Matters concerning the filing of Class I medical devices (including Class I IVDs) are hereby announced as follows:
- 1. Filing of medical devices means the registrant submits required documents to the medical products administration according to the related regulations and procedures.
- 2. Registrants submit the documents to the medical products supervision department at the city level for domestic products, while to NMPA for imported medical devices.
- 3. For assessing the category of the product, it should be referred to the description of the product, intended use and examples of nomenclature according to the “Catalog of Class I Medical Devices”, “Sub-catalog of IVD” etc..
- 4. Registrants should submit the documents complying with the requirements (see attachment 1), fill up the application form (attachment 2) when applying for filing of medical devices in order to obtain a filing number.
- 5. The filing of medical devices is completed after the registrants submit the documents complying with the requirements in attachment 1. The filing department will provide registrants the filing number (see attachment 3) and publish related information in the “Class I Medical Devices Filing Information Table” or “Class I In Vitro Diagnostic Filing Information Table” (see attachment 4).
- 6. If there is any change to the content of the filing information table and the technical requirements of filing product, the registrant should apply for an amendment to the original filing department.
- 7. The filing department should carry out the tasks in accordance with the operation specification of class I medical devices (see attachment 5).
- 8. The filing number of class I medical devices follows: ×1械备××××2××××3
- 9. NMPA builds a platform for collecting filing of class I medical devices. The provincial medical products administrations are responsible for the collection and submission of information on the filing of class I medical devices within their respective jurisdictions. For filing, the filing department shall publish the relevant information on its website in prescribed time and the provincial medical products administrations shall report the filing information of domestic class I medical devices to the platform of NMPA.
For amendment of filing, the filing department shall post the amendment in the filing information table on its website. While the provincial medical products administrations shall report the amendment information to the platform of NMPA.
This announcement came into force from the date of publication. The announcement no.26 of 2014 shall be abolished at the same time.
- 1. Requirements and instructions for filing of class 1 medical devices
- 2. Application form for filing of class I medical devices (template)
- 3. Declaration letter of filing number
- 4. Class I medical devices filing information table and class I in vitro diagnostic filing information table
- 5. Operation specification of class I medical devices