On April 4, NMPA releases the new plan for medical device registration guidelines in 2023 (NMPA, No. 6 of 2023) with the purpose to strengthen the guiding role of the review and guidelines for medical device registration in the processes of registration application and technical evaluation.
NMPA encourages relevant research institutions, industry associations, medical device manufacturing companies, and other entities to actively participate in the revision of the review and guidelines for medical device registration and to pay attention to any notifications or requests for comments regarding the compilation work of NMPA’s guidelines.
The plan includes detailed revisions for the review and guidance principles applicable to Class II and Class III medical devices, including 36 new guidelines for Class III medical devices, 27 revised guidelines for Class III medical devices, 23 new guidelines for Class II medical devices and 32 revised guidelines for Class II medical devices. The plan serves as a crucial document for stakeholders to understand and align their practices with the evolving regulatory landscape.
NMPA encourages all concerned parties to carefully review the plan and provide their valuable insights to contribute to the ongoing efforts in shaping the future of medical device registration processes.
With the release of the compilation plan, NMPA is taking proactive steps to strengthen the regulatory framework and promote a safer and more reliable medical device industry for the benefit of patients and healthcare providers alike.
For any questions on your product registration in China, please contact firstname.lastname@example.org.