Resolve Digital, a Canada-based developer of intelligent cannabis solutions and innovative technologies, today announced the first of its family of smart vaporizers, the Resolve MD, has been approved by Health Canada for a Medical Device License (“MDL”) for cannabis use. This represents the first cannabis-related medical device license issued under Canada’s new regulatory system.
MDL ensures the safety, effectiveness and quality of medical devices in Canada by a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process. By receiving its license, the Resolve MD demonstrates it is fully compliant with Health Canada’s Medical Device Regulations, including satisfying medical device, biological and electrical standards throughout the design and manufacturing of the device.
Through this process Resolve satisfied the strict regulatory standards set by Health Canada to obtain a Medical Device Establishment License (“MDEL”). MDEL provides Health Canada approval for Resolve to distribute the Resolve MD for medical purposes. It is separate from MDL and is issued for the purpose of importing and selling medical devices for human use in Canada. The MDEL is issued by the Inspectorate after the establishment has met all the regulatory requirements required for a medical device license.
“For physicians and cannabis patients to be more comfortable with using medical cannabis, there’s a need to make dosing easier and more transparent,” said Dr. Amol Deshpande, a member of Resolve’s Scientific Advisory Board. “Licensed medical devices, such as Resolve’s medical vaporizer, are focused on filling the void for consistent and standardized inhalational dosing for the medical cannabis industry.”
The first of a family of medical cannabis vaporizers that are anticipated to be licensed by Health Canada, the Resolve MD is a smart vaporizer that assists the patient in taking control of their healthcare, utilizing technology that ensures consistent dosing and a professional experience. To make usage of Resolve MD as easy as possible for the patient, the Company is partnering with licensed producers to pre-fill proprietary pods with pre-selected cannabis formulations that are then simply inserted into the device. Beyond devices, Resolve is also developing an app that assists patients in capturing data on medical conditions, prescriptions, family history, lifestyle, and effectiveness per dose, then utilizes those data points to improve the medical cannabis treatment experience for patients and caregivers.
“We’re excited that our family of Resolve devices will be soon available to medical cannabis patients in Canada, and approval from Health Canada for the Resolve MD is a crucial step in providing alternative pathways for patients and health care providers in the treatment of a variety of medical conditions with consistency in dosing,” said Rob Adelson, CEO of Resolve. “Quality control is crucial for any medical device, and we’re pleased that Health Canada has certified that our device meets their high standards.”
Building on this approval by Health Canada, Resolve intends to obtain similar certifications elsewhere in the world starting later this year. In particular, the Company is especially interested in the European market, which a recent report launched at the Davos World Economic Forum indicated could be the world’s largest medical cannabis market within 5 years. (The European Cannabis Report, 4th Edition. Prohibition Partners. January 2019).