China NMPA Newsletter – June 2022


Featured Articles

NMPA New Approvals In June 2022

In June 2022, NMPA approved 193 medical devices, including 26 Class III imported products, 25 Class II imported products, and 139 Class III domestic products.

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

Medical Device/IVDManufacturerCategory 
CharmCore CementDentkist Inc.Class III
iBrite Tooth Whitening GelPac-Dent, Inc.Class III
Disposable blunt end injection needleFeel Tech Co.,Ltd.Class III
Single use blood cell separatorTerumo BCT Ltd.Class III
Custom AbutmentARUM DENTISTRY Co., Ltd.Class III
VACUETTE®QUICKSHIELD Complete/Complete PlusGreiner Bio-One GmbHClass III
Fluidfilter東レ株式会社Class III
TrailBlazer Angled Support Catheterev3, Inc.Class III
MRI SystemSiemens Healthcare GmbHClass III
Cochlear ImplantAdvanced Bionics AGClass III
Cayenne Suture AnchorsCayenne Medical, Inc.Class III
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL SystemW.L. Gore & Associates, Inc.Class III
Xpert® HBV Viral LoadCepheid ABClass III
Disposable high-frequency closed cutting surgical instrumentCovidien llcClass III
Mammographic X-ray systemGE MEDICAL SYSTEMS SCSClass III
Breast X-ray biopsy positioning systemHologic, IncClass III
Free protein s determination kit (immunoturbidimetry)DIAGNOSTICA STAGOClass III
Disposable non absorbable closure clipMETA BIOMED CO.,LTDClass III
FluidiTube 2.7F Infusion Micro Catheterテルモ・クリニカルサプライ株式会社Class III
No knot anchorSmith & Nephew Inc., Endoscopy DivisionClass III
AXS Catalyst Distal Access CatheterStryker NeurovascularClass III
PTA CatheterCordis CashelClass III
Dental implant systemAlpha-Bio Tec Ltd.Class III
Hip Joint Prostheses-Acetabular LinerZimmer Inc.Class III
Rigid breathable contact lens for corneal shapingMenicon B.V.Class III
Disposable nonabsorbable ligature clipsTeleflex MedicalClass III
CARDIAC POC Troponin T ControlRoche Diagnostics GmbHClass II
X-ray flat panel detection systemキヤノン株式会社Class II
MEDRAD Centargo CT Injection SystemImaxeon Pty LtdClass II
GIA Autosuture Universal StaplerCovidien llcClass II
Guiding instrument for intrauterine endoscopyAMNOTEC International Medical GmbHClass II
Surgical Instruments for EndoscopeElliquence, LLC.Class II
X-ray Tube AssemblyFUJIFILM Healthcare CorporationClass II
RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.Class II
Alanine aminotransferase aspartate aminotransferase complex assay dry tablets (rate method / rate method)Ortho-Clinical Diagnostics, Inc.Class II
Spinal EndoscopeElliquence, LLC.Class II
Sterile balloon augmentation pressure pumpSeawon Meditech Co., Ltd.Class II
Disposable endoscopic ultrasonic biopsy needleオリンパスメディカルシステムズ株式会社Class II
Dressing fluid-impermeable filmHansBiomed Corp.Class II
power systemConMed CorporationClass II
Fluorimetric immunoassay analyser(FIA)Boditech Med Inc.Class II
Fibrin (ogen) degradation product assay kit (immunoturbidimetry)SYSMEX CORPORATIONClass II
B-type natriuretic peptide (BNP) assay kitTosoh CorporationClass II
Device for Quality Assurance of Radiation TherapyStandard Imaging, Inc.Class II
Single use ophthalmic scalpelマニー株式会社Class II
Bone Grafting Material tool kitsZimmer Knee CreationsClass II
Hydrocolloid waterproof band aid3M CompanyClass II
High sensitivity troponin I Assay Kit (microparticle chemiluminescent immunoassay)Siemens Healthcare Diagnostics Inc.Class II
Cold and hot therapeutic apparatusDeRoyal Industries, Inc.Class II

Sources: NMPA

NMPA Collects Public Comments On Adjusting Medical Device Clinical Evaluation Catalog and IVD Clinical Trial Exemption Catalog

On July 5, 2022, the NMPA issued a notice collecting public comments on the catalogues of medical devices exempted from clinical evaluation and IVD exempted from clinical trials.

NMPA released the Proposed New and Revised Catalogue of Medical Devices Exempted from Clinical Evaluation (2022 Draft for Comments). This new medical device catalog exempted from clinical evaluation includes neurological and cardiovascular surgery devices, medical diagnostic and monitoring devices,respiratory, anesthesia and first aid devices, blood transfusion, dialysis and extracorporeal circulation devices, passive implants instruments, ophthalmic devices, dental instruments and  the most modified category is infusion, nursing and protective devices.

It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical Catalog in the end. If you have any comments on the Clinical Evaluation/Clinical Trial Exemption Catalog, please contact We will help you submit your comments to NMPA before August 8, 2022.


Resources – Webinar

Medical Device Real World Evidence (RWE) In China: Policies, Usage, Study Plan, Case Study

Please click here to review the record of BradyKnows webinar.

Date: Wednesday, June 15, 2022, 7:00am-8:00am (US and Canada)

Wednesday, June 15, 2022, 4:00pm-5:00pm (Europe)

In 2019, the China National Medical Products Administration (NMPA) launched an RWE Pilot Program in Hainan, where locates the International Medical Tourism Pilot Zone and Free Trade Port. In 2020, NMPA released a guidance for the implementation of real world data to the clinical evaluation of medical devices. In the same year, NMPA approved a Glaucoma Treatment System, the first medical device that used the RWE generated in Hainan to support its initial registration.

Many medical device manufacturers regard China as an essential part of the global regulatory strategy of their products. However, few regulatory professionals are familiar with the policy, application, and generation of RWE in China and how to leverage RWE to support China market entry and potentially support the clinical evaluation work for other countries.

This webinar will discuss the policies and guidelines of RWE in China and use practical cases to illustrate how RWE is used to support life-cycle clinical evaluation, including pre-market approval, post-market clinical research, conditional approval, indication changes, long-term safety and efficacy assessment of medical devices, etc. This session will also cover the planning of RWE generation in China to support the manufacturer’s global clinical evaluation work.


Resources – NMPA FAQs

How To Write Periodic Risk Evaluation Report (PRER)

What Is The Qualification Requirement For Testing Labs For Non-clinical Research?

How To Define The “6-month” For Submission Of The Renewal