1. How should the continuation registration be carried out for products that were registered prior to the implementation of GB 9706.1-2020 and comply with parallel standards and special standards (hereinafter referred to as the new GB 9706 series standards)?
MORE
What are the general ideas and principles for the revision of the Measures for the Supervision and Administration of the Operation of Medical Devices (hereinafter referred to as the Measures)?
MORE
The Quality Management Standard for Clinical Trials of Medical Devices (Announcement No. 28, 2022, hereinafter referred to as the "Standard") has been issued and will come into force on May 1, 2022.
MORE
Recently, the State Pharmacovigilance Administration issued the Circular on the Implementation of GB 9706.1-2020 and Supporting Concurrent Standards and Special Standards (No. 14 of 2023, hereinafter referred to as the Circular).
MORE
What is the background of the Regulations on Supervision and Management of Enterprises' Implementation of the Main Responsibility for Quality and Safety of Medical Devices (hereinafter referred to as "the Regulations")?
MORE
What is the background of the revision of the Supervision and Administration of Medical Device Production" (hereinafter referred to as "the Measures") and the main ideas of the revision?
MORE