In December 2023, NMPA
approved 343 medical devices, including 37 Class III imported products, 38 Class II imported products, and
266 Class III domestic products.
Below is a list of approved
Class III and Class II imported products in December 2023.
Medical Device/IVD
Manufacturer
Category
DG Reader Net
Diagnostic Grifols, S.A.
Class III
Implantable pacemakers
St. Jude Medical Cardiac Rhythm Management Division
Class III
Implantable Sacral Neurostimulation Lead
Medtronic Inc.
Class III
IV Filters
Pall Medical, a Division of Pall International Sàrl
Class III
Polydioxanone suture
Search Medical Co., Ltd.
Class III
Trimark Breast Tissue Marker
Hologic, Inc.
Class III
TRUSELECT Microcatheter
Boston Scientific Corporation
Class III
Modified Sodium Hyaluronate Gel for Injection with Lidocaine
YooYoung Pharmaceutical Co., Ltd.
Class III
MitraClip G4 Clip Delivery System
Abbott Medical
Class III
Coronary Intervention Control System
Robocath S.A.S
Class III
Implantable Cardioverter Defibrillator
Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation
On January 17th, the
NMPA approved the innovative product registration application for the Stomach Bypass Stent
System The product consists of a delivery system and a retrieval system. The delivery system
comprises a delivery device, stomach bypass stent, and guide wire, with the stomach bypass
stent pre-loaded into the delivery device’s storage tube. The retrieval system consists of a
retrieval tube, retrieval hook, and retrieval cap.
In a recent distinctive event, the Chinese Association of Plastic and
Aesthetic Physicians hosted a seminar on international collaboration in medical aesthetics, where industry
leaders and experts shared their insights.
On December 11, 2023, China NMPA’s Medical Device Technical Review Center
publicly solicited opinions on four guidelines for the registration review of medical devices. These include
clinical trial registration review guidelines for intracranial clot retrieval stent, extracorporeal membrane
oxygenation system, spring coil system of the same variety, and facial injection filling material.
A session on UK-China Medical
Device Access to China is scheduled for January 17, 2024, focusing on navigating the medical device
lifecycle and compliance in China. The agenda includes the introduction and launch of a report, an overview
of medical device regulation in China for UK SMEs, strategies to expedite premarket approvals, and insights
into post-market surveillance and compliance obligations. The session aims to provide information on key
regulations, approval processes, and best practices for UK medical device companies seeking access to the
Chinese market. The event will conclude with a Q&A session.
Session 2 on targeting unmet
medical needs in China’s growing market, features an agenda encompassing an introduction, an exploration of
the landscape of unmet medical needs in China, with a focus on areas where UK MedTechs can excel, discussion
of “Green Channels” for market access of UK medical devices to China, highlighting expedited pathways for
entry into the Chinese market, and concluding with a Q&A session.
Please
click here to review the record of BradyKnows webinar and short videos.
