In 2016, it was the hard-fought year for the reform of the medical device review and approval system. At the expert symposium at the end of last year, the General Administration Center revealed that in January-November 2016, the Instrument Review Center received a total of 10,416 various review tasks. The number of technical reviews was 10086, an increase of 19% over the same period of the previous year.
Among them, in the first 11 months, the Center for Appraisal received a total of 171 applications for special approval for innovative medical device products, completed 144 reviews, and reviewed 44 items (5 imported products).
In addition, the appraisal center adopts the model of “advance intervention and special person in charge†to provide early guidance for innovative product declaration enterprises, complete technical review of 10 innovative products such as orthopedic surgery navigation and positioning system, and promote the process of innovative medical device R&D and listing. .
In 2017, the review of medical device review and approval is expected to accelerate again. “Innovative medical devices†and the “priority approval of medical devices†launched by the General Administration at the end of 2016 may continue to be the biggest beneficiaries.
On February 7, 2017, the State Food and Drug Administration issued the “Measures for the Administration of Communication and Evaluation of Medical Device Evaluation (Trial)†(hereinafter referred to as “Measuresâ€), which shall be implemented as of the date of promulgation.
Like the “Administrative Measures on Communication and Technology Review Communication and Communication (Trial)†issued in June last year, the “Measures†also clearly establish a communication bridge between the applicant and the drug regulatory reviewers. Thereby improving the efficiency of the review work.
The "Measures" stipulate that in the stage of technical review before the registration application is accepted and the technical review stage, the applicants may submit the meeting and communicate with the inspection center on the registration application. Among them, innovative medical devices can be discussed including major technical issues, major safety issues, clinical trial protocols and test results.
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