China NMPA Newsletter – April 2023

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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.

NMPA New Plans on 118 Medical Device Registration Guidelines in 2023

NMPA Further Enhancing the Surveillance on Radiofrequency Beauty Devices

NMPA New Policy to Support China Real World Study

MORE ARTICLES

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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