China’s Center for Medical Device Evaluation (CMDE) has issued a new draft guidance for obtaining approval of 3D-printed medical devices, as the nation’s regulatory authorities focus new attention on the fast-developing field of 3D printing technology.
The guidance, proposed by the agency in March, would require manufacturers seeking to produce 3D medical devices to test and validate all printing equipment, raw materials, processes, software, and final products before they are submitted to the China Food and Drug Administration (CFDA) for approval. Manufacturers must verify testing of anti-pull strength and fatigue for the devices, along with testing of the usability and functionality of new devices and any components related to them. They would also be required to include the chemical composition of each device, research data on product performance, the product’s intended uses, and potential environmental impacts.
The guidance would apply to a wide range of devices, including bone, joint, and dental implants, as well as biomaterials and pharmaceuticals produced using additive manufacturing. It is subject to input from industry stakeholders before it becomes final.