China NMPA Newsletter – March 2024

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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.

China NMPA Newsletter – March 2024

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