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2025 China NMPA Bluebook is here:
The NMPA published the “Key Points of Ultrasound Imaging Artificial Intelligence Software (Process Optimization)” on July 10, 2023, to direct related manufacturers for type testing, clinical evaluation, and regulatory submission.
The NMPA issued the “Draft Guideline on Modification Registration IVD of In Vitro Diagnostic Reagent” on May 31, 2023, for feedback. Feedbacks need to be submitted by June 30, 2023.
The last time the NMPA In Vitro Diagnostic Reagents Classification Catalog was announced was in 2013, with two supplemental updates in 2017 and 2020 respectively. NMPA issued the “Draft Classification
The NMPA issued seven IVDs draft guidelines on December 2, 2022, soliciting public opinions. Feedbacks need to be submitted by December 16, 2022. Draft Guideline on Submission Materials of Blood
The NMPA published an article on artificial intelligence software for process optimization, illustrating what the clinical applications of the software and how to do software validation. Artificial intelligence software for
The committee meeting of the China Artificial Intelligence Medical Device Innovation Cooperation Platform was held online on September 21, 2022. Focusing on bio-digital integration, experts and industry leaders discussed artificial
The NMPA issued the “Guideline on Instructions for Use of In Vitro Diagnostic Reagents (draft)” for feedback. The guideline stipulates drug information such as the intended use, test methods, interpretation
The article below is written by Liang Peng, AI expert and Deputy Minister of Evaluation Department I of CMDE (Center for Medical Device Evaluation) and Lei Sun, CMDE’s director, and
The NMPA released three guidelines in a single day, March 9, 2022 in an effort to regulate and support the rapid development in digital health: Guideline for Artificial Intelligence in
The NMPA released the “Registration Guideline on Combination Products with Device as Primary Mode of Action” on January 11, 2022, directing manufacturers for safety and efficacy evaluation of combination products.
The NMPA Standards Management Center published the “First Batch of Combination Products Classification Results in 2021” on July 7. Worth noted that overseas manufacturers pay more attention to the combination
Manufacturers have long been concerned that when applying for drug-device combination product registration, in addition to original country approval for the combination product, the submission of certificates of the drug,