2023 NMPA (CFDA) Key Updates and Look Ahead on 2024 (On-Demand)
China is re-opening to the world after COVID isolation in 2023. As the only double-digit growth country in MedTech, 2nd largest market in the world, China market entry has its challenges to enter and sustain the growth. We will review key policies, guidelines, standards, and announcements in the past and look ahead 2024. How can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, impacts of PTR tests and standards change, different clinical pathway and RWD program, increased post market compliance inspections and the penalties? In addition, there is also the emerging Made-In-China policy and innovation approval to enjoy premium pricing.
Registration Fees & Deadlines
Member $0| Non-Member $50
Learning Objectives
- New law, regulation, policy, standards & guidelines in 2023.
- Leverage the latest regulations to shorten the time-consuming local type testing.
- Latest clinical evaluation requirements: decision tree, overseas clinical data, clinical trial, CER, piloted real-world data.
- "Made-in-China" policy to shorten time-to-market: definition, criteria, requirements and different models.
- Green pathway to enjoy special pricing and exempt from China Volume Based Purchasing (VBP).
- Great Bay Area & Hainan pilot policy for NMPA un-approved devices use in China.
- Post market Surveillance and Quality Management System (UDI, NHSA code, AE, Recall and Inspection).
Who Should Attend?
Recently, there have been significant changes in the requirements around human factors for medical devices. This workshop will provide practical guidance and information for:
- Clinical affairs professionals
- Managers in the life sciences industry
- Regulatory affairs professionals
- Quality affairs professionals
- Medical affairs professionals
- R&D managers
- Compliance managers
- Operations managers
- Marketing and business executives
- Chief financial and commercial managers
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Speakers
Grace Fu
Principal, China Med Device
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
