This session aims to provide a comprehensive exploration of navigating the intricate regulatory landscape in the East and Southeast Asia region beyond China, offering strategic insights and practical approaches for achieving successful market access. With diverse regulatory frameworks, cultural nuances, and varying compliance requirements across countries, businesses face unique challenges. This session will equip attendees with the knowledge and strategies necessary to navigate regulatory hurdles and optimize market entry.

Introduction to Regulatory Environment:

• Overview of the regulatory landscape in key countries (e.g., Japan, South Korea, Philippines, Thailand, Malaysia, India, etc.)
• Recent regulatory changes and trends impacting product registration
• Challenges and pain points in navigating the complex regulatory environment

Developing Tailored Regulatory Strategies:

• Crafting a customized regulatory approach for each market
• Finding opportunities to harmonize requirements and streamline processes

Best Practices for Regulatory Submission:

• Practical tips for preparing and submitting regulatory documents
• Streamlining approval processes for faster market entry

The role of usability and human factors in medical devices has become globally important across most of the key countries. In this session, we will focus on US and China to review the human factors extending beyond design and into registration and post-market phases. Join us for a comprehensive webinar that explores this crucial topic, focusing on the unique landscapes of China and the United States.

• The Global Rising Importance : An introduction to why usability and human factors have become integral in medical device lifecycle.
• Regulatory Insights: A comparative study of the regulatory guidelines in China and the U.S., highlighting the common and different requirements
• Key Steps of Human Factor Studies & Design Strategies: how to design and implement the human factor studies
• Real-world Examples & Best Practices

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

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