Health Canada has recently announced a number of actions they’re taking in the fight against the COVID-19 Pandemic. These actions involve temporary exemptions for the importation of disinfectants/hand sanitizers and fast-tracking Medical Device Establishment Licensing (MDEL) for Class-1 personal protective equipment (PPE).
These products, considered non-prescription drugs are classified as Natural Health Products and are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). Typically, depending on the types of ingredients used, these products normally require either a Natural Product Number (NPN) or a Drug Identification Number (DIN) from the NNHPD. However, as part of what Health Canada is referring to as interim measures, they will facilitate importation of the following:
Health Canada will be expediting applications for all Class 1 PPE MDELs in order to help address the shortage of supplies of these medical devices.
Examples of a Class I PPE:
Health Canada has committed to issuing MDEL’s within 24 hours from the time a complete application has been submitted.
Companies looking to submit an expedited MDEL application should:
For more information about this update, or assistance with disinfectant product importation or Class-1 PPE MDELs, please contact dicentra.