China NMPA Newsletter – February 2024


Featured Articles

NMPA New Approvals in January 2024

In January 2024, NMPA approved 321 medical devices, including 41 Class III imported products, 33 Class II imported products, and 247 Class III domestic products.

Below is a list of approved Class III and Class II imported products in January 2024.

Medical Device/IVD Manufacturer Category
Cross-linked sodium hyaluronate gel for injection NEW MEDIC CO., LTD. Class III
Disposable needle for endoscopy オリンパスメディカルシステムズ 株式会社 Class III
OCT Spinal Fixation System Medos International SARL Class III
FIBERGRAFT BG Morsels Bone Graft Substitute Prosidyan, Inc. Class III
SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation Class III
FastThread BioComposite Interference Screw Arthrex, Inc. Class III
LuxaBond Universal DMG Chemisch-Pharmazeutische Fabrik GmbH Class III
Disposable High-pressure Syringe and Accessories Imaxeon Pty Ltd Class III

Summary of 2023 China NMPA Medical Device Registration Work Report

NMPA has summarized its work on all medical devices in 2023, which includes medical device registrations, acceptance of applications for medical device registrations, and approvals of medical device registrations, as set out below:


China NMPA Released Plan For Annual Medical Device Quality Inspections

As the annual China NMPA medical device quality inspections gear up from March to April, lasting until the end of May. BradyKnows, as a licensed agent, takes proactive steps to ensure compliance and quality assurance for our clients.


China NMPA Released: Common Q&A for Medical Device Registrations in 2023

China NMPA has recently unveiled a comprehensive set of 71 Q&A addressing common issues encountered in the medical device registration process. The questions cover various aspects of the registration process, offering valuable insights and guidance. We translate the title of the question. please contact us via if you need to know the specifics .


China National Healthcare Security Administration Office Issues Notice on the Release of Medical Centralized Procurement Platform Service Standards (Version 1.0)

In line with the directives of the Central Committee and the State Council, and in accordance with the requirements outlined in the National Healthcare Security Administration’s Opinion on Improving and Enhancing the Functions of the Medical Centralized Procurement Platform to Support Pharmaceutical Price Reform and Management (Healthcare Security Document [2022] No.1), the National Healthcare Security Administration Office has developed and released the Medical Centralized Procurement Platform Service Standards (Version 1.0) on January 4, 2024. This standard is set to be implemented from July 1, 2024.

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