Resources

Recorded Webinars

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

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
2021 New Updates: China NMPA Medical Device Clinical Pathways

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
Learn to Comply With China

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

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
China IVD Registration Pitfalls and COVID-19 Test Kit Updates

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
China Mandatory Period Risk Evaluation Report and the latest PMS Requirements in NMPA and FDA

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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Update on China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19April 8, 2020
Update on China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19

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 (CFDA) Key Updates & Trends: Look Ahead to 2020January 27, 2020
2019 NMPA (CFDA) Key Updates & Trends: Look Ahead to 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’s NMPA Latest Regulatory Updates with PMS QMS FocusJanuary 23, 2020
China’s NMPA Latest Regulatory Updates with PMS QMS Focus

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
Developments in Clinical Pathways for NMPA (CFDA) Submission

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 SurveillanceJune 17, 2019
China Adverse Event and Post Market Surveillance

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?

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How to Navigate Type Testing in ChinaApril 4, 2019
How to Navigate Type Testing in China

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!


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Era of Transformation 2018 NMPA (CFDA) Major Regulation UpdatesDecember 27, 2018
Era of Transformation 2018 NMPA (CFDA) Major Regulation Updates

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

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NMPA (CFDA) Overseas Inspection VideoAugust 16, 2018
NMPA (CFDA) Overseas Inspection Video

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?


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Key Ingredients for Effective NMPA (CFDA) CER & Clinical TrialJune 13, 2018
Key Ingredients for Effective NMPA (CFDA) CER & Clinical Trial

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?

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Success Factors In China MedTech MarketMay 3, 2018
Success Factors In China MedTech Market

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

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How To Get IVD Approval Through NMPA (CFDA)January 17, 2018
How To Get IVD Approval Through NMPA (CFDA)

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

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NMPA (CFDA) Key Updates GMP/QMS OverviewJanuary 31, 2017
NMPA (CFDA) Key Updates GMP/QMS Overview

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.

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