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NMPA published the “Implementation Rules for the Special Review of Innovative Medical Devices” on April 18, 2025. The document is based on the “Innovative Medical Devices Review Procedures” issued in
The NMPA granted innovation approvals to MediBeacon Inc.’s transdermal GFR measurement system (TGFR) and issued a review report. The published review reports like this one serve as important references for
The NMPA granted innovation approval to Roche’s Elecsys EBV VCA IgG and issued a review report on December 4, 2025. The published review reports like this one serve as important
The NMPA granted innovation approvals to CryoLife, Inc’s BioGlue Surgical Adhesive and issued a review report. The published review reports like this one serve as important references for you to
The NMPA granted Class II approvals to Roche’s Vitamin K Antagonist Self-Test, the combination of CoaguChek INRange and CoaguChek XS PT Test PST, and issued two review reports. The published
NMPA approved Medtronic’s Symplicity Spyral Renal Denervation System, the disposable multipolar renal artery radiofrequency ablation catheter and renal artery radiofrequency ablation device, according to a notice released on April 30,
NMPA published twelve review reports in January 2024 for innovation devices. Among them are two imported devices. These published review reports serve as important references for you to understand what
NMPA granted innovation approvals to seven devices in December 2023, for indications ranging from cardiovascular, orthopedic, immunology and urology. Among them are two imported devices. Complete List There have been
The NMPA issued the innovation approval review report for Varian’s Proton Therapy System. It is the seven imported innovative device approved by the NMPA so far in 2023, after Medtronic,
The NMPA granted innovation approval to Ischemic stroke CT image assisted assessment software and released the review report in July 2023. This software is designed to aid healthcare professionals in
On May 16, 2023, the NMPA granted innovation approval to Conavi Medical Inc., from Canada, for its intravascular imaging system. It is the fourth imported innovative device approved by the
The NMPA granted innovation approvals to seven devices in April 2023, for indications ranging from cardiovascular, orthopedic, neurology and ophthalmic. Among them are two imported devices. Complete List of Innovation