In September 2015, the first 3D printed human body implant – the artificial hip joint was approved in China by the China Food and Drug Administration (CFDA). The CFDA has to date approved four 3D printed products: the 3D printed hip joint, the 3D printed artificial vertebral body, 3D printed spinal intervertebral fusion device, and the 3D printed dura mater (spine) graft. Although China has attached great importance to the development of 3D printing technology, the CFDA has not established comprehensive guidelines to regulate the development of and marketing authorization for 3D printed products in China.
Compared to traditional technologies, Chinese administrative departments possess less regulatory experience to the use, manufacturing, and marketing of 3D printed products. Moreover, no national and industrial technical standards currently exist in China to direct the design, testing, and manufacturing of 3D printed products, which creates hurdles in the quality control and technical review processes of 3D printed products by the regulatory agency. What’s more, the current medical device guidelines, such as the medical device, GMP, and GSP, are mainly used to regulate devices using conventional technologies.
There exist some difficulties in the technical evaluation of 3D printed medical devices for both the industry and the regulatory authority. The first problem concerns the classification of 3D printed products. It is difficult to classify a 3D printed medical device according to the traditional classification experience, due to a 3D printed device’s unique structure and application. The CFDA has currently incorporated eight categories of 3D printed products, including orthopedic implants, into the list of Class III medical devices that require clinical trials.
Secondly, the materials and equipment used are two major factors that affect the safety and efficacy of 3D printed products. With the development of 3D printing technology, printing materials have been evolving from non-biocompatibility materials to live cells, proteins, and extracellular matrix, which require different quality control standards.
Thirdly, from the technical review perspective, the safety and efficacy of 3D printing technologies and materials are the most important aspects for evaluation. However, there are no relevant regulations to provide the methodologies, procedures, and key points for the technical review of 3D printed products.
Because of limited knowledge and experience about the life cycle, testing, manufacturing, and technical review of 3D printing technology, there is still a long way to go for both the industry and the regulatory agency to establish a comprehensive regulatory system for 3D printing products.
Published in 2015, the strategic plan Made in China 2025 classified 3D printing as one of the nation’s emphasized development industry. On March 9, 2016, The Ministry of Science and Technology of PRC included customized implants, interventional devices, and biological 3D printing into the target of government assistance, giving financial subsidies to accelerate the rapid incumbent and growth of the technology.
The most recent policy for 3D printing technology involves the “Medical Device Innovation Plan” issued by the Ministry of Science and Technology on May 26, 2017, which mentioned 3D printing as the technology that drives the customization, intellectualization, and robotization of medical devices.
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