Supervision points of raw materials and manufacturing process of personalized medical devices

In recent years, additive manufacturing technology is developing rapidly, and its characteristics such as accurate process, low cost, high degree of automation, production can be customized gradually appear. Different from the large-scale production characteristics of reduced material manufacturing technology, customized production perfectly matches the demand of precision medicine in the medical field. It has become a consensus in the medical field that personalized medical devices are used to replace the old standardized products.

In the face of this situation, domestic and foreign regulatory authorities and academic circles have carried out exploration and thinking. FDA of the United States has issued a guideline for personalized additive manufacturing of medical devices, and Europe has also carried out relevant thinking and discussion. A few days ago, the State Drug Administration and the State Health Commission jointly issued the "Regulations on the supervision and administration of customized medical devices (Trial)".

According to the existing key points of evaluation and approval of personalized denture, customized orthosis, and the first additive manufacturing personalized knee orthosis in China, this paper analyzes and puts forward the supervision idea of ensuring the safety and effectiveness of personalized medical devices from the design and manufacturing process control based on the supervision idea of patient matching design proposed by FDA and EU for additive manufacturing medical devices The control requirements of materials, process verification and validation of design and manufacture, sterilization process requirements and other regulatory points were confirmed for reference of regulatory agencies and enterprises.