China NMPA Newsletter – January 2024


Featured Articles

NMPA New Approvals in December 2023

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 Class III

Approval Granted for Stomach Bypass Stent System to Hit the Market

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.

Featured News-Medical Aesthetics

Globalization Wave Sweeps Medical Aesthetics, Emerging Signs of Asia-Pacific Medical Aesthetics Community

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.

Opinions on the Review of Clinical Registration of “Facial Injectable Filler”

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.

Resources – Webinar/Short Videos

UK-China Medical Device Access to China

Session 1 -Navigating Medical Device Lifecycle and Compliance in China

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-Targeting Unmet Medical Needs in China’s Growing Market

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.

  • Revisiting Order 739
  • Order 739
  • Clinical Evaluation
  • Respiratory Registration
  • China GMP/GSP/NMPA Onsite Inspections
Resources – Documents Download
  • NMPA Regulation
  • Guideline & Standard
  • Clinical Evaluation
  • AE & Recall