NMPA New Approvals In August 2023


In August 2023, NMPA approved 288 medical devices, including 33 Class III imported products, 24 Class II imported products, and 229 Class III domestic products.

China NMPA is constantly upgrading regulations and guidelines for medical device regulatory, clinical affairs and post market surveillance in latest years. BradyKnows elite team has extensive experiences to support the whole life cycle of medical device. 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 August 2023.

Medical Device/IVDManufacturerCategory
Heart-Lung Support SystemMaquet Cardiopulmonary GmbHClass III
Novasight Hybrid CatheterConavi Medical Inc.Class III
MynxGrip Vascular Closure DevicesCardinal HealthClass III
Preloaded Intraocular LensHOYA Medical Singapore Pte. Ltd.Class III
3M Tegaderm Silicone Foam Dressing3M CompanyClass III
CPX4 PLUS Smooth Breast Tissue ExpandersMentorClass III
Aspheric Multifocal LensTeleon Surgical B.VClass III
Intraocular lensCarl Zeiss Meditec AGClass III
TightRopeArthrex, Inc.Class III
GlidePath™ Long-Term Hemodialysis CatheterBard Access Systems, Inc.Class III
High Flux DialyzerBellco S.r.l.Class III
Palindrome Precision H Chronic CatheterCovidien llcClass III
Blank CalRoche Diagnostics GmbHClass III
Ticron Coated Braided Polyester Nonabsorbable SutureCovidien llcClass III
FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.Class III
LIAISON XL murex HBsAg QuantDiaSorin Italia S.p.A.Class III
ORTHO Optix ReaderOrtho-Clinical DiagnosticsClass III
XVIVO Perfusion SystemXVIVO Perfusion ABClass III
IntraSight Integrated SystemVolcano CorporationClass III
Surgical Navigation SystemQuantum Surgical SASClass III
Comprehensive Reverse Shoulder SystemZimmer Inc.Class III
CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.Class III
Tigertriever Revascularization DeviceRapid Medical Ltd.Class III
HarmonizeKerr CorporationClass III
i-ED Coil株式会社カネカClass III
HOYA iSert Preloaded Intraocular LensHOYA Medical Singapore Pte. Ltd.Class III
Affixus Natural Nail Humeral Nail SystemZimmer GmbHClass III
ImplantNoris Medical Ltd.Class III
Free Protein SRoche Diagnostics GmbHClass III
Plasma HF-resection electrodesOlympus Winter & Ibe GmbHClass III
Semi-Automated External DefibrillatorPhysio-Control, Inc.Class III
Infuse Bone GraftMedtronic Sofamor Danek USA, Inc.Class III
ENSEAL X1 Tissue SealerEthicon Endo – Surgery, LLCClass III
Built-in ScalerE.M.S. Electro Medical Systems S.A.Class II
Ambulatory Blood Pressure RecorderSOMNOmedics GmbHClass II
Endoscopes of LaparoscopyKARL STORZ SE & Co. KGClass II
DD medical zirconia and accessoriesDental Direkt GmbHClass II
X-ray Tube Assemblies of Rotating AnodePhilips Medical Systems DMC GmbHClass II
Intraoral ScannerMEDIT Corp.Class II
Orthodontic bracketBIOCETEC Co., Ltd.Class II
ENT MR8 BursMedtronic Powered Surgical SolutionsClass II
VITA LUMEX ACVITA Zahnfabrik, H. Rauter GmbH & Co. KGClass II
CalSet AndrostenedioneRoche Diagnostics GmbHClass II
cobas GLU QC kitRoche Diagnostics GmbHClass II
cobas GLU linearity kitRoche Diagnostics GmbHClass II
3GEM ChemSTAT CVP 3Instrumentation Laboratory CompanyClass II
Electrically operated hospital bed with scalesLINET spol. s r.o.Class II
FX Assay Kit (Coagulation Method)Roche Diagnostics GmbHClass II
Porcelain Etch GelPulpdent CorporationClass II
Sterile Protective CoverJiangxi 3L Medical Products Group (Cambodia) Co., LtdClass II
FMS VUE II Fluid Management and Tissue Debridement SystemMedos International SARLClass II
FVII Assay Kit (Coagulation Method)Roche Diagnostics GmbHClass II
Image processing unitオリンパスメディカルシステムズ株式会社Class II
Cercon ht MLDeguDent GmbHClass II
Dental DrillsBiomet 3i, LLCClass II
Ultrasonic scalerSATELEC A Company of ACTEON GroupClass II
Sources: NMPA