China NMPA Newsletter – May 2023

Featured Articles

NMPA New Approvals in May 2023

In May 2023, NMPA approved 175 medical devices, including 27 Class III imported products, 20 Class II imported products, and 128 Class III domestic products.

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

Medical Device/IVD	Manufacturer	Category
Light-curing flowable composite resin	株式会社松風	Class III
Chameleon PTA balloon catheter	Covidien llc	Class III
SlimPort™ M.R.I.™ Ultra Low-Profile Implantable Port	Bard Access Systems, Inc.	Class III
NobelProcera Angulated Screw Channel Abutment Zirconia	Nobel Biocare AB	Class III
Ultrasound Diagnostic Equipment	キヤノンメディカルシステムズ株式会社	Class III
GORE® VIABAHN® ENDOPROSTHESIS with Heparin Bioactive Surface	W. L. GORE & ASSOCIATES, INC.	Class III
DuraGen Plus® Dural Regeneration Matrix	Integra LifeSciences Corporation	Class III
Steroid Eluting, Bipolar, Implantable, Screw-in, Ventricular/Atrial, Transvenous Lead	Vitatron Holding B.V.	Class III
Aequalis Fracture System	Tornier SAS	Class III
Paclitaxel eluting PTA balloon catheter FREEWAY™035	Eurocor Tech GmbH	Class III
Arterial and Venous Cannula	Medtronic, Inc.	Class III
TECNIS Eyhance IOL	Johnson & Johnson Surgical Vision, Inc.	Class III
Y-Knot All-Suture Anchor	ConMed Corporation	Class III
Short Tip Digital IVUS Catheter	Volcano Corporation	Class III
iSR’obt Mona lisa	Biobot Surgical Pte Ltd	Class III
Novasight Hybrid System	Conavi Medical Inc.	Class III
Vitelene XPE Insert	Aesculap AG	Class III
Pressure Guide Wire	Volcano Corporation	Class III
Implantable Cardioverter/ Defibrillators	MicroPort CRM S.r.l.	Class III
Disposable Probes	inomed Medizintechnik GmbH	Class III
TANDEM Microspheres	Boston Scientific Corporation	Class III
AngioSculpt PTA Scoring Balloon Catheters	Spectranetics Corporation	Class III
Oral and maxillofacial cone beam computed tomography equipment	Osstem Implant Co., Ltd.	Class III
VENTANA HER2 Dual ISH DNA Probe Cocktail	Roche Diagnostics GmbH	Class III
INOmax DSIR Plus Delivery System	Mallinckrodt Manufacturing LLC	Class III
OsteoCool RF Ablation Electrode	Medtronic Sofamor Danek USA, Inc.	Class III
Disposable Vitrectome	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	Class III
Electronic Biliary Endoscope	富士フイルム株式会社	Class II
MRI Contrast media injector	Ulrich GmbH & Co.KG	Class II
LA Control	积水医疗株式会社	Class II
INTEGRATED DEVICE CORNEAL ANALYZER AND OCULAR BIOMETER	VISIA IMAGING S.r.l.	Class II
Proxyt Paste for professional tooth cleaning	Ivoclar Vivadent AG	Class II
Introducer Sheath	OSCOR INC.	Class II
Auditory analysis platform	PATH MEDICAL GmbH	Class II
Infusomat Plus Line	B.Braun Melsungen AG	Class II
Sterile Latex Examination Glove	HARTALEGA SDN. BHD.	Class II
Disposable Retractor	CooperSurgical, Inc.	Class II
Surgical Incision Negative Pressure Drainage Dressing Kit	KCI USA, Inc.	Class II
iSR’obt Biopsy Kit	Biobot Surgical Pte Ltd	Class II
Total Protein_2 (TP_2)	Siemens Healthcare Diagnostics Inc.	Class II
Lumipulse® G Pepsinogen II Calibrators	Fujirebio Inc.	Class II

NMPA Notice on the On-Site Inspection Guidelines of Enterprise Quality Management Specialized in Medical Device Transportation and Storage Services as Appendix for Medical Device Good Supply Practice

On May 24, 2023, NMPA releases new guidelines aimed at enhancing the supervision and management of medical device quality. These guidelines will standardize and provide guidelines for on-site inspections of enterprises specializing in medical device transportation and storage services.

China Releases Detailed Implementation Rules for Managing Human Genetic Resources

On June 1, 2023, the Ministry of Science and Technology of China has announced the issuance of the Detailed Implementation Rules for the Regulations on the Management of Human Genetic Resources. These rules were approved on May 11, 2023 and will be effective from July 1, 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.