More than two and a half years after the China Food and Drug Administration (CFDA) formally approved its first three-dimensional (3D) printed medical device for mass production, a hip implant co-developed by Peking University’s Third Hospital and AK Medical, the agency has issued a draft guidance on the regulatory requirements for approval of 3D printed devices. The new guidance, titled “Guidelines for the Technical Review of Custom Additive Manufacturing Medical Device Registration,” proposes that “[t]he process of production and verification of custom-built additive-produced medical devices should, in particular, control the testing of printing equipment, processes, post-processing, raw materials and final products, as well as cleaning, packaging and sterilization.”

Although the CFDA is open to consultation on the guidance until March 30, the existing draft would require 3D device applicants to provide at least (1) a product name according to its scope and design for classification and standardization purposes; (2) a description of the product including the chemical composition of each component; (3) clinically relevant model specifications; (4) the scope of the application and contraindications; (5) the product’s research and development background with a comparison to similar products; and (6) research data on product performance with supplementary material characterization.

This development is in line with increased attention to 3D printing technology by regulatory authorities worldwide. In December 2017, the U.S. Food and Drug Administration (FDA) published its guidance titled “Technical Considerations for Additive Manufactured Medical Devices,” which provided the agency’s initial thoughts on 3D printing, including important considerations for design, manufacturing, device testing, and premarket approval. This initial non-binding document was published as “a type of guidance that serves as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance,” and identified the significant issues that the FDA was likely to emphasize in future regulations. Similarly, Australia’s Therapeutic Goods Administration (TGA) opened consultation on the topic in November 2017.

Written by: Bryan Johnson