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China Registration Certificate Management Service

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The validity period of the medical device registration certificate is stipulated according to the classification of medical device products. During this validity period, medical device companies can produce and sell medical devices in accordance with the provisions of the registration certificate.
Medical device registrants, filers, and entrusted manufacturing enterprises shall regularly conduct self-examinations on the operation of the quality management system and submit self-inspection reports in accordance with the regulations of the State Council’s drug regulatory department.
According to relevant regulations, if an enterprise wants to organize activities related to the manufacturing of Class II and Class III medical devices, it should apply for a manufacturing license from the Food and Drug Supervision and Administration Department of the local province, autonomous region, or municipality directly under the Central Government.
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