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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/IVD | Manufacturer | Category |
| Shockwave Coronary Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | Class III |
| EnCor Breast Biopsy Probe with Rinse Tube | SenoRx, Inc. | Class III |
| HydroFill Embolic System | MicroVention, Inc. | Class III |
| Diacap Pro High Flux Dialyzer | B.Braun Avitum AG | Class III |
| Lumipulse® Pepsinogen I/II Controls | Fujirebio Inc. | Class III |
| Transcatheter Leadless Pacing System | Medtronic Inc. | Class III |
| Guiding Catheter | Balt Extrusion SAS | Class III |
| OptiBond S | Kerr Corporation | Class III |
| Contour Ureteral Stent | Boston Scientific Corporation | Class III |
| Flow Re-Direction Endoluminal Device System | MicroVention,Inc. | Class III |
| Shockwave Peripheral Intravascular Lithotripsy(IVL) Catheter | Shockwave Medical, Inc. | Class III |
| Intravascular Lithotripsy Generator and Connector Cable | Shockwave Medical, Inc. | Class III |
| LithoVue Single-Use Digital Flexible Ureteroscope | Boston Scientific Corporation | Class III |
| LigaSureTM Retractable L-Hook Laparoscopic Sealer/Divider | Covidien llc | Class III |
| Hydrophilic Acrylic Intraocular Lens | Rayner Intraocular Lenses Limited | Class III |
| Dragonfly OpStar Imaging Catheter | Abbott Medical | Class III |
| Dental Implant | Nobel Biocare AB | Class III |
| Medical X-Ray Angiography System | Philips Medical Systems Nederland B.V. | Class III |
| ORISE ProKnife | Boston Scientific Corporation | Class III |
| Coagpia ControlP-N | SEKISUI MEDICAL CO., LTD. | Class III |
| Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Class III |
| Laser System | IRIDEX Corporation | Class III |
| EEA Circular Stapler with Tri-Staple Technology | Covidien llc | Class II |
| Dental Carbide Burs | ökoDENT-Preußer OHG Dental-medizinische Präzisionstechnik | Class II |
| Instruments for Cystoscopy | AMNOTEC International Medical GmbH | Class II |
| SPY PORTABLE HANDHELD IMAGING (SPY-PHI) SYSTEM | Novadaq Technologies ULC | Class II |
| Stat Profile pHOx Analyzer | Nova Biomedical Corporation | Class II |
| L11 LED light source system with AIM | Stryker Endoscopy | Class II |
| Gynaecological examination chair | タカラメディカル株式会社 | Class II |
| Filter | Covidien llc | Class II |
| Guidewire | Boston Scientific Corporation | Class II |
| X-ray flat panel detector system | Rayence Co.,Ltd. | Class II |
| Surgical table | medifa GmbH & Co.KG | Class II |
| Liquid Chromatography – Mass Spectrometry Systems | Waters Corporation | Class II |
| PreciControl Vitamin D total II | Roche Diagnostics GmbH | Class II |
| Bicarbonate Standard FS | DiaSys Diagnostic Systems GmbH | Class II |
| VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Reagent Pack | Ortho-Clinical Diagnostics | Class II |
| Insufflator | W.O.M. WORLD OF MEDICINE GmbH | Class 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 |
| Proglider | Maillefer Instruments Holding Sàrl | Class II |
| Lens Insertion Devices | Bausch & Lomb, Incorporated | Class II |
| Easy pass guide wire | Medi-Globe GmbH | Class II |
| Porcelain piece | DeguDent GmbH | Class II |
| IVF Workstation | CooperSurgical, Inc. | Class II |
| Vitamin D total | Roche Diagnostics GmbH | Class II |
| Urinary/Cerebrospinal Fluid Protein (UCFP) | Siemens Healthcare Diagnostics Inc. | Class II |
| Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics Products Limited | Class II |
| SINGLE -USE OPTICAL FIBERS | Eufoton S.r.l. | Class II |
| UVB Phototherapy | Clarteis SAS | Class II |
| Sensor | Masimo Corporation | Class II |
| Wound Care | Smith & Nephew Medical Limited | Class II |
| Dentine desensitizer | American 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:
- conduct continuous research on the safety of certified medical devices
- summarize and analyze the adverse event reports
- monitoring data and domestic and foreign risk information of the product
- evaluate the risks and benefits of the product
- record the risk control measures taken
- write the post-market Periodic Risk Evaluation Report (PRER)
PRER Report Contents:
- Product information
- Global market approval information, for each country where the product is approved
- Risk control measures taken by the regulatory authority or the manufacturer
- Adverse Event Reporting Information
- Other Risk Information
- Product Risk Evaluation
- Conclusions
- Attachments (NMPA certificate)
For full version of how to write PRER, please click Common FAQ | BradyKnows (bradyknowsmedical.com).
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 info@bradyknowmedical.com
For more questions related on localization, please feel free to reach out to BradyKnows via info@bradyknowsmedical.com
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