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Announcement of Jiangsu Provincial Drug Administration on Implementing Online Handling of Administrative Approval Matters for Medical Devices 2022 No. 10
Published Time：
2022-04-27
In order to further promote the administrative approval of medical devices in Jiangsu Province and strengthen service guidance, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", "Administrative Measures for Medical Device Registration and Filing", "Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents", and "Medical Device Production Supervision and Administration Measures" and other laws and regulations, combined with the State Drug Administration's "Announcement on the Announcement of the Format of Medical Device Registration Application Materials and Approval Documents", "Announcement on the Announcement of In Vitro Diagnostic Reagent Registration Application Materials Requirements and Approval Document Formats", "On the Implementation of "Medical Device Registration Application Materials" According to the requirements of the “Measures for the Supervision and Administration of Device Production” and the “Measures for the Supervision and Administration of Medical Device Operation” and other requirements, from May 1, 2022, all the administrative examination and approval matters for medical devices in Jiangsu Province will be handled online, and the relevant matters are hereby notified. as follows:
1. The registrant (registration applicant) and the entrusted production enterprise shall comply with the requirements of the "Administrative Measures for Registration and Filing of Medical Devices", "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents", and "Administrative Measures for the Supervision and Administration of Medical Device Production" and assume corresponding obligations responsibility.
2. The applicant logs in to the "Jiangsu Provincial Drug Administration Medical Device Administrative Approval System" through the Jiangsu Government Service Network, fills in the application information, and uploads the relevant application materials in accordance with the requirements of the relevant work guidelines of the Jiangsu Government Service Network (see the attachment for details).
3. Applications that have been submitted offline but have not yet completed the acceptance review will still be accepted and reviewed according to the original acceptance criteria, and those that meet the requirements will be accepted; if the application does not meet the requirements, if the registration applicant completes the correction within 5 working days at one time, If the application is accepted, and the corrections are not completed at one time as required, the registration applicant shall re-apply in accordance with the latest requirements of this notice.
4. For medical device production license applications that have been accepted but not yet approved before May 1, 2022, after the implementation of the newly revised "Measures for the Supervision and Administration of Medical Device Production", those who meet the requirements will be processed and issued according to the new time limit. Production License.
announce.
Jiangsu Provincial Drug Administration
April 2022
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