CFDA Releases Draft Guidance on Technical Review for Registration of Custom-Made Additive Manufactured Medical Devices
On February 26, 2018, VCBeat learned that the China Food and Drug Administration (CFDA) and the Center for Medical Device Evaluation had issued a notice soliciting public comments on the “Technical Review Guidelines for the Registration of Customized Additively Manufactured Medical Devices (Draft for Comment).”
This marks the gradual implementation of policies related to 3D-printed medical devices, representing a significant positive development for the medical 3D printing sector.
The main contents are as follows:
To all relevant entities:
To support and encourage the research and development of customized additive manufacturing medical devices and meet clinical needs, our Center has organized the drafting of the “Technical Review Guidelines for the Registration of Customized Additive Manufacturing Medical Devices (Draft for Comments).”
To enhance the scientific rationality and practical operability of these guidelines, we are hereby soliciting public comments on our center’s website. We sincerely invite experts, scholars, administrators, and practitioners in relevant fields to provide constructive opinions or suggestions, thereby facilitating the enrichment and improvement of the guidelines and promoting the quality and efficiency of registration submissions and technical reviews.
Please send your comments or suggestions to our center via email by March 30, 2018. Contact information:
Contacts: Min Yue, Zhai Bao
Tel: 010-86452806; 010-86452828
Email: minyue@cmde.org.cn
These guidelines are intended to encourage innovative development of medical devices, provide technical guidance to applicants for the registration and filing of customized additive manufacturing (or “3D printing”) medical device products, and serve as a technical reference for food and drug regulatory authorities in the review of registration and filing submissions.
This Guideline sets forth the general requirements for registration application materials for custom-made additive manufactured medical devices. Applicants shall enrich and refine the content of the registration application materials based on the specific characteristics of their products, and determine the applicability of the specific content herein according to such product-specific characteristics.
This guideline serves as guidance for applicants and reviewers; it does not cover administrative matters related to registration approval, nor is it legally binding. Alternative approaches that meet the requirements of applicable regulations may be adopted, provided that detailed research and validation data are submitted. This guideline should be applied in compliance with relevant regulations and standards.。
This Guideline is formulated based on the current regulatory and standard systems as well as the present level of scientific understanding. As regulations and standards continue to be refined and science and technology advance, the relevant content of this Guideline will be adjusted in a timely manner.
This guideline applies to the following scenarios:
Custom-designed medical devices, proposed by clinicians and manufactured via additive manufacturing processes, are tailored to specific lesion conditions and/or adapted to unique anatomical structures, aiming to address clinical needs that are difficult to meet with existing standardized medical devices or to better satisfy specialized clinical requirements.
This guideline covers passive implantable medical devices for bones, joints, and teeth. It does not cover all requirements for specially designed medical devices, such as those manufactured using bio-3D printing that contain bioactive substances like drug components, cells, or tissues; however, the applicable specific requirements herein may be referenced. For custom-made additive-manufactured passive non-implantable medical devices, the applicable specific requirements herein may also be referenced.。
This content is sourced from the official website of the Center for Medical Device Evaluation, National Medical Products Administration.
Detailed download link for the draft for comments:http://www.cmde.org.cn/CL0004/6954.html