China Clinical Requirements Update
On 13th December, the CMDE published the Public Consultation (Deadline: 13 Jan 2020) on “Technical Guidance on Using Real-World Data for Clinical Evaluation of Medical Devices (Draft for Comments)”. This newly issued draft is intended to explore the feasibility and method of using real-world data for regulatory decision-making as well as provide new solutions for accelerating the market launch of medical devices.
ARQon deduces the draft for comments on using real-world data for clinical evaluation may have some impact on foreign manufacturers.
As foreign manufacturers can potentially collect real-world data from other countries to form real-world evidence, this evidence will be beneficial for registration in China.