Beijing, China - The National Medical Products Administration (NMPA) has issued a new announcement (No. 59 of 2024) on May 11, 2024, aimed at strengthening the classification of medical devices in China, with a focus on improving safety and regulatory efficiency.
Key Points of the Announcement:
Clearer Classification Process: The announcement provides a detailed framework for classifying medical devices based on their intended purpose, structure, usage, and working principle. It emphasizes the evaluation of risk levels and the use of scientific knowledge and international best practices.
New Device Classification: Manufacturers of newly developed devices not listed in the "Classification Catalog" can apply for classification determination before registration or filing. This will help ensure that new devices are appropriately classified from the start.
Enhanced Data Sharing: The NMPA will establish a dedicated online system for classification determination, allowing for greater transparency and data sharing among manufacturers, regulators, and other stakeholders.
Special Cases: The announcement outlines specific procedures for classifying devices in emergency situations, for combination products, and for innovative medical devices.
Clearer Guidance for Manufacturers: The announcement provides detailed guidance for manufacturers on how to determine the classification of their products, including the use of relevant regulations, guidelines, and the "Classification Catalog."
Increased Oversight: The NMPA will strengthen oversight of provincial-level authorities on classification determination, ensuring consistency and accuracy.
This announcement represents a significant step towards strengthening medical device classification in China, aiming to ensure safety and improve regulatory efficiency.
MEDTECH NEWS
China Tightens Medical Device Classification Rules to Enhance Safety and Efficiency
16 05 2024The National Medical Products Administration has issued Announcement No. 59 of 2024 to improve the classification management of medical devices. The announcement details the procedures for classifying medical devices based on regulations and guidelines, focusing on factors like intended use and risks. It covers classification for new devices, uncertain categories, and emergency situations during public health crises. The implementation begins on September 1, 2024, replacing the previous classification notification.