Resources

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

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.

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.

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

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

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.

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

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

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

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

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:

•  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

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

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?

Click to watch this webinar in full length: Subscribe to Watch

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.

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?

China FDA (NMPA) requires local type testing for the market approval of Class II and Class III medical device/IVD products. China local type testing is a mandatory step for registration and must be completed before the initiation of local clinical studies if needed.

Before starting a local type testing in China, you must be ready to answer questions such as:

• What tests need to be done in China?
• Which testing center should I use?
• What Chinese technical standards apply to my products?
• When is the best time to plan for the tests?
• How to write a Product Technical Requirement (PTR)?
• Do certain tests in China need to be repeated?
• Do we need type testing for renewal submissions?

Get answers to these questions and more during this informative webinar!

In Spring 2018, China’s State Council unveiled a plan to reshuffle government ministries. Along with the reshuffling plan, the China Food and Drug Administration has now changed its name to the National Medical Product Administration (NMPA). The name change is just the tip of iceberg. The NMPA changes will offer both opportunities and challenges to many foreign companies targeting the Chinese market.

ChinaMed is offering the online webinar to update you in the following areas:

• Difference between USFDA and NMPA
• Major NMPA Updates in 2018 (Hainan policy, new classification rules, legal agent, registration holder system, overseas clinical data etc.)
• NMPA Registration Updates in the new era
• NMPA Clinical Updates in the new era
• Post-Market Compliance Updates in the new era

Following the 13th Five Year Plan from 2016 to 2020, China FDA (CFDA) is planning to conduct oversea inspection covering all imported high risk imported medical devices. Whether you are selling or planning to sell your medical devices in China, you could receive CFDA oversea inspection notice at some point. So far in 2018, CFDA has published its inspection reports for eight foreign medical devices covering U.S. Europe, Japan, and Australia manufacturers. There are more inspection reports and notice coming out. You could be on the NEXT inspection list! The oversea inspection webinar will include the following contents: 1. Interpretation of the CFDA Medical Device Oversea Inspection Guideline. 2. What are the common observations during the inspection? 2. What are the likely penalties and warnings issued by CFDA? 3. How to prepare for the CFDA oversea inspection?

CFDA clinical requirements for medical device/IVD have been evolving dynamically in the past few years. It is important for foreign manufacturers to understand the China specific clinical requirements, available clinical routes with CFDA registration, and major clinical related regulatory changes.

This webinar will cover the following aspects:

• What are the criteria for different clinical routes in China?
• How much does it cost you to run clinical trials in China?
• When should you decide which clinical route to take in China?
• What are the key ingredients for effective clinical trial in China?

China has become the 2nd largest med-tech market in the world. “Innovation in China” policies under President Xi benefits many domestic and foreign manufacturers in China. Chinese government has determined to spend $125 million over the next three years, promising all citizens the access to basic health care by 2020. The market’s prosperous development will enjoy many American med-tech companies. But there are challenges along the road to success: dynamic regulatory changes and CFDA’s increasingly mature and rigorous registration review.

This webinar will interpret the challenges and solutions in the following areas:

• Why do you choose China: the unique characteristics of China medical device market
• What is new and what you will expect: the changing landscape of med-tech market under key healthcare initiatives
• How to navigate your CFDA approval: registration process, China local testing, innovation pathway, clinical requirements
• How to sell your products: key factors for successful medical device commercialization in China

IVD related CFDA regulations have gone through significant changes and there are more to come in 2018. The classification rules, regulation category and clinical requirements of CFDA are very different FDA. During this webinar Grace will discuss the key factors that will impact your IVD registration success as well as the IVD development trend in China.

After this 90-minute webinar you will have a practical understanding of the following areas:

• Latest key updates of IVD regulations, guidelines, and standards in 2017
• Specific IVD classification rules and registration unit division
• Significant requirements that you need to compliant for your type testing success
• Newest China GCP requirements for your IVD clinical trial and CER
• Different registration pathway and according timeline for IVD registration
• Complete Registration dossier requirements and best practices

During this session Grace will discuss recent developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. These developments can affect all medical device companies, whether your manufacturing facilities are in China or abroad.

After this 90-minute session you will have a practical understanding of the following compliance issues:

• Implementation of the new GMPs, including the procedural rules for inspections, preparation, communicating with investigators, resolving issues, and potential penalties.
• Transfer of manufacturing sites and amendment of manufacturing and device licenses.
• Policies and rules on contract manufacturing for medical devices.
• Handling self-inspections and evaluations of past compliance, including recent examples.