China NMPA Newsletter – March 2024


Featured Articles

NMPA New Approvals in February 2024

In February 2024, NMPA approved 193 medical devices, including 21 Class III imported products, 22 Class II imported products, and 148 Class III domestic products.

Below is a list of approved Class III and Class II imported products in February 2024.

Medical Device/IVD Manufacturer Category
GentleMax Pro Plus Candela Corporation Class III
Composite QC level 2 東ソー株式会社 Class III
X-ray computed tomography equipment GEヘルスケア・ジャパン株式会社 Class III
External Ventricular DrainageEconomic HP BIOPROTESES LTDA Class III
ACUVUE OASYS MAX 1-DAY Contact Lenses Johnson & Johnson Vision Care, Inc. Class III
PTCA guidewire 朝日インテック株式会社 Class III
Preloaded Intraocular Lens HOYA Medical Singapore Pte. Ltd. Class III
Target Detachable Coils Stryker Neurovascular Class III
Orsiro Mission Sirolimus Eluting Coronary Stent System BIOTRONIK AG Class III
Trabecular Metal Reverse Plus Shoulder System Zimmer Inc. Class III
MicroCatheter 株式会社カネカ Class III
Double WireTM and Single Wire Sternum Suture A&E Medical Corporation Class III

Disposable Cardiac Pulse Field Ablation Catheter Approved By China NMPA

NMPA has summarized its work on all medical devices in 2023, which includes medical device registrations, acceptance of applications for medical device registrations, and approvals of medical device registrations, as set out below:


CT Angiography Software For Intracranial Aneurysm Detection Approved By China NMPA

As the annual China NMPA medical device quality inspections gear up from March to April, lasting until the end of May. BradyKnows, as a licensed agent, takes proactive steps to ensure compliance and quality assurance for our clients.