Following the adjustment of the drug, on April 6, the State Food and Drug Administration official announced the “Decision on Adjusting the Approval Procedure for Some Medical Device Administrative Examination and Approval Itemsâ€, and decided to approve the third-class high-risk medical device clinical trial and the domestic third-class medical treatment. The decision on the approval of the change of the licenses for imported devices and imported medical devices, the decision on the approval of the continuation of the registration of domestically produced Class III medical devices and imported medical devices shall be adjusted to be made by the Medical Device Technology Evaluation Center of the State Food and Drug Administration in the name of the State Food and Drug Administration. The decision will take effect on July 1, 2017. In 2014, the General Administration of Food and Drug Administration actively implemented the newly revised Regulations on the Supervision and Administration of Medical Devices, and promulgated the Measures for the Administration of Registration of Medical Devices, the Measures for the Registration of In Vitro Diagnostic Reagents, and the Registration and Approval of the Third Class and Imported Medical Devices in China. The Code and other documents clarify the registration and approval of the third category and imported medical devices in China, including acceptance, technical review, administrative examination and approval, and the production of the approval documents. The technical review is under the responsibility of the Medical Device Technical Evaluation Center of the State Administration of Taxation. Be responsible for. After the medical device technical review is over, the Food and Drug Administration will make an approval decision within 20 working days from the date of receiving the technical review opinion. The technical review and administrative examination and approval decisions for some of the examination and approval items were made by the Medical Device Technical Evaluation Center of the State Administration of Taxation. For the adjusted examination and approval items, the work procedures include acceptance, technical review, administrative examination and approval, and approval production. Optimized the approval process. For the approved examination and approval matters, after the approval decision of the Medical Device Technical Evaluation Center of the State Administration of Taxation, the corresponding department of the General Administration shall produce the Medical Device Registration Certificate, the Medical Device Registration Change Document and the Administrative License Determination Decision within 10 working days. And other approvals. Decision of the State Food and Drug Administration to adjust the examination and approval procedures for some administrative approval items for medical devices In order to implement the "Opinions of the State Council on Reforming the Examination and Approval System for Pharmaceutical Medical Devices" (Guo Fa [2015] No. 44) and the State Council's reform of the administrative examination and approval system, further strengthen the registration of medical devices and effectively improve the efficiency of review and approval. The State Food and Drug Administration's bureau meeting decided to adjust the following medical device administrative approval decisions made by the State Food and Drug Administration to the State Food and Drug Administration Center for National Food and Drug Administration. The name of the General Administration made: First, the third type of high-risk medical device clinical trial approval decision; Second, the decision to change the approval of the domestic third-class medical devices and imported medical device licensing items; Third, the domestic third-class medical equipment and imported medical equipment continued to be approved for registration. The examination and approval of other medical device registration applications shall be made by the State Food and Drug Administration according to the current procedures.
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