Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
China NMPA introduced a series of significant changes in medical device, IVD, companion diagnostic and combination products regulations in 2011. . With the implementation of decree Order 739, “Regulation on the Supervision and Administration of Medical Devices”, tens of new regulations and major updates in the forms of policies, guidelines, standards, and announcements were released in 2021. These updates and changes have impacted the complete product life cycle from new submissions, renewals to post market surveillance.
One giant leap from China medical device regulators—the NMPA began to recognize self-test report from manufacturers, with guidelines on the requirements and qualifications for self-test reports. New China CGP has been published adjusting the overall framework. Several clinical guidelines in CER, establishing equivalence, determining when to do clinical trial etc have been introduced. GMP as a new section requirement is added to the e-Filing catalogue.
With the sweeping changes, how can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, allow enough lead time for renewal as well as to know when to file for modifications to avoid penalties. Above all, how to stay compliant after your approval to meet China post market compliance as well hospital reimbursement code requirements.
Key updates include:
* Under Order 739: New law, regulation, policy, standards & guidelines
* New Perspective on Clinical Evaluation Pathways: clinical evaluation decision tree, overseas clinical data acceptance, clinical trial or not, piloted real-world data
* IVD & Combination Device
* Great Bay Area & Hainan Special Policy for NMPA Un-approved devices use in China
* PMS/QMS(NHSA code, AE, Recall & Overseas Inspection)
The session will cover the evolving regulations related to the main changes by China NMPA in support of its overarching policy, Order 739, “Regulation on the Supervision and Administration of Medical Devices”. It will review the impact on clinical evaluation pathways, clinical evaluation principles and processes, clinical evaluation reports and data appraisal, Good clinical practice (GCP) and Clinical trial permission (CTP). There have been significant updates as part of the continuous China NMPA regulatory transformation process.
This webcast will review Order 739 from China State Council which covers the complete product life cycle with a positive direction to more efficient and less burdensome approval process. Attend this live broadcast to learn the key highlights of clinical evaluation and clinical trial related changes and updates.
China’s regulations for medical technologies are undergoing a significant revision with implications for the entire product lifecycle. The new regulatory framework (Order 739 / Regulations for the Supervision and Administration of Medical Devices) went into effect on June 1, with several follow-on regulations to be issued in the coming months. This webinar will provide an in-depth overview of the key changes to product registration and post-market surveillance, helping your company to take advantage of new approval pathways and avoid possible penalties.
Event Link: Navigating China’s New Regulatory Policy: Order 739
Want to reduce your device’s clinical trial costs and accelerate its time to market in China? It’s possible when you use the latest China National Medical Products Administration (NMPA) regulatory developments to your advantage.
Now more than ever, NMPA’s regulatory approval process is going through transformational reform. Device makers — especially non-China manufacturers — have more options to supplement the traditional comprehensive clinical trial.
To keep up with international standards and help device manufacturers prepare for regulatory compliance, China’s National Medical Products Administration (NMPA) issued a number of regulations related to unique device identifiers (UDIs), and launched its new UDI database portal. The first group of medical devices, which includes high-risk implantable devices, is now mandated to submit UDI data to the database. In this webinar, you will get an overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements. Our experts will explain how they work in practice for UDI submission to NMPA and what to expect going forward.
Learn how the Hainan Real-World Data/Study (RWD/Study) pilot program can shave months off your timeline for initial clinical use of NMPA unapproved devices in a real-world setting. This initiative allows overseas medical devices, IVDs and drugs that have NOT been approved in China to be sold and used in real world clinical settings in Lecheng Hainan province and is particularly significant for overseas manufacturers with high-value and innovative devices that normally require clinical trials by China NMPA.
In this webcast you’ll receive guidance on how the program works, and the RWD/S in NMPA registration approval directly from Hainan officials. Tune in to learn if and how the program can accelerate your commercial sales and registration in China.
The China IVD market has seen record growth recently and will continue to be an important market with the growing threat of cancer and COVID-19. Join us on Thursday, July 23 from 11:00 a.m. – 12:00 p.m. EDT for the free webinar: China IVD Registration Pitfalls and COVID-19 Test Kit Updates. Attendees will receive comprehensive IVD guidance based on NMPA’s public training programs, as well as the latest guidance relating to COVID-19 test kits. Don’t miss this opportunity to learn more about NMPA’s requirements for IVD product registration!
Did you know China, the second-largest medical device and in vitro diagnostic (IVD) industry market globally, is the only market with a 20 percent annual growth rate year after year?
Are you up to speed on the hundreds of new regulations introduced by China’s National Medical Products Administration (NMPA) — formally known as the China Food and Drug Administration?
What are the strategic factors to consider during the reform before your submission?
As COVID-19 has become a pandemic, the time is critical for the support and reassurance that science can offer. In response to the outbreak, Chinese regulatory authorities adopted emergency measures to fast-track the review and approval process.
China NMPA (former CFDA) issued an unprecedented number of Emergency Approvals of medical devices, diagnostic assays, protective supplies, and sterilization tools. The first batch of diagnostic tests were approved within five days. Furthermore, multiple drugs and biologics are in a clinical trial and various stages of approval. One such example, Remdesivir — an antiviral drug that selectively inhibits the RNA-dependent RNA polymerase of the influenza virus — is a potential agent against COVID-19 and was approved within three days to enter a clinical trial.
Hundreds of new NMPA regulatory policies, guidelines, standards and announcements were released in 2019. These updates have a significant impact on new submissions, as well as approved and renewal products. This free webinar will provide an overview of the key NMPA changes and their implications on manufacturers.
Also for the first time in China, the piloted MAH system allows for the separation of the manufacturing entity from the product design entity for domestically manufactured devices. Likewise, more aggressive clinical regulations and the use of real world data will reduce the number of clinical trials. Attendees will learn how manufacturers or inventors can shorten their time to market for new submissions, allow enough lead time for renewal and when to file for modifications to avoid penalties.
Topics include:
• Standards & Guidelines
• Clinical Pathways: Overseas Clinical Data Acceptance & Piloted Real World Data
• MAH, UDI & eRPS
• SaMD & AI
• QMS (AE, Recall & Overseas Inspection)
Did you know China, the second-largest medical device and in vitro diagnostic (IVD) industry market globally, is the only market with a 20 percent annual growth rate year after year?
Are you up to speed on the hundreds of new regulations introduced by China’s National Medical Products Administration (NMPA) — formally known as the China Food and Drug Administration?
What are the strategic factors to consider during the reform before your submission?
During the webinar, you will:
This webinar will cover different clinical pathways and how to decide which pathway to choose to support NMPA (CFDA) medical device/IVD regulatory submission or post market surveillance. In addition to the traditional clinical evaluation report, we will go in-depth on the requirements for overseas clinical data acceptance and real world data/evidence in order to mitigate the clinical trial requirement. We will also cover key considerations on the feasibility and justification of overseas clinical data acceptance.
Finally, attendees will learn about the emerging use of Real World Data (RWD) being piloted in HaiNan, China – a cost-effective and less time-consuming alternative to the traditional clinical trial. Overseas manufacturers can obtain approval for the RWD pilot program through the Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval, significantly shortening the time to begin selling devices in China. Don’t miss out on the opportunity to learn more about this new policy! This informative webinar will provide you with:
