Asia
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of medical devices and other healthcare products, has published a FAQ document dedicated to 3D-printed medical devices. The document provides additional clarifications on the applicable...
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical devices manufactured by using the 3D-printing technology. The document is intended to provide additional...
Europe
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on 3D printing of medical devices and components in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). Scope of the MHRA Guidance The present guidance published by...
North America
Recently, there has been a surge in medical products that can be manufactured by the process of additive manufacturing, informally known as 3D printing. While the most common applications are still limited to knee replacements, individually designed implants and drugs...
