NMPA New Approvals In April 2022

2022-06-21

In April 2022, NMPA approved 212 medical devices, including 35 Class III imported products, 20 Class II imported products, and 154 Class III domestic products.

NMPA is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Below is a list of approved Class III and Class II imported products in April, 2022.

Medical Device/IVD	Manufacturer	Category
Hydrophilic-coated intravascular angiography catheter	Terumo	Class III
Ticron Coated Braided Polyester Nonabsorbable Suture	Covidien llc	Class III
Safari²™ Guidewires	Lake Region Medical	Class III
Healix Advance SP PEEK Anchor	Medos International SARL	Class III
LUCENCE	TEKNIMED S.A.S	Class III
Vantage Galan 3T MRT-3020	Canon	Class III
Peripheral Coil System	MicroVention,Inc.	Class III
Laparoscopic high-frequency surgical instruments	GIMMI GmbH	Class III
Implantable Cardioverter/Defibrillators	MicroPort CRM S.r.l.	Class III
Stellant Flex Disposable Kit	Bayer Medical Care Inc.	Class III
SCENARIA View	Fuji Film	Class III
Dermalax Deep	ACROSS CO., LTD.	Class III
Collagen-based dental bone filling material	GENOSS Co., Ltd.	Class III
Triathlon Tritanium Knee System	Howmedica Osteonics Corp.	Class III
True Form Reshapable Guide Wire	Merit Medical Systems, Inc.	Class III
Tubing systems for Continuous Blood purification	Fresenius Medical Care AG & Co. KGaA	Class III
GO2 Steerable Guide Wire System	Merit Medical Systems,Inc.	Class III
Disposable blunt tip needle	(주)제일테크	Class III
HydroSoft 3D Embolic System	MicroVention, Inc.	Class III
INDIGO Aspiration System	Penumbra, Inc.	Class III
Fresenius HD-Tubing systems	Fresenius Medical Care AG & Co. KGaA	Class III
Tubing Systems for Continuous Blood Purification	Fresenius Medical Care AG & Co. KGaA	Class III
Orthophos S 3D	Sirona Dental Systems GmbH	Class III
Resectoscope accessories	STEMA Medizintechnik GmbH	Class III
Hemodynamic and Electrophysiological Recording System	Siemens Healthcare GmbH	Class III
20223130205	NeoTract, Inc.	Class III
Dental Implant	Nobel Biocare AB	Class III
CD HORIZON Spinal System	Medtronic Sofamor Danek USA, Inc.	Class III
ACUVUE® VITA™ Brand Contact Lenses for ASTIGMATISM	Johnson & Johnson Vision Care,Inc.	Class III
Fracture and Correction System	In2Bones USA	Class III
ABT12 multi-purpose solution	Bausch & Lomb Incorporated	Class III
Resection endoscopes and accessories	GIMMI GmbH	Class III
Ultrasound Diagnostic Equipment	SAMSUNG MEDISON CO., LTD.	Class III
Aptima HIV-1 Quant Dx Assay	Hologic, Inc.	Class III
Lumipulse® G Pepsinogen II	Fujirebio Inc.	Class III
Erythropoietin (EPO) Quality Control	Siemens Healthcare Diagnostics Inc.	Class II
Lumipulse® ProGRP Controls	Fujirebio Inc.	Class II
3D OCT-1 Maestro2	Topcon	Class II
Ambu aView Monitor	Ambu A/S	Class II
Total Bile Acids	SENTINEL CH. S.p.A.	Class II
Therapy Monitor	Fresenius Medical Care AG & Co. KGaA	Class II
Rifampicin Susceptibility Test Disc	Oxoid Limited	Class II
Amoxycillin/Clavulanic Acid Susceptibility Test Disc	Oxoid Limited	Class II
Surgical Microscope	Leica Microsystems (Schweiz) AG	Class II
Vitamin D total II CalSet	Roche Diagnostics GmbH	Class II
CONTOUR CARE blood glucose meter	Ascensia Diabetes Care Holdings AG	Class II
EUROArrayScanner	EUROIMMUN Medizinische Labordiagnostika AG	Class II
Acrobat® 2 Calibrated Tip Wire Guide	Wilson-Cook Medical, Inc.	Class II
Primescan AC	Sirona Dental Systems GmbH	Class II
Androstenedione (ANDRO)	Siemens Healthcare Diagnostics Inc.	Class II
P-FDP CALIBRATOR	SYSMEX CORPORATION	Class II
D-Dimer CALIBRATOR NEO	SYSMEX CORPORATION	Class II
LIASAUTO CONTROL	SYSMEX CORPORATION	Class II
The F1 Battery Powered Micro system	Stryker Instruments	Class II
SpyScope DS II Access and Delivery Catheter	Boston Scientific Corporation	Class II

NMPA New Approvals In April 2022

In April 2022, NMPA approved 212 medical devices, including 35 Class III imported products, 20 Class II imported products, and 154 Class III domestic products.

Below is a list of approved Class III and Class II imported products in April, 2022.

Sources: NMPA