) on August 12, 2022.
The Announcement on Matters Related to the Filing Of Class I Medical Devices (including in vitro diagnostic reagents) is No. 62 of 2022 and repeals the 2014 version (No. 26 of 2014).
The “Announcement” clarified the following:
- For the filing of domestic Class I medical devices, the filing entity shall submit the filing documentation to the department responsible for supervision and administration at the municipal district level (provincial Medical Products Administration or MPA).
- For the filing of imported Class I medical devices, the filing entity shall submit the filing documentation to the NMPA.
- When determining the product management category, the product description, expected use and product name examples shall be determined according to the product description, expected use and product name examples in:
- the “Class I Medical Device Product Catalogue”
- and “In Vitro Diagnostic Reagent Classification Sub-Catalogue”
- To undertake correct filing of medical devices, the filing entity shall submit filing documentation that meets the requirements, complete the filing form, and obtain a filing number.
- The filing entity shall ensure that the submitted documentation is legal, true, accurate, complete and traceable. Once the filing entity submits the required filing documentation, the filing is completed.
- Data requirements for Class I medical device filing:
- Class I medical device filing form
- Associated files
- Product technical requirements
- Product inspection report
- Product specification and minimum sales unit label design sample
- Manufacturing information
- Conformity Statement
- The filing department (provincial MPA or NMPA) shall provide the filing entity with a filing number as well as proceed to publishing the relevant information found in the “Filing Information Form for Class I Medical Devices” or the “Filing Information Form for Class I In Vitro Diagnostic Reagents” on the filing information platform.
- The NMPA shall establish a filing information platform to collect the filing information of Class I medical devices.
- Provincial MPAs are responsible for collecting and submitting filing information of the Class I medical devices within their respective jurisdictions.
The main takeaway of this announcement is that the requirements for information are more concise and clearer. What’s more is that the requirements for a safety risk analysis report and clinical evaluation data in the original Announcement (No. 26 of 2014) have been deleted.
Further information
Click here to read the full announcement on China Class I medical device filing clarifications.
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