CDE, the Center for Drug Evaluation (CENTER FOR DRUG EVALUATION) is the technical review organization for drug registration of SFDA (State Food and Drug Administration).
In accordance with the relevant regulations promulgated by the State Food and Drug Administration for the management of drug registration, is responsible for organizing the technical review of drug registration applications. Undertake other matters assigned by the State Food and Drug Administration.
Expanded Information:
SFDA's Main Responsibilities
In order to standardize the management of registration of medical device products, to ensure that the medical devices are safe and effective, according to the "Regulations for the Supervision and Administration of Medical Devices", the State Food and Drug Administration is responsible for the supervision and management of medical devices. Regulations for the Supervision and Administration of Medical Devices", the State Food and Drug Administration to develop medical device registration management.
Medical device registration, refers to in accordance with the legal procedures, the proposed market sales, use of medical devices, the safety and effectiveness of the systematic evaluation, in order to decide whether to agree to its sales, use of the process.
Medical device products sold and used in China shall be declared for registration in accordance with the provisions of these measures, without the approval of the registration of medical devices, shall not be sold and used.
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