China NMPA Newsletter – October 2022


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NMPA New Approvals In October 2022

In October 2022, NMPA approved 204 medical devices, including 34 Class III imported products, 23 Class II imported products, and 146 Class III domestic products.

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

Medical Device/IVDManufacturerCategory
Light curing composite resin株式会社ジーシーデンタルプロダクツClass III
Palindrome Precision Chronic CatheterCovidien llcClass III
EMBOVAC Aspiration CatheterMedos International SARLClass III
Octrode Trial Lead KitSt.Jude MedicalClass III
Ophthalmic Surgical System Qube proFritz Ruck Ophthalmologische Systeme GmbHClass III
Coagulation controlsRoche Diagnostics GmbHClass III
Sensation Plus Intra-Aortic Balloon CathetersDatascope Corp.Class III
VITROS Immunodiagnostic Products HIV Combo ControlsOrtho-Clinical DiagnosticsClass III
Depth ElectrodePMT CorporationClass III
Corneal cross-linking systemIromed Group S.r.l.Class III
VISION EF Sensor-Ureterorenoscope and AccessoriesRichard Wolf GmbHClass III
Ultrasound Diagnostic EquipmentSAMSUNG MEDISON CO., LTD.Class III
Microwave therapeutics주식회사 한일티엠Class III
AMPLATZER Piccolo OccluderAbbott MedicalClass III
Radiopaque bone cement for Percutaneous Vertebral Augmentation (PVA) proceduresG21 S.r.l.Class III
Amplatzer TorqVue LP CatheterAbbott MedicalClass III
Sentinel Cerebral Protection SystemBoston Scientific CorporationClass III
Cross-linked Sodium Hyaluronate Gel for InjectionCG Bio Co., Ltd.Class III
TECNIS® Toric II 1-Piece IOLJohnson & Johnson Surgical Vision, Inc.Class III
Surpass Evolve Flow Diverter SystemStryker NeurovascularClass III
Theraputic plasma exchange tubingFresenius Medical Care AG & Co. KGaAClass III
Perclose ProStyle Suture-Mediated Closure and Repair SystemAbbott VascularClass III
Contact lens lubricantsSANTENClass III
Selective and Hyperselective CathetersBALT EXTRUSION SASClass III
EsBond Light Cured Bonding AgentSPIDENT Co., Ltd.Class III
Silicone Hydrogel Daily Color Contact LensVisco Technology Sdn. Bhd.Class III
LASSOSTAR Circular Mapping CatheterBiosense Webster, Inc.Class III
HemosIL Calibration PlasmaInstrumentation Laboratory CompanyClass III
WATCHMAN™ TruSealt™ Access SystemBoston Scientific CorporationClass III
Trident X3 EtO Acetabular InsertsHowmedica Osteonics Corp.Class III
Double-deck artificial dermal repair materialsグンゼ株式会社Class III
Freka Intestinal TubeFresenius Kabi AGClass III
Pump HeadsMedos Medizintechnik AGClass III
X-ray flat panel detectorキヤノン電子管デバイス株式会社Class II
Stat Profile Prime Plus MicroSensor CardNova Biomedical CorporationClass II
Endoscopic Camera SystemGIMMI GmbHClass II
Perfusion pumpBiosense Webster(Israel)Ltd.Class II
EV3.0 Camera Head & Sterile CoverAesculap AGClass II
Intense Pulsed Non-Coherent LightCyDen LtdClass II
Multichannel ElectrocardiographVyaire Medical GmbHClass II
Highspeed Surgical Drill Systemadeor Medical AGClass II
Vital Signs MonitorWelch Allyn, Inc.Class II
Mentor Resterilizable Gel Breast Implant SizerMentorClass II
Aqua Maris®Baby nasal spray/Aqua Maris®Clean nasal sprayJadran-Galenski laboratorij d.d.Class II
LATEX SURGICAL GlOVECareglove Global Sdn. Bhd.Class II
Dental implant drillsORNAGHI LUIGI & C.S.n.c.Class II
Shine LiquidGenoss Co., Ltd.Class II
IDS-iSYS 25 VitDSImmunodiagnostic Systems LimitedClass II
Beam scanning measurement system – dose measurement arrayPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHClass II
Laser systems for patient alignmentLAP GmbH Laser ApplikationenClass II
Intraoral Scanner SystemSirona Dental Systems GmbHClass II
Respiratory therapy deviceBreas Medical ABClass II
Lumipulse® G ProGRPFujirebio Inc.Class II
PreciControl Maternal CareRoche Diagnostics GmbHClass II
Orthopedic InstrumentsArthrex,Inc.Class II
Lava™ Plus3M Deutschland GmbHClass II

Sources: NMPA

Last Call For Testing & Modification Registration Of The GB 9706.1-2020 Standard Upgrade!

