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).

Temporary Exemptions for Importation of Disinfectants and Hand Sanitizers

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:

• Products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g., English-only labeling; Hand sanitizers that meet the NNHPD’s Antiseptic skin cleansers monograph requirements and have a DIN or NPN for personal commercial use or for a different dosage form).
• Products that are not authorized for sale in Canada but are authorized or registered in the United States or an MRA (Mutual Recognition Agreement) country.

Expedited Medical Device Establishment Licences (MDELs) for Class-1 Personal Protective Equipment (PPE)

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:

• N95 facepiece respirators
• Gowns
• Masks
• Face shields
• Isolation units, pods or rooms intended for transporting infected and contaminated patients
• Nasal pharyngeal swabs

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:

• Complete the MDEL Form on Health Canada’s website
• Submit their complete form to: hc.mdel.application.leim.sc@canada.ca

For more information about this update, or assistance with disinfectant product importation or Class-1 PPE MDELs, please contact dicentra.