3D-Printed Medical Products: Research, Quality, and Clinical Validation

On May 30, 2025, in Hanoi, the Ministry of Health organized a workshop titled “3D Printing in Healthcare: Research and Development, Quality Assurance, Clinical Evaluation, and Applications.” The event was attended by leaders of the Ministry of Health, representatives from relevant departments and agencies, the National Ethics Committee in Biomedical Research, as well as hospitals, research institutes, enterprises, and experts in 3D printing technology in Vietnam.

At the workshop, the Ministry of Health emphasized that 3D printing technology is rapidly generating innovative applications in clinical practice, contributing to the development of new treatment approaches and techniques. However, it also presents significant challenges related to safety, quality, research ethics, and advertising oversight. Medical 3D-printed products—particularly patient-specific, customized devices—must be supported by scientific evidence of safety and effectiveness and be controlled under national, institutional, and international quality standards.

According to the direction presented at the workshop, research involving 3D-printed medical products in Vietnam must comply with Good Clinical Practice (GCP) standards for new techniques, novel interventions, or medical device clinical investigations, and fully adhere to the regulations outlined in Decree No. 96/2023/ND-CP and Circular No. 32/2023/TT-BYT.

Appendix XXI of Circular 32/2023/TT-BYT clearly stipulates that:

• Clinical investigations of medical devices must be conducted based on protocols and procedures approved by Ethics Committees/Scientific Committees and authorized regulatory bodies.

• Technical documentation, quality management systems, personnel records, and research data must be established, maintained, and archived in accordance with GCP standards.

• Investigators involved in medical device clinical trials are required to have:

• • A valid GCP training certificate issued by the Ministry of Health or an authorized training institution;

• • Certification in safety reporting in clinical trials in accordance with GCP;
    These certifications must be renewed every three years.

In addition, the national standard TCVN 7740 (ISO 14155) on clinical investigation of medical devices in human subjects was highlighted as a key international framework for the design, conduct, and reporting of clinical studies involving medical devices, including 3D-printed products.

These requirements underscore that GCP is no longer limited to pharmaceuticals—it is becoming a mandatory standard for medical device clinical investigations in general, and for personalized 3D-printed products in particular. This ensures that technological innovation is always accompanied by safety, quality, and accountability to patients.

REFERENCES

1. Bộ Y tế (2025) Nghiên cứu phát triển, bảo đảm chất lượng, thử nghiệm lâm sàng và ứng dụng sản phẩm in 3D trong y tế. Cổng thông tin điện tử Bộ Y tế. Available at: https://moh.gov.vn/hoat-dong-cua-lanh-dao-bo/-/asset_publisher/TW6LTp1ZtwaN/content/nghien-cuu-phat-trien-bao-am-chat-luong-thu-nghiem-lam-sang-va-ung-dung-san-pham-in-3d-trong-y-te
2. Nghị định số 96/2023/NĐ-CP quy định chi tiết một số điều của Luật Khám bệnh, chữa bệnh.
3. Thông tư số 32/2023/TT-BYT quy định chi tiết một số điều của Luật Khám bệnh, chữa bệnh.
4. TCVN 7740-1:2007 – Thử lâm sàng trang thiết bị y tế đối với con người – Phần 1: Yêu cầu chung (ISO 14155-1:2003).
5. TCVN 7740-2:2007 – Thử lâm sàng trang thiết bị y tế đối với con người – Phần 2: Kế hoạch thử lâm sàng (ISO 14155-2:2003).