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China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739October 28, 2021

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.

  • Understand the new framework and key clinical evaluation changes for writing CER with the implementation of Order 736
  • Learn to use more versatile clinical evidence to support clinical evaluation and fast approval pathways for urgent use/innovation
  • Learn how to conduct clinical evaluations and how to prepare clinical evaluation reports
  • Understand how to demonstrate equivalence
  • Learn methods for determining if clinical trials are necessary

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Navigating China's New Regulatory Policy: Order 739June 28, 2021

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.

  • Grasp the key content of Order 739 and its changes across the entire product lifecycle.
  • Glean the most significant benefits for multinational corporation manufacturers, such as NMPA’s acceptance of a self-test report or third-party test reports; the establishment of special geographic regions within China where non-approved devices can be used, etc.
  • Discover how clinical evidence can be leveraged in more versatile ways to support clinical evaluation.
  • Become familiar with fast-track approval pathways for cutting-edge innovations and products intended for emergency use.
  • Learn how to avoid penalties as post-market monitoring will become more stringent.

Event Link: Navigating China’s New Regulatory Policy: Order 739


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2021 New Updates: China NMPA Medical Device Clinical PathwaysJanuary 27, 2021

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.


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Learn to Comply With China's UDI Submissions RequirementsDecember 8, 2020

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.


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Fast-Track Your Initial Clinical Use with the Hainan RWD/S Pilot ProgramDecember 2, 2020

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.


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China IVD Registration Pitfalls and COVID-19 Test Kit UpdatesAugust 17, 2020

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!


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China Mandatory Period Risk Evaluation Report and the latest PMS Requirements in NMPA and FDAJuly 9, 2020

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?


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Implications to Life Science Companies Relating to COVID-19April 8, 2020

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.


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2019 NMPA Key Updates & Trends: Look Ahead to 2020January 27, 2020

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)


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China NMPA Latest Regulatory Updates with PMS QMS FocusJanuary 23, 2020

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:

  •  Determine how to leverage a legal agent in China to increase your compliance by understanding their roles and responsibilities
  • Discover how to assess and determine the new piloted MAH system by understanding its MAH qualification requirements and responsibilities
  • Familiarize yourself with how to leverage your overseas QMS for your China operations by understanding China GMP regulations and Chinese culture differences
  • Find out how to comply with required adverse events (AE) and serious adverse events (SAE) reports, including how to differentiate between AE and SAE and when to report

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Developments in Clinical Pathways for NMPA (CFDA) SubmissionDecember 2, 2019

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:

  • Key factors for China clinical strategy and pathways to support submission
  • Main differences in China CER and EU CER
  • Key factors to consider in using overseas clinical data
  • Updates on the Real World Data pilot program to reduce clinical trial cost and time

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China Adverse Event and Post Market Surveillance 2019June 17, 2019

This webinar covers China post market surveillance (PMS). NMPA (CFDA) has started to put more emphasis on post market supervision than ever before. Three key areas will be discussed: adverse events (AE), recalls and overseas inspection. Two key regulations were issued in the past year on AEs and overseas inspection.

Watch a 30-second introduction:

Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation issued on August 31st was implemented January 1st, 2019. For the 1st time, NMPA (CFDA) imposed severe penalties for violations. On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. Provincial NMPA (CFDA) offices will take major responsibility for surveillance whereas overseas inspection responsibility resides at the national NMPA (CFDA) office.

Topics will cover:

  • What are the current status of AE and recalls?
  • What are the requirements and penalties for AE reporting?
  • What should foreign companies do to comply with China new PMS requirements?
  • What is the best practice for overseas inspection from preparation to on-site inspection to post inspection follow up?
  • What are the requirements for NMPA (CFDA) recalls?

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