Practical Implications and Changes Post Order 739 for Medical Devices and IVD in China

China has become one of the most challenging countries to obtain new product registration approval. NMPA (China FDA) has been going through transformational changes in the past few years. State Order 739, effective June 1st, 2021, set the legal framework at the highest level, paved the way for more international harmonization and streamlined and expanded the regulations for the complete product life cycle in medical devices and IVDs. The session will cover the key changes and implications associated with the series of subsequent regulations, guidelines, and notices post State Order 739. These subsequent updates include but are not limited to:
(1) Expanded choices for the time-consuming PTR writing and local type testing
(2) More clarity and directions for deciding when to do a clinical trial, when to use predicate devices to write similar products comparison CER
(3) More flexibility in utilizing the various forms of clinical data and studies to determine the clinical evidence pathway to minimize clinical trial.
(4) More risk management principal and increased accountability at both enterprise and personal levels.

Agenda:
(1) Introduction and framework of Order 739
(2) Implications and impacts on medical devices in premarket submission, clinical trial, and evaluation post Order 739
(3) Implications and impacts on IVD in premarket submission, clinical trial, and evaluation post Order 739
(4) Post market requirement updates post Order 739