Cleared
Certified
& MDR
Manufacturing
The video laryngoscope in Canada has moved from a specialist technique to a mainstream component of airway management across operating rooms, emergency departments, intensive care units, and prehospital services. According to the Canadian Airway Focus Group (CAFG) updated consensus guidelines, published in the Canadian Journal of Anesthesia, most studies comparing video laryngoscopy with direct laryngoscopy indicate a higher first attempt and overall success rate with video laryngoscopy and lower complication rates. Resources allowing, the CAFG now recommends use of video laryngoscopy with an appropriately selected blade type to facilitate all tracheal intubations.
AstraVue provides a complete video laryngoscope in Canada with ISO 13485 certification, FDA clearance, CE marking, and MDR compliance. This page is a reference for Canadian clinicians evaluating systems, procurement teams requiring regulatory documentation, and distribution partners looking to bring the AstraVue video laryngoscope in Canada to market.
Reusable Devices
Disposable Devices
Mini Monitors
Accessories
Reusable camera handle with disposable blade attachments. A cost-effective hybrid option for high-throughput wards and surgical centers.
Fully disposable single-use units including the integrated camera. Suited to emergency departments and ICUs where infection control and speed are priorities.
AstraVue is backed by Goldstar Medical’s 40+ year manufacturing legacy and holds full FDA clearance, CE marking, MDR compliance, and ISO 13485 certification. Our range spans from neonatal through adult hyperangulated configurations, designed to cover the full spectrum of patient populations encountered in Canadian hospital practice. Full blade size specifications are available on request from the AstraVue team.
Surgical-grade stainless steel, fully reusable and autoclavable. Designed for operating rooms with established reprocessing workflows.
All AstraVue blade systems connect to a single universal 4-inch HD touchscreen monitor — with 120 minutes of battery life and mini-HDMI output for connection to larger displays in teaching hospitals and simulation centers.
The CAFG guidelines, developed by a multidisciplinary group of anesthesia, emergency medicine, and critical care physicians across Canada, represent the most current national clinical authority on airway management practice. Prior to airway management, a documented strategy should be formulated for every patient based on airway evaluation, with bedside examination seeking predictors of difficulty with face-mask ventilation, tracheal intubation using video or direct laryngoscopy, supraglottic airway use, and emergency front of neck airway access.
Video laryngoscopes use an integrated blade-tip camera connected to an external monitor, allowing indirect visualisation of the glottis without requiring direct line-of-sight alignment. This is particularly valuable in patients with limited neck mobility, obesity, trauma, or anatomical variations that restrict conventional direct laryngoscopy. The CAFG guidelines specifically endorse hyperangulated blade video laryngoscopy as a recommended option when difficulty is encountered with standard geometry blades. For full clinical guidance, refer to the CAFG Part 1 guidelines on the Canadian Journal of Anesthesia and CAFG Part 2 on anticipated difficult airway management.
Any video laryngoscope in Canada is regulated under the Food and Drugs Act and Medical Devices Regulations administered by Health Canada. Video laryngoscopes are classified as Class II medical devices and require a Medical Device Licence (MDL) prior to commercial sale or distribution in Canada.
Health Canada requires manufacturers to demonstrate compliance with the Medical Device Single Audit Program (MDSAP), which incorporates ISO 13485 as its quality management framework. ISO 13485 certification on its own is not sufficient for the MDL application process in Canada. MDSAP participation is held by AstraVue’s manufacturing partner Goldstar Medical.
In addition, any person importing or distributing medical devices in Canada must hold an active Medical Device Establishment Licence (MDEL), which is a separate licence from the product MDL and must be held by the Canadian importer or distributor.
AstraVue devices hold the following certifications relevant to Canadian procurement:
Full certification documentation, ISO 13485 certificates, and device specifications are available on request to support Health Canada MDL and MDEL application processes.
AstraVue is actively seeking its authorized distribution partners for the video laryngoscope in Canada. According to Precedence Research, the global video laryngoscope market is valued at USD 986.92 million in 2025 and projected to reach USD 5,195.87 million by 2035, growing at a CAGR of 18.07%. North America consistently holds the largest regional share at over 40% of global revenue, making Canada a strategically important and commercially active territory for distribution partners entering this space.
The timing is also clinically driven. The Canadian Airway Focus Group now recommends video laryngoscopy for all tracheal intubations where resources allow, placing Canadian hospitals under increasing institutional pressure to evaluate and upgrade their airway management systems. This creates a clear and growing procurement pipeline for a qualified distribution partner.
Distributing a video laryngoscope in Canada requires a Canadian MDEL holder as the legal importer. Foreign manufacturers without a physical Canadian presence must work through a licensed Canadian MDEL holder, making the local distribution partner a regulatory requirement for market entry — not simply a commercial preference. AstraVue will support its Canadian distribution partner through the MDL and MDEL process with a complete documentation package including MDSAP-aligned ISO 13485 certificates, device technical files, and FDA clearance records.
AstraVue Canadian distribution partners receive:
To discuss distribution partnership opportunities, request regulatory documentation, arrange a product demo, or obtain pricing for Canadian procurement:
Email: sales@astra-vue.com
Phone: +971 54 406 9599
Website: astra-vue.com/contact-us
AstraVue responds to all Canadian distribution and procurement inquiries within one business day.
Our global network of authorized distributors provides comprehensive support to healthcare professionals. For product inquiries, contact your local distributor. For distribution opportunities and partnership inquiries, contact us directly.
Yes. AstraVue video laryngoscopes in the USA hold FDA 510(k) clearance and meet all US requirements for commercial distribution and clinical use. Full clearance documentation is available on request.
Our products meet global standards including FDA, CE, MDR, and ISO 13485 certifications, ensuring compliance with international healthcare regulations.
If we have stock available, delivery can be made within 1 week. If stock is not available, lead times may extend up to 20 weeks (approximately 5 months)
The AstraVue range spans neonatal through adult hyperangulated configurations. Full size specifications are available directly from the AstraVue team on request.
The Pro blade is fully disposable including the integrated camera, requiring no reprocessing. The Lite system uses a reusable camera handle with disposable blade attachments, reducing per-use cost while maintaining single-use infection control for the patient-contact components. For more details, read this blog.
Yes. AstraVue is actively expanding its authorized US distribution network. We are seeking qualified partners with established hospital and surgical center relationships and experience in Class II medical device distribution. Market exclusivity is available in defined territories. Contact sales@astra-vue.com to begin a conversation.
Yes. The AstraVue universal monitor includes mini-HDMI output, allowing connection to larger bedside or wall-mounted displays for resident training, simulation, and case review sessions.
The monitor provides 120 minutes of continuous operation and is compatible with all AstraVue blade configurations, including Pro, Lite, and Ultra across all size variants.
