Getting to Yes from Regulators to Payers and Beyond - the Decision-Maker Gauntlet
Market Access, Payment & Health Care Delivery Issues
China is the 2nd largest medtech market with 20% annual growth rate. The session will cover key China market access updates: NMPA (CFDA) Major regulatory and clinical affairs updates, IP reform, Reimbursement and their implications on overseas manufacturers.
China NMPA (CFDA):
Recent Developments in China Medical and IVD Devices: MAH/Legal Agents and the Implications in local manufacturing and product registration. China Post Market Compliance and the mandatory reporting. Innovation, companion diagnostic/biomarker(CDx), combination device classification, Registration Guidelines Revision Plan.
UDI has implications on everyone. What is its status and implementation?
China is reforming its IP law. What is the status with IP protection for both domestic and overseas companies?
China NMPA (CFDA) Clinical Affairs Key Updates:
Clinical updates to support regulatory registration and compliance: as the chairing country for the IMDRF clinical evaluation committee, what are the latest updates in the real world evidence, clinical trial/evaluation, international clinical data acceptance guideline? How do you know which path to take or combine to mitigate the clinical trial requirements?
Has the acceptance of overseas clinical data been successful in avoiding clinical trial or reducing clinical trial sample size? How to provide Chinese ethnic justification?
China Reimbursement Reform:
China reimbursement frame work and concepts: high level key differences between China and US reimbursement systems, China provincial vs national reimbursement vs private payment system.
US based executive practical perspectives on prioritizing China provincial reimbursements efforts, obtaining patient charge codes and reimbursements for new product and existing product codes and reimbursements. What are the lessons learned?