The participants had an enthusiastic discussion on the guideline, especially on the additive manufacturing process and the customized design that entails doctor-engineer interaction. They put forward feasible suggestions on the management and access requirement of 3D reconstruction softwares, raw material powder and 3D printers. Some enterprises held that the review guideline for registration of Class 2 customized medical devices shall be formulated to further improve the guideline system for medical devices and guide enterprises for registration. CMDE carefully took the comments and suggestions from representatives. According to the discussion in the meeting, the comments and suggestions solicited at the forum will be analyzed and studied for further improvement of the registration guideline.
Over 70 people attended the forum, including the Secretariat Head of 3D Print Specialized Committee of CAMDI, enterprise representatives for R&D of 3D print medical device, clinical experts in medical institutions and reviewers from relevant departments of CMDE.