Neurovascular Devices/Interventional Neurology Market: Global Regulatory Landscape Neurovascular devices/interventional neurology is a specialized branch of medical technology that focuses on the diagnosis as well as treatment of conditions affecting the blood vessels of the brain and spinal cord. It constitutes minimally invasive procedures performed by skilled neurosurgeons or interventional radiologists in order to address a range of neurological disorders. As per Inkwood Research, the global neurovascular devices/interventional n eurology market is set to grow with a CAGR of 5.23% during the forecast period, 2023-2032. Regulation plays a vital role in the field of neurovascular devices/interventional neurology, ensuring the safety and effectiveness of medical interventions and procedures. Governing bodies in this domain work to safeguard patients from potential health risks, establishing a secure working environment and upholding public health and well-being. Further, regulations are essential for standardizing and supervising neurological devices, ensuring that healthcare bodies provide safe care to all patients and medical professionals. This blog analyzes the global neurovascular devices/interventional neurology market in terms of the regulatory frameworks across major geographical regions.
Role of Regulatory Bodies in Neurovascular Devices/Interventional Neurology North America – The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is responsible for guaranteeing that patients in the United States have prompt access to topnotch, secure, and efficient medical devices. Operating within CDRH, the Division of Neurological and Physical Medicine Devices assesses medical innovations that interact with the central and peripheral nervous system (neurotechnologies), encompassing neurointerventional medical devices employed in stroke treatment. o
Food and Drug Administration (FDA) Premarket Notification [510(k)] – A significant portion of neurovascular devices fall under the Class II classification, making them eligible for the 510(k) pathway. This regulatory route permits manufacturers to demonstrate the “substantial equivalence” of their product to an existing PMA-exempt device already in the market. Successful demonstration of this equivalence allows for marketing approval; in contrast to the PMA process, the 510(k) pathway offers a faster and more cost-effective approach.
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Quality Management System (QMS) – In Canada, manufacturers are required to establish a Quality Management System to ensure the consistent production and regulation of their products according to accepted standards. Moreover, Health Canada often requires