25+ Years of Industry Experience
PositiveMD is a non-sterile medical device manufacturer specializing in the compliant assembly of naloxone kits and other regulated emergency response products.
We are fully licensed by Health Canada and certified to ISO 13485:2016, meaning pharmacies, distributors, public health agencies, and organizations looking for naloxone kits, can know our devices are fully compliant with Health Canada. Without relying on temporary exemption orders.
ISO 13485 Certified Quality System
Ensuring full regulatory compliance and manufacturing control.
Health Canada Approved
Medical Device Establishment License – Authorizing production and distribution of regulated devices.
Lot & Expiry
Traceability
Connect2 System – Every component tracked and recorded.
With PositiveMD, you never have to worry about changing regulations or exemption orders every product we manufacture is fully compliant, and Health Canada–licensed.
Confidence in Every Kit.
When it comes to overdose response, there’s no room for uncertainty.
PositiveMD manufactures Naloxone kits in a licensed, audited, and traceable environment that meets Canada’s most stringent medical device standards.
Every kit assembled in our facility is supported by Our ISO 13485 Certification.
Your Licensed Partner for Naloxone and Emergency Kits
Whether you represent a pharmacy chain, health authority, or community program, you can trust PositiveMD medical devices. Our Health Canada licensing and ISO 13485 certification eliminate uncertainty, ensuring your supply chain is compliant, auditable, and reliable.
For Naloxone kit procurement or to discuss partnerships on other medical devices, click below.