As a rapid prototyping technique in additive manufacturing, 3D printing has the advantage of producing patient-specific devices and enabling customized medical services. Focusing on the standards for additive manufacturing, this paper analyzes the development of its international standard and the framework of general standard system for 3D printing, and introduces the policy, technical committee, provisions for registration and training system. A roadmap for the medical device development in China through combining domestic general standard, application standard and registration testing with the international 3D printing standards is put forward to promote 3D printing in medical field.

3D printing  /  medical device  /  standardization  /  registration