Announcement Of The State Drug Administration On Amending The Requirements For Some Application Materials Such As The Continuous Registration Of Medical Devices
2019-09-04
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In order to implement the opinions of the general office of the CPC Central Committee and the general office of the State Council on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices (office Zi [2017] No. 42), implement the requirements of the State Council for deepening the reform of "release, management and service", further simplify and optimize the continuous registration and clinical trial approval of medical devices, and improve the efficiency of review and approval, The State Drug Administration has organized to modify the requirements for some application materials such as the continuous registration of medical devices. See the annex for the specific modifications. This announcement shall go into effect as of the date of promulgation.
Revised contents such as requirements and instructions for application materials for continued registration of medical devices
The contents of item 5 "product analysis report within the validity period of registration certificate" in Annex 5 "requirements and instructions for application materials of continued registration of medical devices" of the announcement on publishing the requirements for registration and application materials of medical devices and the format of approval documents "(Announcement No. 43 of the State Food and Drug Administration in 2014) and the announcement on publishing the requirements for registration and application materials of in vitro diagnostic reagents and the format of approval documents (Announcement No. 44, 2014 of the State Food and Drug Administration) the content of item 5 "product analysis report within the validity period of the registration certificate" in Annex 4 "requirements and instructions for application materials for continued registration of in vitro diagnostic reagents" is revised to: "v. if it is stated in the original medical device registration certificate that it is required to continue to complete the work, relevant summary reports shall be provided and corresponding materials shall be attached."
Revised contents of requirements and instructions for application data of clinical trial approval of medical devices
Paragraph (2) of item 2 "supporting documents" in Annex 7 "requirements and instructions for application materials for clinical trial approval of medical devices" of the announcement on publishing the requirements for registration and application materials of medical devices and the format of approval supporting documents "(Announcement No. 43 of the State Food and Drug Administration in 2014) is amended to read:" (2) The overseas applicant shall submit: the power of attorney, the letter of commitment of the agent and the copy of the business license of the agent designated by the overseas applicant in China, or the copy of the organization registration certificate. "
The content of Item 9 "written opinions of the Ethics Committee on the conduct of clinical trials" in Annex 7 shall be revised as follows:
The ethics committee agrees with the written opinions of the clinical trial
If a clinical trial is carried out in multiple centers, the written opinions of the ethics committee of the lead unit for the approval of the clinical trial shall be submitted; If a clinical trial is conducted in a non multi center, it shall submit the written opinions of the ethics committee of all clinical trial institutions on the approval of the clinical trial. "
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