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2024 China NMPA Bluebook is here:

Navigating SaMD Registration Requirements: China & US PerspectivesMay 28, 2024

Join our webinar to gain insights into the evolving regulatory landscape for Software as a Medical Device (SaMD) products in both the China NMPA and the U.S. FDA. As digital health technologies continue to advance, SaMD has emerged as a significant sector in the medical device industry. In the U.S., the FDA has been actively developing a regulatory framework to ensure the safety and effectiveness of SaMD, while in China, the NMPA is also making strides in establishing regulations that align with its unique healthcare ecosystem.
Our expert speaker will delve into the key requirements, processes, and approval criteria for SaMD products in these two largest Medtech markets in the world, providing you with a comprehensive understanding of the nuances and complexities involved in navigating these regulatory environments.
After this 60-minute webinar, you will have a practical understanding of the following areas about SaMD registration in China NMPA and US FDA:
• General regulatory landscape of SaMD
• SaMD Key Regulations and Standards
• Specific SaMD classification and naming rules
• General of Requirements of SaMD Registration
• Clinical Evaluation Requirements


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The New Landscape of China Clinical Evaluation (Part III): How to Prepare for Clinical Trial AuditApril 30, 2024

Auditing is one of the important procedures in the clinical trial quality management system. It is a systematic and independent audit of clinical trial-related activities and documents to evaluate and determine whether the implementation of clinical trial-related activities, the recording, analysis and reporting of trial data comply with protocol, standard operating procedures and relevant laws and regulations.
Join our exclusive webinar as we delve into the intricacies of China NMPA clinical trial onsite audits. Led by seasoned industry experts, this webinar will provide invaluable insights into the entire audit process, from preparation to execution and post-audit follow-up.
* Overview of China NMPA regulations: understand the regulatory framework governing clinical trials in China and the role of NMPA in ensuring compliance
* Preparing for onsite audits: learn best practices for preparing your organization, facilities, and personnel for NMPA audits
* Navigating the audit process: gain a step-by-step understanding of what to expect during an onsite audit, including key areas of focus, common pitfalls, and strategies for success
* Case study and key takeaways


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The New Landscape of China Clinical Evaluation: Diversified Pathways to Expedite your Market Approval (Part II)March 28, 2024

Struggling to navigate the intricacies of clinical trial implementation in China? Part II of our webinar series delves deeper into the practical aspects of conducting clinical trials in China for successful NMPA submissions.
Join us as we dissect the critical elements of China's clinical trial framework, focusing on the China GCP, administrative requirements, implementation strategies, regulations about Human Genetic Resources.
* Explore the clinical evaluation requirement for product registration in China
* Learn about the China GCP and clinical trial requirements
* Learn about the clinical trial implementation
* Explore the regulations about Human Genetic Resources related to implementation of clinical trials
* Understand the role of RWE in clinical evidence to support product registration.


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The New Landscape of China Clinical Evaluation: Diversified Pathways to Expedite your Market Approval (Part I)February 29, 2024

Are you struggling to understand the clinical evaluation requirements and how to leverage clinical data for China NMPA submission? This session will take a deep dive into the evolving regulations on clinical evaluation in China. Topics will cover clinical evaluation pathways, decision tree, principles and processes, key factors in clinical evaluation report (CER). The session will also touch upon the real-world data/study (RWS/D) in China pilot zone and discuss when and how to utilize RWD to support submission pre or post marketing could minimize the cost and time to market entry.

  • Understand the framework of clinical evaluation in China: regulations, guidelines and requirements
  • Explore the different pathways of clinical evaluation in China and how to determine the pathway based on the decision tree
  • Discover how the overseas clinical data can be leveraged in more versatile ways to support regulatory approval.
  • Learn how to demonstrate product equivalence and find out the key factors of writing clinical evaluation report (CER)
  • 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.

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Medical Device Made-in-China Policy: A Comprehensive Review and ImplementationJanuary 18, 2024

China is re-opening to the world after COVID isolation in 2023. Volume based purchasing and Made-in-China (MIC) policy are becoming more important in the public hospital purchases. This webinar will discuss the ways overseas manufacturers and innovators can shorten time-to-market, reduce cost and increase sales for the increasing significant role of “Made-in-China” policy. The session will also review the key regulatory policies, guideline requirements regarding the policy to understand the requirements, criteria, and benefits. In addition, the different models of made-in-China policy will be discussed. Overseas manufacturers can create a strategy and implementation plan to leverage the “Made-in-China” policy. The process of utilizing in-China contract manufacturing option will be discussed as well.

