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.
|iBrite Tooth Whitening Gel
|Disposable blunt end injection needle
|Feel Tech Co.,Ltd.
|Single use blood cell separator
|Terumo BCT Ltd.
|ARUM DENTISTRY Co., Ltd.
|VACUETTE®QUICKSHIELD Complete/Complete Plus
|Greiner Bio-One GmbH
|TrailBlazer Angled Support Catheter
|Siemens Healthcare GmbH
|Advanced Bionics AG
|Cayenne Suture Anchors
|Cayenne Medical, Inc.
|GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
|W.L. Gore & Associates, Inc.
|Xpert® HBV Viral Load
|Disposable high-frequency closed cutting surgical instrument
|Mammographic X-ray system
|GE MEDICAL SYSTEMS SCS
|Breast X-ray biopsy positioning system
|Free protein s determination kit (immunoturbidimetry)
|Disposable non absorbable closure clip
|META BIOMED CO.,LTD
|FluidiTube 2.7F Infusion Micro Catheter
|No knot anchor
|Smith & Nephew Inc., Endoscopy Division
|AXS Catalyst Distal Access Catheter
|Dental implant system
|Alpha-Bio Tec Ltd.
|Hip Joint Prostheses-Acetabular Liner
|Rigid breathable contact lens for corneal shaping
|Disposable nonabsorbable ligature clips
|CARDIAC POC Troponin T Control
|Roche Diagnostics GmbH
|X-ray flat panel detection system
|MEDRAD Centargo CT Injection System
|Imaxeon Pty Ltd
|BODY COMPOSITION ANALYZER
|SELVAS Healthcare, Inc.
|GIA Autosuture Universal Stapler
|Guiding instrument for intrauterine endoscopy
|AMNOTEC International Medical GmbH
|Surgical Instruments for Endoscope
|X-ray Tube Assembly
|FUJIFILM Healthcare Corporation
|RAPIDPoint® 500e Blood Gas System
|Siemens Healthcare Diagnostics Inc.
|Alanine aminotransferase aspartate aminotransferase complex assay dry tablets (rate method / rate method)
|Ortho-Clinical Diagnostics, Inc.
|Sterile balloon augmentation pressure pump
|Seawon Meditech Co., Ltd.
|Disposable endoscopic ultrasonic biopsy needle
|Dressing fluid-impermeable film
|SCHÖLLY FIBEROPTIC GMBH
|Fluorimetric immunoassay analyser（FIA）
|Boditech Med Inc.
|Fibrin (ogen) degradation product assay kit (immunoturbidimetry)
|B-type natriuretic peptide (BNP) assay kit
|Device for Quality Assurance of Radiation Therapy
|Standard Imaging, Inc.
|Single use ophthalmic scalpel
|Bone Grafting Material tool kits
|Zimmer Knee Creations
|Hydrocolloid waterproof band aid
|High sensitivity troponin I Assay Kit (microparticle chemiluminescent immunoassay)
|Siemens Healthcare Diagnostics Inc.
|Cold and hot therapeutic apparatus
|DeRoyal Industries, Inc.
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 email@example.com. We will help you submit your comments to NMPA before August 8, 2022.
Resources – 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.
- Overview of policies, regulations, and guidelines of RWE in China
- Usage of real world data for medical device life-cycle clinical evaluation including
- pre-market approval,
- post-market clinical research,
- conditional approval,
- indication changes, etc.
- Comparison of the usage of RWE in China and US
- How to plan and execute a real world study in the Hainan Tourism Pilot Zone
- Case Study: NMPA approvals with the support of real world evidence
Resources – NMPA FAQs