In order to further promote the administrative approval of medical devices in Jiangsu Province and strengthen service guidance, in accordance with regulations and rules such as the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Registration and Filing of Medical Devices", "Measures for the Registration and Filing of In Vitro Diagnostic Reagents", "Measures for the Supervision and Administration of Medical Device Production", and "Measures for the Supervision and Administration of Medical Device Production", and "Measures for the Supervision and Administration of Medical Device Production", and "Measures for the Supervision and Administration of Medical Device Production", and "Measures for the Supervision and Administration of Medical Device Production", all administrative approval matters for medical devices in Jiangsu Province will be transferred to online processing from May 1, 2022, The relevant matters are hereby announced as follows: 1、 The registrant (applicant for registration) and the entrusted manufacturing enterprise shall comply with the requirements of the "Management Measures for Registration and Filing of Medical Devices", "Management Measures for Registration and Filing of In Vitro Diagnostic Reagents", "Management Measures for Supervision and Administration of Medical Device Production", and bear corresponding obligations and responsibilities. 2、 The applicant logs in to the "Medical Device Administrative Approval System of Jiangsu Provincial Drug Administration" through the Jiangsu Government Service Network, fills in the application information, and uploads the relevant application materials according to the requirements of the relevant service guidelines of Jiangsu Government Service Network (see 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. Those that meet the requirements will be accepted; If the applicant does not meet the requirements and completes the correction in one go within 5 working days, it will be accepted. If the applicant fails to complete the correction in one go as required, they should reapply according to the latest requirements of this notice. 4、 Medical device production license applications that have been accepted but not yet approved before May 1, 2022, will be processed and issued according to the new time limit requirements for those that meet the conditions after the implementation of the newly revised "Medical Device Production Supervision and Management Measures". This is to inform you.
 Attachment: 1.Requirements and instructions for the application materials for the registration of Class II medical devices intended for market launch. zip

2.Requirements and Instructions for Application Materials for Continued Registration of Class II Medical Devices. zip

3.Requirements and Instructions for Filing and Registration Application Materials of Class II Medical Devices. zip

4.Requirements and Instructions for Registration Application Materials of Class II In Vitro Diagnostic Reagents. zip

5.Requirements and Instructions for Application Materials for Continuation Registration of Class II In Vitro Diagnostic Reagents. zip

6.Requirements and instructions for filing or applying for registration changes of Class II in vitro diagnostic reagents. zip

7.Requirements and Instructions for Application Materials for Production License of Class II and III Medical Devices. zip

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