Regulatory Update

Regulatory Update: China

Arazy Group

In a move aimed at bolstering the quality management of medical device operations across China, the National Medical Products Administration (NMPA) issued Announcement No. 153 on December 7, 2023. Titled "Announcement of the State Food and Drug Administration on the Release of Quality Management Standards for Medical Device Operations (2023 No. 153)," this directive signifies a significant step towards ensuring the safety and efficacy of medical devices utilized by the public.

The primary objective of Announcement No. 153 is to establish a framework for enhancing the quality management practices associated with medical device operations throughout the country. By introducing standardized procedures, the NMPA seeks to streamline processes, foster the development of industry-wide norms, and ultimately elevate the overall standards within the medical device sector.

The announcement emphasizes the importance of adhering to rigorous quality management protocols, which are essential for safeguarding public health and bolstering consumer confidence in medical devices. 

Key highlights of Announcement No. 153 include provisions for:

  1. Standardizing Procedures: The announcement outlines standardized procedures to be followed in various aspects of medical device operations, ranging from manufacturing and distribution to post-market surveillance and adverse event reporting.

  2. Industry-wide Collaboration: Recognizing the value of collaboration, the NMPA encourages stakeholders within the medical device industry to actively participate in the development of industry-wide standards. By fostering collaboration and knowledge sharing, the aim is to drive continuous improvement and innovation within the sector.

  3. Ensuring Safety and Effectiveness: Central to the directive is the overarching goal of ensuring the safety and effectiveness of medical devices utilized by the public. By establishing robust quality management standards, the NMPA aims to minimize risks associated with device usage and enhance overall patient care.

  4. Regulatory Compliance: Announcement No. 153 emphasizes the importance of regulatory compliance and urges stakeholders to align their operations with the prescribed standards. Adherence to regulatory requirements is crucial for maintaining product quality, meeting market demands, and upholding public trust.

For the full resource, please visit here (English translation available).