Single Window Initiative (SWI) - Survival Guide for Health Canada (HC) Medical Devices program

The new SWI landscape

The Single Window Initiative means several changes for importers:

• how you need to submit documentation is in flux;
• when that documentation is needed has changed; and
• which documentation is required is also shifting.

Our goal is to help you understand what is expected for the new “how, when, and what” of SWI requirements relating to the items you ship. These updates guide importers through specific commodities or categories of commodities, and the Participating Government Agencies (PGAs) that are affected.

How, when, and what

• Single Window Initiative requires all import documentation to be prepared and submitted before the shipment reaches customs.
• SWI is a new way of submitting documentation. All docs will be submitted using the Integrated Import Declaration (IID). Some of the requirements for how you submit are changing. For example: some documents that needed to be faxed now require an uploaded electronic image or just the document number.
• There may be changes to which documents are required under SWI.
• The launch date of SWI is still unknown, but it’s time to get proactive and adjust your workflow to ensure paperwork is ready before you ship.

Why importers need to know

Under the new SWI, it’s important that you understand which Participating Government Agencies (PGAs) are regulating your products. Some products are regulated by multiple PGAs, and the PGAs regulating your products may have changed under SWI. Additionally, each PGA and the CBSA can issue penalties for incorrect and missing documents. Understanding what information and documentation is needed for clearance will make the clearance process into Canada smoother and more efficient.

Health Canada (HC) Medical Devices program

The SWI data elements required for release of medical devices include:

Intended end use

The licenses and documents required for a medical device are dependent on the intended end use of that medical device:

• Human therapeutic use
• Investigational testing
• Special access or custom made
• Research and development
• Trade shows/exhibitions
• Other

Canadian product category

For medical devices, the product category is the class of the medical device. Please refer to Health Canada’s Guidance For Industry page to assist in determining the class of the device:

• Class 1
• Class 2
• Class 3
• Class 4

Document type

The class of medical device combined with the intended end use establishes what LPCO (License, Permits, Certificates, Other) documentation is required:

• Human therapeutic use, class 1 device: Establishment license
• Human therapeutic use, class 2, 3, or 4 device: Establishment license and medical device license
• Investigational testing, class 1 device: No documentation
• Investigational testing, class 2, 3, or 4 device: Device letter of authorization (LOA)
• Special access or custom made, class 1 device: No documentation
• Special access or custom made, class 2, 3, or 4 device: Device letter of authorization (LOA)
• Research and development, all device classes: No documentation
• Trade show/exhibitions, all device classes: No documentation
• Other, all device classes: No documentation

Document reference number

Although a copy of the license is not mandatory at time of release, it may be requested:

• Establishment license: Establishment license number required
• Medical device license: Medical device license number required
• Device letter of authorization: Device letter of authorization (LOA) number/request required

Importer contact information

Health Canada requires contact information for all imports. The importer’s name, telephone number, or email address is required for release of Medical Devices.

Exception process

Medical device establishment license exemption. Retailers, health care facilities and manufacturers that are eligible for an exemption to the establishment licensing requirement must indicate their status.

GTIN and UDI number

Medical devices can be identified through their GTIN (global trade identification number) GS1 asset identifier or UDI (unique device identifier) number. These are not required to be submitted, but will give CBSA a clearer identification of the product.

Brand name

The brand name of the commodity must be provided.

Although the below elements are not mandatory for the release of the commodity, they may be asked for and should be supplied:

• Model number: the model number may be required
• Manufacture date: the manufacture date may be required
• Batch/lot number: the batch and lot number may be required

For SWI, being proactive is your best strategy—gather all your information and documentation as far in advance as possible. Importers who know the requirements for the products they’re importing, and understand the new processes under SWI, will have a much smoother import experience.

As you adjust to the new requirements and workflow of the Single Window Initiative, we're here to help. Our customs team is ready to help you understand the SWI and its new requirements for your commodities—contact us today!

SWI. It's what we do.