The China Food and Drug Administration (CFDA) has released a draft guidance covering the regulation of customized 3D-printed medical devices.
Among various recommendations set forth by the CFDA in the draft, applicants seeking to register their 3D-printed products are required to provide information regarding six technical considerations:
- Standardized product name, including management category for the product and coding classification
- Description of the product, including the chemical composition of every component
- Specifications that are clinically relevant
- Scope of the device's application, as well as any contraindications
- Background of the product's research and development, with comparisons to similar products
- Research data on product performance
Manufacturers will also have to obtain verification for every step of the process, especially the testing of 3D printing equipment as well as postprocessing, cleaning, packaging, and sterilizing 3D-printed devices. The agency hopes the eventual preparation of a final guidance will promote the development of new individually tailored medical devices.
