Three-dimensional printing of medical devices

In this context, these non-binding guidelines establish recommendations and considerations regarding design and manufacturing processes, material control and quality assurance, among other aspects, for the use of this technology in the manufacturing or production of medical devices. In this sense, it is relevant to mention that 3D printing also encompasses the development of software as a medical device (SaMD),[2] ie, software designed to be used for one or more medical purposes and that fulfils these purposes without being part of the hardware of a medical device.

Such software can run on hardware and software resources that are not specifically designed for medical use. ANMAT has issued a separate non-binding set of guidelines regarding the development of SaMD, which outlines the technical considerations and key regulatory issues associated with these innovative designs and manufacturing processes.

In light of the above, and despite the absence of specific regulations for medical products manufactured using 3D printing technology, these products must still comply with the general requirements for registering and marketing a medical device in Argentina, as established in ANMAT Disposition No 64/2025 and No 9688/2019. These medical devices must also comply with the good manufacturing practices set by ANMAT.

Innovative 3D printing techniques

There have been some interesting advances regarding 3D printing in Argentina in recent years. For instance, in 2023, researchers from the National University of Cordoba and the National Scientific and Technical Research Council (Consejo Nacional de Investigaciones Científicas y Técnicas or CONICET) developed and patented a melting solidification printing process (MESO-PP), which has proven to be quite successful, that enables printing at low temperatures without the use of solvents. In particular, the process uses materials already widely applied in regard to pharmaceutical technology, so MESO-PP can be considered an excellent alternative for different pharmaceutical applications. In summary, this technique aims to respond to the demand caused by the shortage of orphan drugs. The MESO-PP still lacks ANMAT’s approval.

3D printing and patents

In December 2023, the National Institute of Industrial Property (Instituto Nacional de la Propiedad Industrial or INPI) patented a laryngoscope designed by the National Atomic Energy Commission (Comisión Nacional de Energía Atómica or CNEA) in collaboration with the National University of Tres de Febrero (La Universidad Nacional de Tres de Febrero or UNTREF).[3]

Both institutions have exclusive rights to manufacture, use, offer for sale, sell and import the technology for a period of 20 years.

The need to create the device arose during the Covid-19 pandemic, to cater to the unprecedented number of patients who required endotracheal intubation.

The novelty of this device lies in its design and development, which has led to improved speed and efficiency in regard to the procedure. The laryngoscope is manufactured using 3D printing technology and is made out of a material suitable for medical use, endorsed by both the World Health Organization (WHO) and the US Food and Drug Administration (FDA). As of today, it still lacks ANMAT’s approval.

Pioneers in the field of 3D printing

Raomed,[4] a company based in the province of Córdoba, was the first company in the country to be authorised by ANMAT to develop and manufacture implants. The company produces between 1,000 and 1,500 implants a year using 3D printing involving titanium or biocompatible polymers for neurosurgery, maxillofacial surgery, thorax, traumatology and orthopaedics.

The National Institute of Industrial Technology’s (Instituto Nacional de Tecnología Industrial or INTI) assistance has proven to be crucial in the manufacturing of implants, since it provided the technology required to ensure that each part complies with the highest international standards.

Raomed is currently developing a program aimed at establishing and implementing an International Patient-Specific Implant (PSI) Registry to collect outcome, safety, manufacturing and cost data and develop best practice guidelines that will provide a solid foundation for PSI technology to successfully grow and reach its full therapeutic potential.

ANMAT’s involvement in 3D printing

In March 2025, ANMAT participated as an Observer Member in the 27th meeting of the International Medical Device Regulators Forum, held in Tokyo, Japan. During the forum, one of the working groups discussed how manufacturing processes for medical devices are increasingly shifting closer to the point of care, such as 3D printing in hospitals offering numerous advantages for both patients and healthcare professionals.[5]

This reflects ANMAT’s growing interest in integrating and embracing 3D printing technology for the manufacturing of medical devices, recognising its numerous advantages.

Conclusion

Technological advances in recent years have been highly beneficial to human medicine. In Argentina, ANMAT has shared its perspective on the importance of emerging technologies for public health. The use of 3D printing technology in the development of medical devices has been steadily growing in recent years. As advancements continue, the adoption of this technology is expected to further enhance patient care, improve medical device accessibility and drive innovation in the healthcare sector.

Notes