Registrations & Approvals: Medical Devices
In Canada, medical devices are regulated under the Food and Drugs Act, and
include health or medical instruments used in the treatment, mitigation,
diagnosis or prevention of a disease or abnormal physical condition.
The Therapeutic Product Directorate (TPD) is given authority by The Food and
Drugs Act to monitor and assess the safety, effectiveness and quality of
diagnostic and therapeutic devices through a combination of pre-market
review, post-approval surveillance and quality systems in the manufacturing
process.
All medical devices are separated into four categories based
on the risk associated with their use. Of the four classes, Class I devices
present the lowest potential risk while Class IV devices present the
greatest potential risk. Class II, III and IV devices must receive
authorization prior to being sold, which is obtained through a Medical
Device License (MDL). Although Class I devices do not require an MDL, they
are monitored through an Establishment License. An Establish License ensures
that the TPD is aware of the identity of establishments that are selling or
manufacturing devices, and requires them to provide assurance that
regulatory requirements related to post-production activities have been met.
TSG’s consultants work with companies to provide regulatory guidance on medical devices and prepare applications for approval. We help obtain Establishment Licenses for Class I devices, MDLs for Class II, III and IV devices, and assist with the various components of an approval application, including label development, identifying data requirements, locating laboratories for study generation, preparing manufacturing description and communicating with TPD.
For foreign companies importing medical devices into Canada, a Canadian registration agent is required. A registered agent, such as TSG Canada, acts as a registered address of the corporation in Canada. TSG Canada provides this registered address for the receipt of service of government filings – and sometimes legal documents - and acts as a liaison for government agencies. Acting as the registered agent, we forward all documents and correspondence to our clients.
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| Key Contacts | |
 Laurie Tyo |
 Saadia Eltayeb |
 Robert Stewart |
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TSG’s consultants are highly knowledgeable of the registration requirements for disinfectants regulated by both PMRA and TPD. TSG provides comprehensive product registration services, from determining data obligations and developing compliant labels, to compiling and submitting the registration application.
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TSG has offices throughout North America and Europe, including Sacramento, CA, Washington, DC, Canada, United Kingdom, Spain and Slovenia. Through these locations and our affiliates, TSG works with companies in 36 countries worldwide including China, Japan, Australia, New Zealand and Latin America.
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