As we all know, the State Food and Drug Administration formally approved the manufacture and use of 3D-printed hip implants in 2015, especially implants made using metal 3D printing technology. This month, the State Food and Drug Administration’s medical device technology review The Center (CMDE) released a new draft on the regulatory requirements for the complex 3D printed medical device sector.
It is understood that the draft is entitled 'Guidance on Custom 3D Printed Medical Device Registration Technical Examination' to answer industry questions and how the CFDA will address the registration of important 3D printed medical devices in the Chinese market. Review.
The new guide points out: 'The purpose of this guide is to encourage the development of innovative medical devices, to provide technical guidance for applicants to apply for registration of medical devices for 3D printing, and to provide technical references for the review of registered files.
In addition to addressing industry issues, the guideline also proposes specific requirements for the testing and validation of any 3D printed medical device product submitted for CFDA approval.
The new guide covers 3D printed dental and orthopedic medical device implants as well as 3D printed biomaterials and drugs.
It is worth mentioning that this guide does not cover all the requirements for medical devices that specifically design a pharmaceutical composition containing cells, tissues and other biologically active substances in biological 3D printing, but it can refer to the specific requirements of applicable requirements.
The CFDA has proposed various important regulatory recommendations in the new guide, such as requiring verification testing of all 3D printing equipment, materials, processes, software, and final products. It also states that product validation should include tensile strength and fatigue testing. Usability testing, functional testing, and evaluating any components related to these.
In addition, the new CFDA guidelines recommend that clinicians and healthcare professionals participate in design input and output decisions for 3D printed medical devices, and must define 3D printing environmental parameters including energy density, gas composition, humidity, pressure, 3D print speed, Temperature and other related factors.
The new guidelines also point out that additive manufacturers should require their own cleansing of complex 3D-printed medical devices rather than outsourcing these devices to other companies. It must also demonstrate the effectiveness of the cleaning methods used. For products sterilized by radiation, Need radiation dose and related verification report.
Part of the new guide is about using animal models to test 3D printed medical implants. Finally, the new draft of the State Food and Drug Administration pointed out that the use of 3D printed medical implants requires a manufacturer, a health care provider, and a patient Contracts.
At present, the State Food and Drug Administration is seeking opinions from the industry on its new guidelines.
CMDE stated: 'In order to make the new guide more scientific, reasonable and practical, we will publicly solicit opinions on our official website from now on. We sincerely hope that experts, scholars, managers and practitioners in related fields can put forward constructive opinions. Or suggestions. The enrichment and improvement of the new guide will improve the quality and efficiency of registration declarations and technical reviews.'
When the comments on the new guide draft are closed and the compilation is completed, the State Food and Drug Administration will publish the final version of the new guidelines for 3D printed medical devices.
