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| Let go! Medical clinical trial mechanism, no need to approve! |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-7 14:37:07 Number Browse：624 |
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Medical network August 7 - on August 4, the CFDA issued "about for the medical device clinical trial institution conditions and for the record management regulations (draft)" letter ", brewing for medical instrument clinical trial institution let go or will be in a major breakthrough.
Before that, December 17, 2014, on July 20, 2015 CFDA has released two times on the open for the management of medical instrument clinical trial institution qualification cognizance method "(draft) the opinions of notice.
According to a release of "method" requirement, after the state shall implement a medical instrument clinical trial institution qualification authentication system, the CFDA jointly with the national health development planning commission is responsible for the national medical instrument clinical trial institution qualification authentication management work.
The method, carried out in domestic medical device clinical trials, should through the qualification cognizance of professional within the scope of medical institutions, to listed in the catalogue of examination and approval in clinical trials to class iii medical devices, it shall, at the third rate through aptitude professional within the scope of medical institutions to carry out.
However, after two comments, I have not seen the following, so far, no official release has been found.
Yesterday released a new file with the "method", compared to two years ago on the conditions for medical device clinical trials can, can be said to be more rigorous and more refined, a total of 11 lists the terms dedicated "barriers to entry", this 11 conditions include:
1. Professional qualification of medical institution;
2. Having second grade and above qualifications;
3. The third category of medical devices that are subject to clinical trial examination and approval shall be the third grade a medical institution;
4. Having the clinical trial management department of medical devices, equipped with suitable management personnel and office conditions, and having the ability to organize and manage the clinical trials of medical devices;
5. Ethics committee that meets the requirements of the quality management standards of clinical trials of medical devices;
6. Clinical trial management system and standard operating procedures of medical devices;
7. Persons who are subject to the medical devices that are related to the related medical devices for the record, and those who are able to undertake clinical trials of medical devices;
8, medical instrument clinical trial principal investigator should have senior titles, participated in more than three medical device clinical trials, and carry out professional record should be consistent with the practice license of medical institutions diagnosis and treatment subject;
9. The relevant medical services have been carried out to meet the requirements of the subjects required for clinical trials of medical devices;
10. Emergency mechanism and disposal ability of emergency and serious adverse events in clinical trials of medical devices;
11. Other conditions stipulated by the state administration of food and drug administration, the national health and family planning commission.
At the same time, the file is "take the blood center and center of the in vitro diagnostic reagent clinical trial above the level of blood stations and districts of institution of disease prevention and control of medical institutions, should be at least 9 big conditions" has carried on the single row, and in the "method" is not.
It is reported that the filing system can be carried out through the CFDA's filing system, without having to submit the materials on site or pay any fee. But there are a number of documents to be filled in, including a "self-report" that includes seven designated items.
Then the CFDA will by filing system for the record, at the same time released timely medical instrument clinical trial institution name, address, contact person, contact way and main researchers and related information available to the public for inquires.
Wei shaofeng, deputy secretary-general of the China medical materials association, said the regulation was the result of the government's decentralization, but it was not the same as lowering the conditions, but more stringent. With the end of the approval system, the number of clinical trials of medical devices is expected to increase, and clinical trials of medical devices can be achieved more quickly.
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