Key points for supervision of raw materials, manufacturing processes, etc. of personalized medical devices

In recent years, additive manufacturing technology has developed rapidly, and its characteristics of precise process, low cost, high degree of automation, and customizable production have gradually emerged. Different from the large-scale standardized production characteristics of subtractive manufacturing technology, customized production perfectly matches the needs of precision medicine in the medical field. The voices of the domestic and foreign industries for the use of personalized medical devices to replace the old standardized products are getting louder and louder, and it has gradually become a consensus in the medical community.

Faced with this situation, domestic and foreign regulatory authorities and academia have explored and thought about it. The US FDA has issued a guide to personalized additive manufacturing medical devices, and Europe has also conducted relevant thinking and discussion. Recently, the National Medical Products Administration and the National Health Commission jointly issued the "Regulations on the Supervision and Management of Customized Medical Devices (Trial)".

Based on the key review and approval points of existing personalized dentures, custom orthotics, and the first additively manufactured personalized knee orthosis in China, this article draws on the regulatory ideas of patient-matched design proposed by the US FDA and the EU for additively manufactured medical devices, analyzes and proposes regulatory ideas to ensure the safety and effectiveness of personalized medical devices from the perspective of design and production process control, clarifies the key regulatory points such as material control requirements, process verification and confirmation of design and production, and sterilization process requirements, for reference by regulatory agencies and companies.