Medical Devices Bureau of the Therapeutic Products Directorate (TPD) also known as Health
Canada is the national authority in Canada. Health Canada regulates, monitors and evaluates the safety,
effectiveness and quality of diagnostic and therapeutic medical devices.
The Canadian Regulations called Food and Drugs act, under which, the medical device regulations are set.
All the information about medical device approval process is provided comprehensibly on the “Safe Medical Devices
“page on Health Canada website. The medical device regulations of Canada are extremely close to GHTF/ IMDRF regulations
and similar to the EU requirements. Hence, classification and definition are close to GHTF and EU.
However, the processes at Health Canada are extremely systematic and well established but one of the most stringent in the world.
All medical devices distributed in Canada undergo a combination of scientific review, monitoring, compliance and enforcement activities.
With Partner offices in Canada, Lexium’s team in Canada has the expertise to help you navigate Health Canda’s regulatory requirements and begin
selling your device in Brazil.
A device can be distributed only after receives the appropriate medical device license, it in Canada.
The process of licensing Medical device in Canada includes two types of license in Canada:
- Medical Device Establishment Licensees (MDEL) for import and distribution of all devices and manufacturing Class I medical devices.
- Medical Devices Licenses (MDL) – for class marketing II, III and IV.
- Special Access Program (SAP) – to allow doctors import devices, which are not licensed in Canada for use in emergency or in case
of unavailability of appropriate therapy for a condition.
The device applications has several document requirement. The process of Medical device Marketing approval in Canada includes:
- Classify the Device
- Comply with Quality Requirements
- Submission of a Medical Device License Application in Prescribed Form
- Providing the Class Specific Information of Device
- TPD Review of the Application
- License is issue basis TPD satisfaction on compliance with required regulatory standards /requirements
Post Approval Services
Lexium supports the foreign manufacturers in start to end medical device life cycle management,
including post approval activities such as:
- Post approval change management, modifications to existing medical device
approvals such as addition of new variants, accessories & addition of new
indications of use among others.
- Maintenance of approvals and registration through timely payment of
administrative & registration fees.
- Renewal of License
- Liaison between Health Canada and the manufacturer
- Importation Arrangement
- Regulatory Due Diligence Services
- Official Classification Services
- GMP Certification Services
- MDSAP Certification
- Economic Information Report (EIR) Services
- Device Registration Through Regulatory Pathways
- Translation Services
- Labelling Services
- Distributor Identification & Qualification Services
- Operating Permits and Authorization
- Post Approval Change Management
- License Renewal and Transfer Services
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