Medical Device Import Process & MDEL Import Agent

Medical Device License SaMD, MDL, MDEL

Importation of Medical Devices

Health Canada strictly regulates the import of medical devices into Canada. Medical devices imported into Canada for sale, with or without a monetary contribution, must meet Health Canada requirements for commercial importation, as outlined in the Food and Drugs Act (FDA) and the Medical Devices Regulations (MDR).

The importation of a medical device that requires direct oversight, operation, or administration by another person is commercial. For instance, commercial importation of medical devices includes shipments to a retailer, distributor, or another commercial establishment. This also includes shipments to independent sales contractors and distributors or health care practitioners for use in their practice.

According to Health Canada guidelines, an importer is any person in Canada, other than the manufacturer of a medical device, who is responsible for the medical device coming into Canada. It is important to note that anyone who imports a medical device into Canada must also meet all applicable regulatory requirements.

The importer must have a valid Medical Device Establishment Licence (MDEL) with the activity of import and ensure that the company from whom they import (foreign distributor) has an MDEL that includes the appropriate licensable activities unless exempted. If medical devices do not conform with Health Canada regulations and requirements, they may be denied entry into Canada and may jeopardize your financial investment.  Importing medical devices into the US can be a complicated process. From assessing requirements to handling paperwork and arranging transportation, there’s a lot to consider.

Register and List Medical Device

Why do you need an MDEL Import Agent?

Save yourself the rigors of meeting the regulatory requirements to import your medical devices into Canada, use an MDEL Import Agent! An MDEL Import Agent resides in Canada, assists in communicating with Health Canada, responds to Health Canada’s questions regarding devices to be imported or already imported into Canada, undertakes mandatory inspections, and meets all regulatory requirements relating to medical device importation and sale in Canada. MDEL Import Agents are legally responsible for medical devices in Canada and have extensive responsibilities under MDR. Check out of blog “Why your business should have a trusted medical device importer.”

When do you need an MDEL Import Agent?

As a foreign company that does not have a presence in Canada and wants to enter the Canadian market, an MDEL Import Agent can register your products in Canada. Else way, a Canadian company may also use an MDEL Import agent especially when you want to offload the legal responsibilities relating to the importation of medical devices to professionals who understand and meet compliance requirements.

FDA UDI and GUDID 510k Medical Device
Benefits of using QIS as your MDEL Import Agent

Importers should ensure that the device they are bringing into Canada is compliant with all the necessary regulations. The costs of non-compliance can be huge – in terms of monetary losses and reputational damage as well.

Save yourself the heavy cost of yearly licensing, yearly compliance, and regulatory requirements – import your devices stress-free! Have the professionals do the heavy lifting of executing the fine print included in regulatory requirements and avoid unnecessary delays and expenses.

We can also assist you with MDEL Registration, Medical Device Classification, IVD Device Registration, and Software as a Medical Device (SaMD) Classification and Registration.

Medical Device Import process

1. Research your market and select a Medical Device

Before you begin the medical device import process, it’s important to do your research. First, assess the market to identify the type of medical device you want to import. Consider factors such as customer demand, potential regulatory hurdles, and the availability of suppliers. You should also research pricing models for similar devices in the US market for comparison purposes. Once you’ve narrowed down your options, select a medical device and make sure you have all the necessary information on hand. This will help ensure a smoother transition through all steps of the import process.

2. Review the regulatory requirements for your country or region

Once you’ve identified the medical device you want to import, you will also have to review the applicable regulatory requirements for your country or region. Different countries and regions may have different requirements that must be met before you can legally market and sell a medical device. For instance, the U.S. requires importers of medical devices to get FDA clearance and a listing. Additionally, it’s important to understand if any local laws apply in regard to product labeling or documentation requirements. Take the time to consult with any applicable regulatory bodies and industry experts before proceeding with your import plan, so there are no surprises down the line.

Medical Device Import process
Medical Device License and Import process MDEL or MDL

3. Prepare your import documentation and ensure compliance with regulations

After the regulatory requirements for your medical device have been identified and met, you should begin preparing the necessary import documentation. Depending on the type of medical device, other documents may be required to obtain clearance from customs to bring your product into the target country. In some cases, special licenses or permits may also be needed. Additionally, you may need to provide certificates of origin and declarations of conformity, which will depend on the laws and regulations in place in each region where you’re importing. Before submitting any documents to customs, make sure all information is accurate and up-to-date as errors can lead to delays or other problems.

4. Understand product classification for Imported Devices

A key part of the process for successfully importing medical devices is understanding the product classification. This can be a complicated task, as different countries have different ways of categorizing such products for regulatory purposes. Inaccurate or misclassified products can end up being denied entry into the country, so it is essential to take the time to understand how your medical device will be classified in each country you are importing into.

Medical Device Import process
Medical Device Import process

5. Follow guidance on labeling and packaging of Imported Medical Devices

When preparing to import medical devices, you must also be aware of the regulations related to labeling and packaging. All must identify information such as the manufacturer, country of origin, product name, and description, and be indicated on both the primary and secondary packages. Additionally, labels should be written in a language understood by those who will use them—often English or the local language. Careful attention should be paid to international labeling conventions and messages prescribed by regulatory bodies.

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