Medical devices with a medium (e.g., sterile injectable medical devices), high (dental implants, stents), or very high (implantable pacemakers, absorbable suture material) potential risk of use are subject to inspection. The national regulatory agency inspects not only the functioning of the quality management system of medical devices but also evaluates the measures taken by the manufacturer of medical devices to ensure their safety, quality, and effectiveness, including monitoring the products already in the post-registration period.
