China NMPA Newsletter – April 2023


Featured Articles

NMPA New Approvals in April 2023

In March 2023, NMPA approved 290 medical devices, including 33 Class III imported products, 26 Class II imported products, and 227 Class III domestic products.

Below is a list of approved Class III and Class II imported products in March 2023.

Medical Device/IVD Manufacturer Category
COLTRIX CartiRegen Ubiosis Co., Ltd Class III
Signia Small Diameter Reloads Covidien llc Class III
Functional Neurosurgery Electrophysiology Recording System Alpha Omega Engineering Ltd. Class III
CR-type catheter F Care Systems NV Class III
Persona Partial Knee System Biomet Orthopedics Class III
TECNIS® 1-Piece IOL with TECNIS Simplicity™ Delivery System Johnson & Johnson Surgical Vision, Inc. Class III
Pulsar-18 T3 Peripheral Self-expanding Nitinol Stent System BIOTRONIK AG Class III
Elecsys PIVKA-II Roche Diagnostics GmbH Class III
AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL) Alcon Laboratories, Incorporated Class III
Aperio Hybrid Thrombectomy Device Acandis GmbH Class III
CONDUIT™ Interbody Cages Emerging Implant Technologies GmbH Class III
Prismaflex TPE Set Gambro Industries Class III
A-Viearchee SCL CO.,LTD. Class III
Biatain Silicone Non-Border Foam Dressing Coloplast A/S Class III
Nautilus Smart ECMO Module MC3 Inc. Class III
3D printed Redapt Modular Acetabular System Smith & Nephew, Inc. Class III
Compression Screw Arthrex, Inc. Class III
Dental Implants APEIRON DENTAL S.r.l. Class III
Comprehensive Fracture Shoulder System Biomet Orthopedics Class III
PICO 14 Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Class III
Safety Pen Needle Owen Mumford Limited Class III
ControlSet sTfR II Roche Diagnostics GmbH Class II
HITACHI ISE CONTROL (LIQUID) Hitachi High-Tech Corporation Class II
Proxeo TWIST Polishing System W&H Dentalwerk Bürmoos GmbH Class II
VITROS XT Chemistry Products UREA-CREA Slides Ortho-Clinical Diagnostics, Inc. Class II
Pulse Oximeter Masimo Corporation Class II
Extraction Balloon Catheter ゼオンメディカル株式会社 Class II
Sterile sea water in vials for nasal cavities cleansing LABORATOIRE UNITHER Class II
directCheck Normal Controls-ACT Accriva Diagnostics, Inc. Class II
LDL Cholesterol Siemens Healthcare Diagnostics Inc. Class II
LDL Cholesterol Calibrator Siemens Healthcare Diagnostics Inc. Class II
Amylase_2 (AMY_2) Siemens Healthcare Diagnostics Inc. Class II
Small Bone Cutting Accessories Stryker Instruments Class II
EsTemp NE Non-Eugenol Temporary Cement SPIDENT Co., Ltd. Class II
LMA UniqueTM (Silicone Cuff)&LMA UniqueTM (Silicone Cuff) Cuff PilotTM Teleflex Medical Class II
Active-B12 (Holotranscobalamin) (AB12) Siemens Healthcare Diagnostics Inc. Class II
Ureteroscope & Accessories Olympus Winter & Ibe GmbH Class II
Single Use Sterile Optical Fiber G.N.S neoLaser Ltd. Class II
Manual Wheelchair RGK Wheelchairs Ltd. Class II
Shockwave therapy device (주)웨버인스트루먼트 Class II
Flip Cutter III T.A.G. Medical Products Corporation Ltd. Class II

NMPA Onsite Inspection on Manufacturers or Legal Agent without Submitting Annual Quality System Self-Inspection Report Since April 2023

For manufacturers operating medical devices in China, NMPA has issued the deadline for submitting the 2022 Annual Quality System Self-Inspection Report to China’s provincial level NMPA on March 31st, 2023.


New China CER Website

The new website was built based on the newly updated clinical evaluation requirements and regulation in China under the Order 739.

We are here to help you obtain China market approval for your medical devices with a comprehensive Clinical Evaluation Report (CER). Before jumping to any conclusions, use our newly developed tool for a CER FEASIBILITY SELF-EVALUATION.



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