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
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:
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 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 info@bradyknowsmedical.com if you need to know the
specifics .
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.
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.
