China NMPA has created several special fast-track registration channels for medical devices. To further expedite green channel pathways, China announced recently that approved innovative products can enjoy special pricing with higher premium enjoy reimbursement and exempt from China Volume based Purchasing (VBP).
China is the second largest MedTech market and the only country with continuous double-digit growth. How can overseas companies benefit from accessing the China market faster with these special pathways? Innovation is one of the pre-market submission pathways with equal opportunity for both overseas and domestic manufacturers. In addition, there are other special pathways.
Registration Fees & Deadlines
20 October, 2023 – 10 March, 2024, Year: Member $150 | Nonmember $175
11 March 2024 – 10 April 2024: Member $175 | Nonmember $200
Learning Objectives
After this program, participants will be able to:
- Describe what are the green pathways, and list criteria and requirements of innovation pathway
- Define the innovation special review dossier process and implement the advantages and considerations of fast-track channel in their real practice
- Accelerate go-to-market strategy by implementing the benefits of innovative products in VBP, pricing and reimbursement
Who Should Attend?
- 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
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Agenda
Innovation Pathway
- Overall Introduction
- Regulations & Eligibility
- Dossier Preparation
- Application Procedure
- Advantages and Takeaways
Speakers
Grace Fu Palma
Principal, ChinaMed Device, LLC
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 support@raps.org. 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 support@raps.org 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.
Questions
Contact the RAPS Support Center: Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org