China NMPA Newsletter – December 2022


Featured Articles

NMPA New Approvals in December 2022

In December 2022, NMPA approved 339 medical devices, including 37 Class III imported products, 25 Class II imported products, and 273 Class III domestic products. A total of 2,500 medical device products were approved by NMPA in 2022.

NMPA is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China.

Below is a list of approved Class III and Class II imported products in December, 2022.

Medical Device/IVDManufacturerCategory
Emprint™ Ablation System with Thermosphere™ TechnologyCovidien llcClass III
Single Photon Emission Computed Tomography SystemSpectrum Dynamics Medical Ltd.Class III
Insulin PumpSOOIL Development Co., LtdClass III
HIV Ag/Ab Combo (CHIV) AssaySiemens Healthcare Diagnostics Inc.Class III
Phacomeulsification/Vitrectomy system and accessoriesD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Class III
HemosIL Normal Control AssayedInstrumentation Laboratory CompanyClass III
Medical X-Ray angiography equipmentGE MEDICAL SYSTEMS SCSClass III
nGEN™ GeneratorBiosense Webster (Israel) Ltd.Class III
Disposable Syringe NeedleFeel Tech Co., Ltd.Class III
Prowler Select Plus Infusion CatheterMedos International SARLClass III
RapidVit™ Omni media for vitrificationVitrolife Sweden ABClass III
LifeStent 5F Vascular Stent SystemAngiomed GmbH & Co. Medizintechnik KGClass III
Ranger / Ranger SL Over-The-Wire Paclitaxel- Coated PTA Balloon CatheterHemoteq AGClass III
Microcoil SystemMedos International SARLClass III
Auxiliary articulation tubeAtos Medical ABClass III
Soft (Hydrophilic) Contact LensCooperVision Inc.Class III
AngioSculpt PTA Scoring Balloon CatheterSpectranetics CorporationClass III
Delta Xtend Reverse Shoulder SystemDePuy (Ireland)Class III
Angiographic CatheterANGIODYNAMICS,INC.Class III
Cordis Angiographic NeedleCordis CashelClass III
Multipurpose I.V.Connection SystemVYGONClass III
One-LinkBaxter Healthcare SAClass III
TECNIS Synergy OptiBlue Intraocular LensJohnson & Johnson Surgical Vision, Inc.Class III
CLYDESDALE PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.Class III
V.A.C.VERAFLO Dressing KitKCI USA, Inc.Class III
Cochlear ImplantsMED-EL Elektromedizinische Geräte GmbHClass III
Implantable PacemakerMedtronic Inc.Class III
Peripheral Coil SystemMicroVention,Inc.Class III
Infant radiation warming tableアトムメディカル株式会社Class III
Sterile pen needles for single useNovo Nordisk A/SClass III
Microcatheter Systemテルモ·クリニカルサプライ株式会社Class III
Lumipulse® HBcrAg ControlsFujirebio Inc.Class III
Cranial surgical navigation and positioning systemMedtronic Navigation, Inc.Class III
cobas® Buffer Negative Control KitRoche Diagnostics GmbHClass III
TrapLiner catheterVascular Solutions LLCClass III
Teeth Whitening GelNanova Biomaterials, Inc.Class III
Response Reader Advanced SystemResponse Biomedical CorporationClass II
Valleylab Smoke Evacuation Rocker Switch PencilCovidien llcClass II
OMNI II ProgrammerImpulse Dynamics (USA), Inc.Class II
Flexible Video-Cystoskop HDKARL STORZ SE & Co.KGClass II
Calibrator sTfR IIRoche Diagnostics GmbHClass II
Seramun SpotSight® plate monoSeramun Diagnostica GmbHClass II
Amber Mill Blocks & DisksHASS CORPORATIONClass II
Dissecting ToolsMedtronic Powered Surgical SolutionsClass II
The Electric Stealth-Midas MR8 SystemMedtronic Powered Surgical SolutionsClass II
Implant Handpiece-Contra-angleKaVo Dental GmbHClass II
Audio ProcessorMED-EL Elektromedizinische Geräte GmbHClass II
Laser systems for patient alignmentLAP GmbH Laser ApplikationenClass II
LIAISON® XSDiaSorin S.p.A.Class II
X-ray flat panel detectorキヤノン電子管デバイス株式会社Class II
Mammography X-ray unitPlanmed OyClass II
EmbryoScope FlexVitrolife A/SClass II
EmbryoScope FlexVitrolife A/SClass II
Patient ProgrammerMedtronic Inc.Class II
Patient TableDornier MedTech GmbHClass II
BIS Extend sensorCovidien llcClass II
Portable X-ray systemOsstem Implant Co., Ltd.Class II
McGRATH MAC Video LaryngoscopeAircraft Medical LimitedClass II
eG1 Cutting TipsThe Anspach Effort, Inc.Class II
aTgII Quality Control (aTgII QC)Siemens Healthcare Diagnostics Products LimitedClass II


NMPA Adjusting Registration Application Payment Terms 

NMPA issued a notice on the deferment of payment of registration review fees for drugs and medical device products (No. 81 of 2022) on September 29, 2022.

The main contents are as follows:


NMPA Encouraging Enterprises to Lead Standard Drafting

According to the work deployment of the NMPA, the Center for Medical Device Standardization Administration NMPA has drafted the “Enterprise Led Drafting of Recommended Industry Standards for Medical Devices (Trial)” under the framework of the “Medical Device Standardization and Revision Management” to regulate the drafting of recommended industry standards for medical devices by enterprises. With the approval of the NMPA, the draft for comment is now available for public comment as required.

This is the description of the new and old standard system given by the National Standards Commission when the group standard came out in 2018, that is, the recommended industry standard should be dominated by the government.


NMPA Collects Public Comments On Guidelines for Registration Review of Implantable Medical Device Battery

In order to standardize the requirements for technical review and guide the registration and application of enterprises, CMDE has organized the drafting of the Guidelines for Registration Review of Implantable Medical Device Battery (Draft for Comments), which will solicit comments from now on.

Scope Of Application

These guidelines apply to implantable medical device batteries, for other medical device batteries also have some reference significance, including but not limited to lithium-ion batteries, nickel-metal hydride batteries, nickel-cadmium batteries, lead batteries, dry cells and other chemical batteries, photovoltaic batteries and other physical batteries, flexible batteries and other new batteries.


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

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