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 neurology 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 top-notch, 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. 

• • 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.

• • 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 compliance with the ISO 13485 standard for maintaining the optimal quality of medical devices.

Market Position: As per Inkwood Research, the North America neurovascular devices/interventional neurology market is set to progress with a CAGR of 5.39% between 2023 to 2032.

• Europe –

In the European Union (EU), medical devices must undergo a conformity assessment in order to demonstrate they adhere to legal requirements. This measure ensures that devices and equipment are safe and perform as intended. While regulated at the EU Member State level, the European Medicines Agency (EMA) is closely engaged in the regulatory process. 

Let’s take a closer look from a country-level perspective:

• • Unique Device Identification – In Spain, medical devices, particularly neurovascular devices, are required to carry a Unique Device Identification (UDI) code under the IVDR as well as MDR. Moreover, these devices are identified and tracked using the UDI throughout their lifecycle.

• • Medical Device Regulation – A medical device cannot be put on the market in Great Britain unless it has a UKCA or a CE marking. A CE marking demonstrates that the medical device, encompassing neurovascular devices, also complies with the relevant EU medical device regulations and that the manufacturer has checked that the product meets ‘EU safety, health or environmental requirements.’ These regulations delineate the requirements for performance and safety standards that medical devices must meet prior to their market availability.

• • UK Medicines and Healthcare Products Regulatory Agency (MHRA) – In June 2022, the United Kingdom MHRA announced new plans to enhance patient safety by strengthening the regulation of medical devices. These include providing assurance to the public and patients regarding the performance as well as safety of the highest-risk medical devices, including those that require implantation. 

• • Conformity Assessment – Manufacturers of neurovascular devices in France must undergo a conformity assessment process to demonstrate compliance with relevant regulations. This assessment evaluates aspects such as design, manufacturing processes, clinical data, and others to ensure the device’s performance and safety.

Market Position: Inkwood Research estimates that the Europe neurovascular devices/interventional neurology market is anticipated to capture a revenue share of 26.16% by 2032.

• Asia-Pacific –

Despite Asia having 60% of the world’s population and providing large market potential, Asian healthcare expenditure constitutes only 15% of the global healthcare expenditure. The rapidly aging population and the increasing prevalence of chronic diseases are among the key drivers contributing to the rise in total healthcare spending on medical devices, including neurovascular devices, in the region. Accordingly, several countries in the Asia-Pacific have implemented policies and programs to reduce regulatory burdens, while improving the quality as well as cost-effectiveness of present regulations. 

Some of these are – 

• • National Medical Products Administration (NMPA) – In China, the NMPA reviews the registration application and accompanying documentation, conducting inspections as necessary. Once the product fulfills all regulatory and safety criteria, it receives approval for marketing and sales in China.

• • Pharmaceutical Affairs and Medical Devices Act (PMDA) – The PMD Act serves as Japan’s primary medical device legislation. Manufacturers are obligated to comply with the Act’s standards, encompassing quality management, safety, and post-market surveillance.

• • Central Drugs Standard Control Organisation (CDSCO) – The CDSCO, under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, is the National Regulatory Authority (NRA) of India. CDSCO and state regulators are jointly responsible for granting licenses for specialized categories of critical drugs. 

Market Position: The Asia-Pacific neurovascular devices/interventional neurology market is projected to be the fastest-growing region, progressing with a CAGR of 5.46% from 2023 to 2032.  

As demonstrated, a robust regulatory framework is essential to standardize and oversee neurovascular interventions, ensuring that practitioners and facilities adhere to established guidelines. They also help provide secure and reliable care to patients undergoing neurovascular procedures, thus paving the way for the notable growth of the global neurovascular devices/interventional neurology market over the upcoming years.

By Shruti Vanjare