19 Nov 2018
Canada to Allow Relabelling of Medical Devices after Importation
Canada has amended its regulations for medical devices to (i) permit the manufacturer or supplier of an imported medical device to correct non-compliant labels by relabelling the device after importation but prior to sale, and (ii) clarify establishment licencing requirements for Class I medical device manufacturers and distributors of all device classes located outside Canada. The relabelling flexibility is a requirement of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership, which is slated to enter into force on 30 December with respect to Canada and the six other countries that have ratified the agreement to date. According to Canadian authorities, this allowance will streamline the process for importing medical devices, including radiation emitting devices, and facilitate the import-export activities for medical device manufacturers and distributors.
In the context of permitting relabelling of devices not in compliance with labelling requirements after importation, Health Canada needs to ensure it has clear authorities and sufficient regulatory tools to exercise oversight over regulated parties choosing to relabel their products in Canada. Oversight is exercised through the issuance of a product or an establishment licence to monitor the compliance of the medical device industry with Canadian regulatory requirements. Class I devices (lower risk) do not require a product licence. In most cases, compliance of these devices with Canadian regulatory requirements is monitored through the importer or the distributor in Canada who holds a medical device establishment licence (MDEL). However, Canadian retailers and healthcare facilities importing medical devices are not required to hold an MDEL. When foreign manufacturers of Class I devices and distributors of all classes sell directly to a Canadian retailer or a healthcare facility, the issuance of an MDEL is the only mechanism for the regulator to know the identity of these entities located outside Canada and to assess their compliance with Canadian regulatory requirements.
Under the Food and Drugs Act, Health Canada has long issued MDELs to foreign Class I manufacturers and distributors of all device classes located outside Canada to permit them to import and sell a device in Canada. Permitting relabelling of devices after importation highlights an existing issue with respect to the clarity of current establishment licencing requirements under the MDR for foreign Class I manufacturers and all classes of distributors located outside Canada. Canadian authorities believe that amending the MDR to permit relabelling of devices after importation provides an opportunity to clarify that the requirement to hold an MDEL for importing and selling a device in Canada also applies to foreign Class I manufacturers and distributors of all device classes located outside Canada, even when they sell directly to a retailer or a healthcare facility in Canada.