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General Administration's notice on the inspection of the clinical trials of medical instruments in 2017

2017-12-25  From: Puyang Deg ren medical equipment co. ltd Browsing times:213

For the implementation of the "Regulations" the supervision and administration of medical devices, the implementation of the "State Council on the reform of drug and medical device review and approval system" (Guo Fa 2015 No. 44) requirements, strengthen supervision and management of medical devices in clinical trials, according to 2017 focused on the organization of work, the food and Drug Administration in accordance with the "double random open" in principle, the organization to carry out clinical trial data in the medical device registration application of authenticity, compliance supervision and inspection, and clinical trials of illegal acts, and will publish the results of inspection and supervision to the society. The following matters are hereby announced as follows:


1. Scope of inspection


Clinical trials of the scope of supervision and inspection is a clinical trial project to carry out the food and Drug Administration in the trial registration application before June 1, 2017, including all third types of domestic and imported medical devices to obtain data from clinical trials registered in the territory Chinese through clinical trials for the project. The General Administration of food and Drug Administration will take a comprehensive consideration of factors such as product risk level, complaints and reporting conditions, and extract the inspection items.


Two. Inspection basis


The supervision and inspection on the basis of "medical equipment supervision and management regulations" "medical device registration" (food and Drug Administration Decree No. fourth), "in vitro diagnostic reagent registration" (food and Drug Administration Decree No. fifth), "clinical trials of medical devices quality management standards" (food and drug administration to twenty-fifth No. "), in vitro diagnostic reagents for clinical trial (Study)" and "technical guidelines for clinical trials of medical devices on-site inspection points" (food and Drug Administration announced in 2016 ninety-eighth, Annex 1).


Three. Inspection procedure


The food and Drug Administration will form a inspection team in late July 2017. It will conduct on-site inspections according to the "on-site inspection procedures for medical devices clinical trials" (Bulletin of food and drug administration, 2016 ninety-eighth, annex 2). Before the implementation of on-site inspection, the provincial food and Drug Administration of the corresponding clinical trial institutions, registered applicants (agents), clinical trial institutions and registered applicants (agents) will be informed in written form. The provincial food and drug administration at the location of the clinical trial institution and the registered applicant (each) has appointed an observer to participate in the on-site inspection and coordinate the on-site inspection.


Four. Inspection result processing


The results of the examination are determined according to the following criteria:


(1) the judgment of one of the following cases is that there is a problem of authenticity:


1. the clinical trial data submitted by the registration application are not consistent with the clinical trial data preserved by the clinical trial organization.


2. the data of clinical trials can not be traceable.


3. the test product / test used in vitro diagnostic reagent or test sample is not true.


(two) no real problem is found, but the process of clinical trial does not conform to the requirements of the relevant provisions of medical equipment, and it is judged to be a problem of compliance.


(three) if no authenticity or compliance is found, it is judged to be in conformity with the requirements.


According to the relevant provisions of the administrative licensing law of the People's Republic of China, the regulations for the supervision and administration of medical devices, the registration and management of medical devices, and the registration and management of in vitro diagnostic reagents, etc. If there is only a problem of compliance, a comprehensive evaluation of the registration application data and the problems found in the supervision and inspection will be made to decide whether to approve the registration.


Five. Other matters


(1) the provincial food and drug administration should attach great importance to implementing the requirements of supervision and spot checks, and urge the registered applicants (agents) and clinical trial institutions to make preparations for inspection.


(two) since the announcement of the announcement, a registered applicant may apply for his own withdrawal if he considers that the clinical trial data of his registration application are authentic and serious. The food and Drug Administration issued the announcement of the clinical trials after spot checks, and no longer accepted the application of the registered applicants who had checked the clinical trials.

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