China’s State Order 739 has brought continuous change in regulatory, clinical, and commercial affairs this year. But as the only country with double-digit growth in MedTech, China cannot be ignored just because its market-entry submission process is challenging.

In this strategic program, we will review key policies, guidelines, and standards, and look ahead to 2023. Attendees will identify techniques manufacturers and inventors can implement to shorten their time to market. They’ll also discuss PTR tests, standards’ changes, post-market compliance inspections, and penalties. And we haven’t forgotten the emerging “made-in -China” policies.

REGISTRATION FEES

$0 Member | $25 Nonmember

Learning Objectives

After this program, participants will be able to:

• Full understanding of State Order 739
• Leveraging the order to shorten the time-consuming product technical requirements (PTR) process and local type testing
• Green pathways: higher premiums enjoy reimbursement and are exempt from China Volume-based Purchasing (VBP)
• Great Bay Area & Hainan Special Policy for NMPA un-approved devices use in China
• Mastering “Made in China” requirements and MAH
• New Perspective on Clinical Evaluation Pathways: clinical evaluation decision tree, overseas clinical data acceptance, clinical trial or not, piloted real-world data
• PMS/QMS (NHSA code, AE, Recall & Overseas Inspection)

Audience Learning Level:

Basic: Content is introductory and doesn’t require prior knowledge or experience. Basic educational activities will build a foundation of knowledge and/or competence that can be expanded upon in practice or through higher-level activities.