2022 NMPA (CFDA) Key Updates and Look Ahead (On-Demand)
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.
Instructors:
Grace Fu Palma brings more than 20 years of industry experience to the discussion. Serving as the CEO of China Med Device (www.ChinaMedDevice.com), with offices in Beijing and Boston, Grace provides immediate solutions that Western medical-device companies can implement to master China's NMPA process. China Med Device has processed more than 1,000 CFDA certificates and has assisted more than 250 Chinese and Western companies. A seasoned bilingual and bicultural MedTech executive, Grace has held a variety of marketing, operational, and strategic-development management positions at both large multinationals (Hewlett Packard Medical) and startup companies (Teratech). She specializes in China NMPA (CFDA) regulatory (RA/QA/CRO/CER) and commercialization services. In addition, she founded the Chinese American Heart
