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The announcement of the state administration of pharmaceutical administration on the amendment of pa

Date:2018-09-04Source:
To implement the general office of the central committee of the communist party of China, the state council general office "about deepening the review of the opinions of the examination and approval system reform to encourage pharmaceutical medical equipment innovation" word [2017] no. 42 (hall), implement the deepening the reform of "pipes" requirements of the state council, further simplify and optimize medical instrument for examination and approval of registration, clinical trials, improve the efficiency of review for examination and approval, the state department of pharmaceutical administration organization changed the part such as medical devices continue to register declare information requirement, modify specific content see attachment. This announcement shall take effect as of the date of promulgation.


Hereby notice.




The attachment


Medical devices continued registration and other parts of the declaration data required to revise the content


1. Revised contents such as requirements and instructions for continuing registration and declaration of medical devices

Declaration data released on the medical device registration and approval documents required format of the announcement (state administration of food and drug supervision and administration of 43, 2014) announced the attachment 5 registered medical devices continue to declare materials requirements and descriptions of item 5 "certificate period of validity of product analysis report" and the content of the published on the in vitro diagnostic reagent for registration and approval documents required filings announcement of format (the state food and drug administration bureau announcement no. 44 in 2014). 4 the in vitro diagnostic reagents continue registration filing requirements and descriptions of item 5 "certificate period of validity of product analysis report" All contents are modified as follows:

"V. if the original registration certificate of medical devices sets out the requirements for continued completion of the work, relevant summary report shall be provided and relevant information shall be attached."

2. Revised contents of "requirements and instructions for the approval and application of clinical trials of medical devices"

Declaration data released on the medical device registration and approval documents required format of the announcement (the state food and drug administration administration announcement 43, 2014) annex 7 for examination and approval of the medical device clinical trials reporting data requirements and instructions in the second sex "documents" in subparagraph (2) the content of the "outside the applicant shall submit a" changed to:

"(2) overseas applicants shall submit:

A copy of the letter of authorization, the letter of commitment and the duplicate of the business license or the copy of the registration certificate of the foreign applicant's designated agent within the territory of China."

The ninth item in annex 7 "written opinions of the ethics committee agreeing to conduct clinical trials" is revised as follows:

"9. The ethics committee agrees with the written opinions on the conduct of clinical trials

If a clinical trial is to be carried out in a multi-center, the written opinion of the ethics committee of the lead unit agreeing to the conduct of the clinical trial shall be submitted. If a clinical trial is to be carried out in a non-multi-center setting, the written consent of the ethics committee of all the clinical trial institutions shall be submitted."
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