-
-
Qualification
-
R&D Strength
-
Production strength
-
-
Cooperation
-
20
2023
-
12
Focus on institutional development and improve the regulatory framework for medical devices.
The SFDA has actively promoted the revision of the "Regulations on the Supervision and Administration of Medical Devices," organizing and participating in numerous special meetings.
Author:
According to the work arrangements of the Legislative Affairs Office of the State Council, this year the SFDA will continue to promote the revision of the “Regulations on the Supervision and Administration of Medical Devices” (hereinafter referred to as the “Regulations”).
Jiao Hong stated that institutional development is the fundamental basis for effectively carrying out our work and has both a holistic and long-term nature. The Regulations currently under revision will establish and refine a series of systems and mechanisms. We must actively promote the revision of the Regulations, improve supporting rules and normative documents, and ensure that the National Administration develops a comprehensive plan for drafting regulatory and normative documents related to medical device supervision. For those urgently needed, relevant documents can be issued even before the Regulations are promulgated.
It is reported that in 2012, the SFDA actively promoted the revision of the "Regulations on the Supervision and Administration of Medical Devices." It organized and participated in numerous special meetings, cooperated with the Legislative Affairs Office of the State Council to compile and analyze relevant feedback, actively engaged in inter-departmental coordination efforts, and made every effort to advance the revision process of the Regulations. Furthermore, in accordance with the principles set forth in the "Regulations (Third Draft for Comments by the Legislative Affairs Office)," it pushed forward the formulation and revision of supporting regulations and normative documents, such as the "Measures for the Registration Management of Medical Devices."
Meanwhile, efforts have been stepped up to standardize the formulation and revision of normative documents, thereby improving the regulatory framework. The SFDA has formulated and issued a series of normative documents, including the “Notice on Requirements for Registration Work Following the Adjustment of Medical Device Classification,” the “Announcement on the Management of Decorative Colorless Soft Contact Lenses as Medical Devices,” the “Notice on Matters Relating to the Re-registration of Nanosilver Products,” the “Notice on Further Clarifying Implementation Requirements for Raw Materials and Product Standards for Customized Dental Prostheses,” the “Procedures for In-Flight Inspections of Medical Devices,” and the “Notice on Standardizing the Management of Comparative Testing by Medical Device Testing Institutions.” Additionally, the SFDA has organized the development of several regulatory provisions, such as the “Regulations on the Registration Management of Subpackaging of In Vitro Diagnostic Reagents,” the “Inspection and Assessment Criteria for Good Manufacturing Practice for Medical Devices,” the “Interim Regulations on Supervisory Reviews of Medical Device Testing Institutions,” and the “Good Clinical Practice Guidelines for Medical Device Clinical Trials (Trial).”
Additionally, it was reported that in 2013, the SFDA will leverage resources across the entire system to further revise and refine relevant supporting regulations and normative documents, including the "Measures for the Registration Management of Medical Devices." It will also formulate and issue normative documents such as the "Special Approval Procedures for Innovative Medical Devices," the "Good Clinical Practice Guidelines for Medical Device Clinical Trials," and the "Trial Inspection and Assessment Standards for the Good Manufacturing Practice for Medical Devices." Furthermore, the SFDA will organize the development of the "Administrative Measures for the Accreditation of Clinical Trial Institutions for Medical Devices" and the "Catalog of High-Risk Medical Devices for Clinical Trials," along with the procedures for clinical trial approval, thereby strengthening the management of clinical trials involving high-risk medical devices.
The reporter learned at the meeting that this year, the SFDA will continue to actively promote reforms in the medical device registration, review, and approval mechanisms; further strengthen the management of medical device standards and classification; intensify supervision over the production and operation of medical devices; enhance oversight and management of medical device testing institutions; advance monitoring and reevaluation of adverse events; ensure effective implementation of projects under the 12th Five-Year Plan; and earnestly bolster team building and integrity-building within the agency.
Jiao Hong emphasized that we must take “ensuring safety” as our central task, fully implement the 12th Five-Year Plan, and focus on reforming and improving institutional mechanisms. We should strive to establish a regulatory framework characterized by “standardized administrative management, standardized system development, information-based supervision and services, and internationally leading scientific research,” while strengthening talent development and building an honest and clean government. This will help elevate medical device regulation to a new level.
Keywords:
Related News
Xi'an Xuanyu Pharmaceutical Group
Nationwide Unified Customer Service:
Contact phone number:+86 29-89864608
Company email:463879555@qq.com
Address: Room 10402, Unit 1, Building 2, Science and Technology Enterprise Accelerator, No. 6 West Qinling Avenue, Caotang Science and Technology Industrial Base, High-tech Zone, Xi'an City, Shaanxi Province
Official Account
Mobile site
Copyright © 2026 Xi'an Xuanyu Pharmaceutical Group
SAF Coolest v1.2 设置面板 QVPSF-ZMFA-YSSFE-ZWA
无数据提示
Sorry, there is currently no content in this section.!
You can view other sections or return.Home