CAMDI Attending Enterprise Forum Held by CMDE on Technical Review Guideline for Registration of Customized Additive Manufacturing of Medical Devices (Exposure Draft)

  • 2018-03-20

In order to further implement the directives of CFDA on innovation transformation so that the guideline can effectively guide and regulate the registration of medical devices, CMDE of CFDA organized an enterprise forum to solicit comments and suggestions from experts, 3D Device Special Committee of China Association for Medical Devices Industry and enterprise representatives on Guidelines for the Technical Review of Custom Additive Manufacturing Medical Device Registration (Exposure Draft). Lu Bingheng and Dai Kerong, both academicians of China Academy of Engineering, Deputy Director Lu Zhong and relevant experts from National Institutes for Food and Drug Control and Standard Management Center for Medical Devices took part in the forum.

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.