Neurovascular Devices/Interventional Neurology Market: Global Regulatory Landscape

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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

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• 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.
• Lets 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.

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• 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 devices
  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 worlds
  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
  Japans primary medical device
  legislation. Manufacturers are obligated to
  comply with the Acts 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.

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• 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.
• FAQs
• What is interventional neurology?
• A Interventional neurology is a medical
  specialty focused on treating neurological
  conditions using minimally invasive techniques.
  These procedures involve accessing the blood
  vessels of the brain or spine to treat conditions
  such as aneurysms, stroke, and vascular
• malformations.
• Can neurovascular devices help treat strokes?
• A Yes certain devices like stent retrievers are
  used to remove blood clots causing ischemic
  strokes, restoring blood flow to the brain.