China NMPA Newsletter – November 2023

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NMPA New Approvals in November 2023

In November 2023, NMPA approved 301 medical devices, including 34 Class III imported products, 39 Class II imported products, and 226 Class III domestic products.

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

Medical Device/IVD	Manufacturer	Category
Proton Therapy System	Varian Medical Systems Particle Therapy GmbH & Co. KG	Class III
Amplatzer Talisman PFO Occluder	Abbott Medical	Class III
Amplatzer Talisman Delivery Sheath	Abbott Medical	Class III
CONTACT LENSES	Supervision Optimax Sdn Bhd	Class III
Arctic Sperm Cryopreservation Medium	FUJIFILM Irvine Scientific， Inc.	Class III
Anchored balloon dilatation catheter	株式会社カネカ	Class III
Dual-curing bonding resin watermend	Tokuyama Dental Corporation	Class III
SU-POR Patient-Specific Surgical Implant	Poriferous， LLC	Class III
Sterile Silicone Breast Implants Motiva Implant Matrix	Establishment Labs S.A.	Class III
ProTi360°Interbody System	Tyber Medical， LLC	Class III
MP Monoblock Hip Prosthesis Stem	Waldemar Link GmbH & Co. KG	Class III
ROTAPRO Rotational Atherectomy System	Boston Scientific Corporation	Class III
Diagnostic Ultrasound System	GE Healthcare Austria GmbH & Co OG	Class III
ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device	Boston Scientific Corporation	Class III
SPECT/CT	Spectrum Dynamics Medical Ltd.	Class III
Precision1 for Astigmatism soft contact lenses	Alcon Laboratories， Inc.	Class III
Clareon PanOptix Trifocal Hydrophobic IOL	Alcon Laboratories， Incorporated	Class III
Continuous Single Culture® Complete (CSCM-C)	FUJIFILM Irvine Scientific， Inc.	Class III
Soft Tissue Implants Visco-elastic gel of hyaluronic acid – with lidocaine	Laboratoires Fill-Med Manufacturing S.A.	Class III
pORTAL Steerable Hydrophilic Guidewire	phenox GmbH	Class III
AngioSculpt PTCA Scoring Balloon Catheter， Rapid Exchange (RX)	Philips Image Guided Therapy Corporation	Class III
ACTIS DuoFix Hip Prosthesis	DePuy (Ireland)	Class III
ETHIBOND Excel Polyester Suture with Pledget	Ethicon， LLC	Class III
3M Tegaderm High Performance Foam Non-Adhesive Dressing	3M Company	Class III
BIOCLEN O2 SEPT	OPHTECS CORPORATION	Class III
PEEK Suture Anchor	Arthrex， Inc.	Class III
ETHIBOND Excel Polyester Suture with Pledget	Ethicon， LLC	Class III
Continuous Glucose Monitoring System	Abbott Diabetes Care Ltd.	Class III
SpaceStation and SpaceCom	B. Braun Melsungen AG	Class III
StarWalker	Fotona d.o.o.	Class III
cobas® 5800 Instrument	Roche Molecular Systems， Inc.	Class III
Patient monitor	GE Medical Systems Information Technologies， Inc.	Class III
RGP ASPHERIC Lens	Fitlens Ltd	Class III
Steerable guiding sheath	Oscor Inc.	Class III
Accu-Chek Guide Link blood glucose meter	Roche Diabetes Care GmbH	Class II
Free Beta Human Chorionic Gonadotropin (FBHCG)	Siemens Healthcare Diagnostics Inc.	Class II
Pulse CO-Oximeter	Masimo Corporation	Class II
Medical Images Processing Software	Siemens Healthcare GmbH	Class II
Pregnancy-Associated Plasma Protein-A (PAPP-A)	Siemens Healthcare Diagnostics Inc.	Class II
Haptoglobin assay kit (Immunoturbidimetric method)	Siemens Healthcare Diagnostics Inc.	Class II
Liquichek Immunology Control	Bio-Rad Laboratories， Inc.	Class II
Squamous Cell Carcinoma Calibrator (SCC CAL)	Siemens Healthcare Diagnostics Inc.	Class II
N Protein Standard UY	Siemens Healthcare Diagnostics Products GmbH	Class II
Uriflet S 11UA	ARKRAY Factory， Inc.	Class II
Video Duodenoscope	HOYA株式会社	Class II
Ophthalmoscope Fundus Camera	CenterVue S.p.A.	Class II
Uro-3500 Display Handle Kit	UroViu Corporation	Class II
Flexible Endoscope， Single-use	Ambu A/S	Class II
Disposable biopsy forceps	オリンパスメディカルシステムズ株式会社	Class II
CEREC Tessera	DeguDent GmbH	Class II
Attachments	bredent GmbH & Co. KG	Class II
DAMON ULTIMA ARCHWIRES	Ormco Corporation	Class II
Transnasal Feeding Tube	Fresenius Kabi AG	Class II
DAMON ULTIMA ARCHWIRES	Ormco Corporation	Class II
Surgical Instrument Kit	MegaGen Implant Co.，Ltd.	Class II
Electric Traction Chair	オージー技研株式会社	Class II
SleepImage System	MyCardio LLC	Class II
Autophoropter	ESSILOR INTERNATIONAL	Class II
Diagnostic Ultrasound System	GE Vingmed Ultrasound A/S	Class II
Cholinesterase assay kit (butyrylthiocholine substrate method)	Siemens Healthcare Diagnostics Inc.	Class II
Battery Power Supply Surgical Equipment for Osseous Tissue	Synthes GmbH	Class II
CalSet FT4 IV	Roche Diagnostics GmbH	Class II
Attachments	bredent GmbH & Co. KG	Class II
Dental Zirconia Porcelain Powder	株式会社松風	Class II
Bright Impress	Genoss Co.， Ltd.	Class II
Kangaroo Connect Enteral Feeding Sets	Covidien llc	Class II
Surgipro II Monofilament Polypropylene Nonabsorbable Suture with CARDIOPOINT Cardiovascular Needles	Covidien llc	Class II
Condensation Silicones for Dental Impression	ZHERMACK S.p.A	Class II
Lupus S	Roche Diagnostics GmbH	Class II
FLUID CONTROL 2225	Richard Wolf GmbH	Class II
Acid Oxidation Potential Water Generator	アマノ株式会社	Class II
myoelectric evoked potentials (EMG)	日本光電工業株式会社	Class II
Comprehensive Dental Treatment Machines	Dentium Co.， Ltd.	Class II

China’s State Council Approves Blueprint for Beijing’s National Service Industry Pilot Zone

In a monumental decision, China’s State Council has officially given the nod to the ambitious plan for constructing the National Service Industry Pilot Zone in Beijing on November 23, 2023. The document charts a course to deepen the development of the national service industry and enhance its global openness—a move that BradyKnows Medical recognizes as a significant leap forward.

China Approves Innovative Single-Port Laparoscopic Surgery System

On November 24, 2023, the NMPA granted approval for the innovative “Single-Incision Laparoscopic Surgery System.

Resources – Webinar/Short Videos

Resources – New Documents Download

Guidelines For The Use Of Real-World Data In Clinical Evaluation Of Medical Devices-Trial(Nov 24, 2020)

China NMPA Newsletter – November 2023

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