  • China MedTech Market High level review
  • The background and relevant regulation of Made-in-China (MIC) policy
  • Benefits of operating under MAH
  • Different models and approaches to achieve MIC policy
  • OEM Responsibilities for Registering New Devices under MAH
  • How to choose a CM operating under MAH
  • Key process and steps to establish MIC with contract manufacturer in China
  • The relationship between made-in-China policy with volume-based purchasing
  • Case Study

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Understanding IVD Reagents Registration Requirements: China & US PerspectivesNovember 7, 2023

Join our webinar to stay up to date on the changing regulatory landscape in both China NMPA and US FDA for In Vitro Diagnostics (IVD) reagents. Our expert speaker will explore the key requirements, processes, and approval criteria for reagent products in these 2 largest Medtech markets in the world.

After this 75-minute webinar you will have a practical understanding of the following areas about IVD reagents registration:

China NMPA

  • General regulatory landscape of IVD reagents
  • Specific IVD classification rules and registration unit division
  • Registration dossier requirements and best practices
  • Significant NMPA requirements that you need to comply for your type testing success
  • Using Overseas Clinical Trial Data for China submission
  • Regulation on human genetic resources for clinical studies

US FDA

  • FDA risk classification for IVDs
  • Requirements for registration and listings of IVD products
  • 510K exempt devices
  • Concept of general controls
  • Special controls and pre-market approval

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Key Regulatory Changes from 2022 and Look Ahead to 2023March 9, 2023

Join our webinar to stay up-to-date on the changing regulatory landscape for medical devices in China. With ongoing implementation of Order 739 and the country's re-opening to the world, it's more important than ever to stay informed.

Our expert speaker will review key policies, guidelines and standards from the past several months, as well as provide insights on what to expect for the remainder of 2023. They will also share strategies for manufacturers and innovators to shorten time-to-market, mitigate impacts of PTR tests and standards changes, and avoid penalties from post-market compliance inspections.

• How to leverage Order 739 to shorten the time-consuming product technical requirements (PTR) writing process and local type testing.
• Greater Bay Area and Hainan special policies for use of non-approved devices within China.
• “Made in China” requirements and policies around market authorization holders (MAH).
• New perspectives on clinical evaluation pathways, including clinical evaluation decision tree, overseas clinical data acceptance, clinical trials, and piloted real-world data.


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Part 2 - Labeling and IFU - Enhanced Requirements of Post Market Surveillance Per Order 739October 6, 2022

In our previous Part I webinar, we gave the big picture of China PMS/GMP requirements and talked about the major updates per Order 739. Our Part II webinar will focus on Labeling and IFU, the two critical documents that must be consistent with NMPA approved certificates to comply with China post market requirements. Violations could result in recall or products being held up at customs.
More and more overseas manufacturers are having their products made in China to compete more favorably. Whether the devices sold in China are from overseas imports or domestically made, they must meet China GMP and post market requirements. After the implementation of the Order 739: Regulations on Supervision and Administration of Medical Devices in June 2021, China has been increasing its surveillance on post market monitoring with more follow-on guidelines and unannounced inspections both inside and outside China. Knowing more about the newly published guidelines, and learning from the previous cases, get more insights to comply with China PMS/GMP regulations!

Our Part II session will address the topics of:

  • China NMPA definition of labels and IFU
  • Relevant regulations of labels and IFU
  • Best Practices for labels and IFU compliance and remediation

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Part 1 - Overview PMS Key Updates - Enhanced Requirements of Post Market Surveillance Per Order 739August 25, 2022

More and more overseas manufacturers are having their products made in China to compete more favorably. Whether the devices sold in China are from overseas imports or domestically made, they must be in compliance with China GMP. After the implementation of the Order 739: Regulations on Supervision and Administration of Medical Devices in June 2021, China has been increasing its surveillance on post market monitoring with more follow-on guidelines and random inspections both inside China and outside of China. Knowing more about the newly published guidelines, and learning from the previous cases, get more insights to comply with China PMS/GMP Regulations!

This session will address the key topics of:

  • More rigorous PMS/GMP requirements per Order 739
  • Newly updated PMS/GMP Guidelines
  • Typical Observations in Post Market Overseas Inspections
  • Best Practices for Post Market QMS compliance and remediation – Product Verification with China PTR

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2021 NMPA CFDA Key Updates and Look Ahead on 2022April 16, 2022

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)


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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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