Urgently Need Medical Devices for Priority Approval for Medical Devices

  Author:MeCan Medical–ultrasound machine manufacturers

On August 31, the General Administration of Supervision and Management of my country released the "Measures for Registration and Records of Medical Devices", some diagnosis or treatment of rare diseases, malignant tumors, unique and multiple diseases, and medical devices specifically used for children. It will take priority approval to allow more patients to treat them in time. The management measures were approved by the 11th Bureau of the General Administration of Market Supervision on July 22, 2021, and will be implemented from October 1, 2021.

The "Measures" summarize the results of the review and approval of medical device review and approval in recent years, add special registered procedures, and incorporate special registration procedures such as innovative product registration procedures, priority registration procedures, and emergency registration procedures. Procedures, support policies, etc.

The "Measures" stipulates the emergency registration procedure of medical device, clarifying that my country's pharmaceutical supervision bureau can need emergency need for emergencies in public health events in accordance with the law, and there is no similar product in my country in China, or although similar products have been listed in my country, but Product supply cannot meet the emergency registration required for emergency treatment of public health events.

The "Administrative Measures for Registration and Records of Medical Devices" and the "Administrative Measures for the Registration and File of End Diagnostic reagents" are supportive execution documents of the "Regulations on the Supervision and Administration of Medical Device", which are the improvement and refinement of the registration and filing management system.

Incorporate the expandable clinical trials into it, it stipulates that medical devices that are used for clinical trials for the treatment of severe life and no effective treatment can be used to benefit patients after medical observation. Institutions that can conduct medical device clinical trials are used for free patients with the same condition, and their safety data can be used for medical device registration applications.

Urgently Need Medical Devices for Priority Approval for Medical Devices 1

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