Important Information to Stakeholders - Implementation of Advance Notice of Importation Process for Medical Devices
Health Canada is informing stakeholders of the implementation of a process for the advance notice of importation of Medical Devices under section 21.1 and 21.2 of the Medical Devices Regulations (MDR) and under section 3.1 of the Radiation Emitting Devices Regulations (REDR) to permit relabelling of non-compliant medical devices within three months of importation but prior to their sale in Canada.
The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) was ratified by Canada on October 29, 2018. The CPTPP permits the importation of medical devices with non-compliant labels, so long as relabeling is carried out to meet the regulatory requirements of the country of importation prior to sale and within 3 months of importation of the device. This permits the streamlining of medical device and radiation emitting medical device import-export in Canada. Amendments to the MDR and the REDR permitting the conditional importation of medical devices with non-compliant labels will enter into force on December 30, 2018.
If the sale in Canada of a medical device would be lawful after relabelling, the MDR and REDR permit importation, subject to all the following conditions:
- The licenced importer or manufacturer (where the importer does not hold an establishment licence), provides an Advance Notice of Importation (ANI) Form to Health Canada, including sufficient information regarding:
- the manufacturer and the importer of the imported medical device;
- the medical device to be relabelled;
- the labelling correction(s) required; and,
- the Canadian establishment where the relabelling activity will take place.
- If a person other than the manufacturer will be performing the relabelling, the manufacturer must notify the Minister, in writing, of the name of the person in Canada authorised to conduct labelling activities on its behalf.
- The medical device must be relabelled according to the MDR and REDR requirements prior to sale and within three months of the importation date.
The ANI Process applies solely to labelling corrections. All other licensing requirements continue to apply, including that the medical device be: licensed for sale in Canada; imported from a foreign manufacturer or distributor that holds a valid Medical Device Establishment License (MDEL); or, imported and sold through a party in Canada that holds a valid MDEL, unless exempted under S.44(2) of the MDR.
To help ensure the safety of Canadians, Health Canada will continue to conduct compliance and enforcement activities, including targeted compliance monitoring projects, to verify the compliance of relabelled devices being sold on the market, taking appropriate enforcement action, where necessary.
The ANI Process and relabelling requirements apply to medical devices, including the sale or lease of radiation emitting medical devices, imported into Canada that require relabelling prior to sale. Raw material and devices requiring corrective measures beyond relabelling are not in scope.
Advance notice of Importation
When invoking section 21.1 of the MDR or section 3.1 of the REDR, importers that hold a valid MDEL must provide Health Canada with advance notice of each proposed importation. If the importer does not hold a valid MDEL, such as a retailer or healthcare facility, the medical device manufacturer must submit the advance notice to Health Canada. The manufacturer must also identify to the Minister, in writing, the establishment in Canada authorised to relabel the device on its behalf. ANIs will be considered active for up to three months. Medical devices not under an active ANI at the time of importation will not be considered under section 21.1 of the MDR or section 3.1 of the REDR.
Health Canada encourages companies to submit proposed corrected labels with their ANI Form. Labelling corrections must be carried out within three months of the importation date and prior to sale. Please request a copy of the ANI Form by contacting Health Canada at email@example.com. Additional information can be found in the Guidance on Advance Notice of Importation under section 21.1 of the Medical Devices Regulations (MDR) and section 3.1 of the Radiation Emitting Devices Regulations (REDR).
At the border
Upon importation, a medical device covered by a valid ANI is deemed to comply with the advance notice requirements of section 21.1 of the MDR or section 3.1 of the REDR. However, a valid ANI does not guarantee entry of a medical device into Canada. These products remain subject to inspection when referred to Health Canada by the Canada Border Services Agency (CBSA), and any medical device not meeting all requirements of the MDR or REDR may be recommended for refusal by Health Canada, regardless of relabelling. This includes unauthorized devices imported into Canada pending market authorization by Health Canada. A medical device with pending market authorization does not meet the modification or relabelling conditions of section 21.1 of the MDR or section 3.1 of the REDR.
Compliance and Enforcement
Health Canada may conduct compliance monitoring activities to gather information about industry compliance with post-importation relabelling requirements. Companies that do not comply with relabelling requirements may be subject to compliance and enforcement action in accordance with the Compliance and Enforcement Policy for Health Products (POL-0001). Compliance and enforcement action includes, but is not limited to: a stop sale order, refusal at the border, seizure, and/or destruction.
The Medical Devices Compliance Program may be contacted for more information concerning the ANI process: firstname.lastname@example.org
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