April 9th, 2018
CFDA has released the draft of 3D-printed medical device guidance during the last week of February. The draft guidance provides the general requirements of registration rules on 3D printed medical device.
In the guidance, it was proposed that physicians and other healthcare professionals should be involved for the design input and output of 3D-printed medical devices. In effect, the customized device can solve the clinical problem which the general medical device cannot approach. Medical devices applicable to this draft guidance include implantable medical devices, such as orthopedic, joint, and oral medical devices. Some medical devices containing drug, cellular, or tissue materials are not applicable to this guidance, but the applicant may use it as reference.
The highlighted contents in the guidance are as follows:
1. The performance report: CFDA seeks information regarding the material of construction and mechanical performance, product structure, biocompatibility, disinfection and sterilization, shelf-life, packaging test and results of animal testing.
2. The manufacturing process and verification report: the applicant shall provide the verification report of manufacturing process, post-processing, raw material, and final product. The report shall include different aspects, such as the software verification, instrument verification (3Q validation and stability test), and the raw material verification.
3. The product development report: the manufacturer shall provide the documents to verify that they coordinated with the clinical physician closely during the product development stage.