If your active medical device was approved by the China NMPA before 2021, most likely, you are not compliant with the newly upgraded Chinese national standard GB 9706.1-2020. 

Standard Upgrade 

Standard ID Name of Chinese Standard Referenced Standards Status 
GB 9706.1-2007 Medical electrical equipment — Part 1: General requirements for safety IEC 60601-2-3-2003, IDT To be revoked in 2023 
GB 9706.1-2020 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1:2012, MOD Starting from 5/1/2023 

The newly revised GB 9706.1-2020 Chinese standard will replace the GB 9706.1-2007 version. The newly upgraded GB 9706.1 standard is synchronized with the international standards IEC 60601-1:2012 (edition 3.1).  

Implementation Date 

At present, all seven parallel standards supporting GB9706.1-2020 have been released, and special standards are being released in batches. Regarding the implementation date of GB 9706.1-2020 and the supporting parallel standards, there are two key time points: 

Cited from “GB 9706.1-2020 and its supporting juxtaposition and special standard implementation rules (draft for comments)” 

For example, YY 9706.252-2021 standard (Medical electrical equipment — Part 2-52: Requirements for the basic safety and essential performance of medical beds) will be implemented on May 1, 2024, the implementation date of GB 9706.1-2020 for medical beds will be synchronized to May 1, 2024.  

Major Changes 

Compared with GB 9706.1-2007, the biggest change in the new version of the standard is the introduction of the concept of risk management, and the evaluation of basic performance is required. It is not enough to consider only basic safety, but also the basic performance of the product. A detailed comparison between the 2007 and 2020 version is available on request at  

Modification Registration 

For medical device manufacturers who have products approved in China, you need to implement the standard upgrade by its implementation date. You need to complete China local testing, obtain test reports and submit a modification registration to the NMPA for approval. If you fail to complete the modification registration before the deadline, you will not be able to continue your sales in China and your future renewal registration will be jeopardized.  

Considering the large difference between the 2020 version and 2007 version of the standard and the limited testing resources in China, to smoothly transition to the new version of the standard, it is recommended that you plan early and do adequate preparations.  

If you have not started the testing and modification registration process for the GB 9706.1-2020 standard upgrade, call BradyKnows for help.  

Initial Registration 

For manufacturers who have ongoing product initial registration in China, please check if your type testing is following the GB 9706.1-2020 version standard. If not, you may need to start a GB 9706.1-2020 testing in parallel to your existing registration to make sure that your newly approved product will be compliant with the upgraded standards. 

NMPA Notice on Adjustment of Technical Consultation about Medical Devices Registration before Application Acceptance

In order to comprehensively promote the development of China’s medical device industry and give full play to the technical support role of the medical device innovation service station for the development of medical device industry in the region, NMPA issued Notice on Adjustment of Technical Consultation about Medical Devices Registration before Application Acceptance (NMPA, No. 37, 2022) on October 16, 2022.

CMDE as the lead unit, responsible for the overall management and organization of the implementation of technical issues consulting work before registration acceptance. Drawing on the experience of the Yangtze River Delta Sub-Center for Devices and the Great Bay Sub-Center for Devices to carry out pre-registration technical issues consultation work, medical device innovation service stations in Sichuan Province, Jilin Province and Fujian Province, Beijing Municipal Medical Products Administration and Hainan Medical Products Administration are as a participating unit into the scope of pre-registration acceptance of technical issues consulting work.

The notice mainly describes the technical issues consultation before the acceptance of medical device registration, including on-site consultation time, on-site consultation location, consultation object and scope, consultation arrangements, consultation form, notes and contact information.

If you have any questions about Notice on Adjustment of Technical Consultation about Medical Devices Registration before Application Acceptance, please contact

The Third Batch of Medical Device Product Classification Identification in 2022

Center for Medical Device Standardization Administration, a branch of NMPA, issued a summary of the third batch of medical device product classification identification on October 27, 2022.

A total of 388 medical device product classification results have been summarized from July to September 2022, of which 45 products were suggested to be regulated as Class III medical devices, 149 products were suggested to be regulated as Class II medical devices, 98 products were suggested to be regulated as Class I medical devices, 75 products were suggested not to be regulated as medical devices, 4 products were suggested to be regulated as drug-device combination products, 2 products were suggested to be managed on the specific situation, and 15 products were suggested not to be regulated as medical devices alone.

If your products are not listed in the Medical Device Catalogue of NMPA, the application of category classification to NMPA is a good solution to identify the class of your device. We do highly recommend to map out your strategy to enter China before you kicks off the registration, including digging out the category of your device in China. Sometime, if your product is Class II in US, but it may be regulated as Class III in China.

BradyKnows elite team is very knowledgeable about the classification of medical device products, if you have any questions about this, please contact

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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