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/IVD
Manufacturer
Category
CharmCore Cement
Dentkist Inc.
Class III
iBrite Tooth Whitening Gel
Pac-Dent, Inc.
Class III
Disposable blunt end injection needle
Feel Tech Co.,Ltd.
Class III
Single use blood cell separator
Terumo BCT Ltd.
Class III
Custom Abutment
ARUM DENTISTRY Co., Ltd.
Class III
VACUETTE®QUICKSHIELD Complete/Complete Plus
Greiner Bio-One GmbH
Class III
Fluidfilter
東レ株式会社
Class III
TrailBlazer Angled Support Catheter
ev3, Inc.
Class III
MRI System
Siemens Healthcare GmbH
Class III
Cochlear Implant
Advanced Bionics AG
Class III
Cayenne Suture Anchors
Cayenne Medical, Inc.
Class III
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
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 info@bradyknowsmedical.com. We will help you submit your comments to NMPA before August 8, 2022.
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.
Agenda:
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
