1. Accurately grasp the management responsibilities of medical device registrants throughout the life cycle under the new system
At present, the competition in the medical device industry is facing a more complex market environment and more arduous transformation challenges. It urgently needs to rely on the global allocation of resource elements, and it urgently needs to rely on institutional innovation to promote development. The new "Regulations" establishes the medical device registrant system as a basic system in the medical device regulatory system. Article 103 of the new "Regulations" clarifies that medical device registrants and filing persons refer to enterprises or research institutions that have obtained medical device registration certificates or handled medical device filings. This system runs through the new "Regulations" and is the "bull nose" of medical device supervision.
Article 13 of the new "Regulations" stipulates that medical device registrants and recorders shall strengthen the quality management of the entire life cycle of medical devices, and shall be responsible for the safety and effectiveness of medical devices in the entire process of development, production, operation and use. Medical device registrants and record holders shall, to fulfill their legal obligations, establish a quality management system compatible with the registered products and maintain effective operation, formulate post-marketing research and risk control plans and maintain effective implementation, carry out adverse event monitoring and re-evaluation in accordance with the law, and establish And implement product traceability and recall system.
Medical device registrants and recorders shall not only carry out research and development activities in accordance with the corresponding laws, regulations and standards for medical devices, and apply for product registration or filing in accordance with the law,
