Unlocking China's SaMD Market: Regulatory Pathways and Challenges
October 30, 2024
45 Minutes
Join the Webinar at your Convenient Time
For AMR and EUA Region
10.00 AM EDT / 9.00 AM CDT/ 4.00 PM CET
For Rest of The World Region
11.30 AM IST
What is it all about?
With China being the world’s second-largest medical device market, projected to reach $66 billion by 2025, and the SaMD sector growing at an annual rate of over 20%, the regulatory landscape is evolving rapidly. In 2023 alone, China’s National Medical Products Administration (NMPA) approved more than 200 new SaMD products, demonstrating the country's increasing focus on digital health solutions. This webinar provides an in-depth guide on navigating the NMPA’s complex registration process for Software as a Medical Device (SaMD), essential for market entry and sustained compliance in this booming sector.
The webinar will be hosted by Ji Yun Jung- Assistant Manager, Business Development, Freyr South Korea and presented by Allan Zhang- Manager, Medical Devices, Freyr China
In brief, the topics to be discussed during the webinar include:
- China NMPA requirements for SaMD registration
- SaMD product classification and application numbers
- Relevant standards and local type testing requirements for SaMD
- Clinical evaluation pathway for SaMD
- Registration documents requirement for SaMD
- Guideline for software product registration overview
- Guideline for SaMD Cybersecurity overview
- NMPA requirements for SaMD version upgrade
- FAQs
Ji Yun (June) Jung is a Client Partner and Business Development Manager at Freyr solutions. With eight (08)+ years' experience in biotechnology field, June has profound experiences in handling the business aspects of pharmaceutical, medical device, and the consumer (cosmetics, food and food supplements, and chemical products) industries. She currently handles the needs of the Korean market.
With 10 years experience of medical device registration. Allan has rich experience in active and non-active medical device, guiding numerous foreign and local manufacturing companies and helping them to get more than 100 certificates approved by NMPA. He had participated in drafting CMDE guideline and industry standards. He can guide manufacture with fast and compliant registration strategy.
Host
Ji Yun (June) Jung
Assistant Manager- Business Development
Presenter
Allan Zhang
Manager- Medical Devices, Freyr China