China NMPA Newsletter – May 2022


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NMPA New Approvals In May 2022

In May 2022, NMPA approved 164 medical devices, including 23 Class III imported products, 30 Class II imported products, and 109 Class III domestic products.

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

Medical Device/IVDManufacturerCategory
Shockwave Coronary Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.Class III
EnCor Breast Biopsy Probe with Rinse TubeSenoRx, Inc.Class III
HydroFill Embolic SystemMicroVention, Inc.Class III
Diacap Pro High Flux DialyzerB.Braun Avitum AGClass III
Lumipulse® Pepsinogen I/II ControlsFujirebio Inc.Class III
Transcatheter Leadless Pacing SystemMedtronic Inc.Class III
Guiding CatheterBalt Extrusion SASClass III
OptiBond SKerr CorporationClass III
Contour Ureteral StentBoston Scientific CorporationClass III
Flow Re-Direction Endoluminal Device SystemMicroVention,Inc.Class III
Shockwave Peripheral Intravascular Lithotripsy(IVL) CatheterShockwave Medical, Inc.Class III
Intravascular Lithotripsy Generator and Connector CableShockwave Medical, Inc.Class III
LithoVue Single-Use Digital Flexible UreteroscopeBoston Scientific CorporationClass III
LigaSureTM Retractable L-Hook Laparoscopic Sealer/DividerCovidien llcClass III
Hydrophilic Acrylic Intraocular LensRayner Intraocular Lenses LimitedClass III
Dragonfly OpStar Imaging CatheterAbbott MedicalClass III
Dental ImplantNobel Biocare ABClass III
Medical X-Ray Angiography SystemPhilips Medical Systems Nederland B.V.Class III
ORISE ProKnifeBoston Scientific CorporationClass III
Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.Class III
Laser SystemIRIDEX CorporationClass III
EEA Circular Stapler with Tri-Staple TechnologyCovidien llcClass II
Dental Carbide BursökoDENT-Preußer OHG Dental-medizinische PräzisionstechnikClass II
Instruments for CystoscopyAMNOTEC International Medical GmbHClass II
Stat Profile pHOx AnalyzerNova Biomedical CorporationClass II
L11 LED light source system with AIMStryker EndoscopyClass II
Gynaecological examination chairタカラメディカル株式会社Class II
FilterCovidien llcClass II
GuidewireBoston Scientific CorporationClass II
X-ray flat panel detector systemRayence Co.,Ltd.Class II
Surgical tablemedifa GmbH & Co.KGClass II
Liquid Chromatography – Mass Spectrometry SystemsWaters CorporationClass II
PreciControl Vitamin D total IIRoche Diagnostics GmbHClass II
Bicarbonate Standard FSDiaSys Diagnostic Systems GmbHClass II
VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Reagent PackOrtho-Clinical DiagnosticsClass II
InsufflatorW.O.M. WORLD OF MEDICINE GmbHClass II
Dental silicone rubber impression material株式会社ジーシーデンタルプロダクツClass II
ProgliderMaillefer Instruments Holding SàrlClass II
Lens Insertion DevicesBausch & Lomb, IncorporatedClass II
Easy pass guide wireMedi-Globe GmbHClass II
Porcelain pieceDeguDent GmbHClass II
IVF WorkstationCooperSurgical, Inc.Class II
Vitamin D totalRoche Diagnostics GmbHClass II
Urinary/Cerebrospinal Fluid Protein (UCFP)Siemens Healthcare Diagnostics Inc.Class II
Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics Products LimitedClass II
UVB PhototherapyClarteis SASClass II
SensorMasimo CorporationClass II
Wound CareSmith & Nephew Medical LimitedClass II
Dentine desensitizerAmerican Hi Teeth Science and Technology Inc.Class II

Sources: NMPA

Post-market Periodic Risk Evaluation Report Mandatory for License Holder in China

As per Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events, NMPA has regulatory requirements for Periodic Risk Evaluation Report (PRER) to enhance post-market surveillance.

The license holder shall:

PRER Report Contents:

  1. Product information
  2. Global market approval information, for each country where the product is approved
  3. Risk control measures taken by the regulatory authority or the manufacturer
  4. Adverse Event Reporting Information
  5. Other Risk Information
  6. Product Risk Evaluation
  7. Conclusions
  8. Attachments (NMPA certificate)

For full version of how to write PRER, please click Common FAQ | BradyKnows (

BradyKnows has experienced QA team to ensure your compliance in China market. Please feel free to reach out us for how to write and submit PRER via

For more questions related on localization, please feel free to reach out to BradyKnows via

Resources – NMPA FAQs-HGRAC