Vericert

Get Health Canada Approval to Sell Medical Devices in Canada To legally manufacture, import, distribute, or sell medical devices in Canada, you must register with Health Canada under one or both of the following license types:

MDL – Medical Device Licence (for Class II, III, and IV devices)

MDEL – Medical Device Establishment Licence (for importers, distributors, and some manufacturers)

At Vericert, we provide end-to-end consulting and registration services to help you comply with Canada's Medical Devices Regulations and access the Canadian market smoothly.

What is an MDL (Medical Device Licence)?

• Issued by Health Canada, the MDL is required for companies intending to sell Class II, III, or IV devices in Canada. Class I devices do not require an MDL but are subject to MDEL.

MDL Services We Offer:

• Device classification assessment
• Health Canada account setup

Preparation of:

• Device Label and IFU (in English & French)
• Safety & Effectiveness data
• ISO 13485:2016 Certificate
• Canadian Medical Device Regulations (CMDR) compliance
• Submission of MDL application to Health Canada
• Ongoing support for license amendments or renewals

What is an MDEL (Medical Device Establishment Licence)?

• An MDEL is required by any company importing, distributing, or selling medical devices in Canada, including Class I devices.

MDEL Services We Offer:

• Establishment classification and eligibility check

Preparation of:

• Quality procedures & SOPs
• MDEL Application form
• Establishment contact and structure details
• Submission to Health Canada and tracking
• Annual renewal and compliance support
• Audit readiness documentation (MDEL holders may be inspected by Health Canada)

Device Classification in Canada

• Class Risk Level Licence Required Examples
• Class I Low Risk MDEL only Bandages, gloves
• Class II Low-Moderate Risk MDL + MDEL Thermometers, catheters
• Class III Moderate Risk MDL + MDEL Syringes, infusion pumps
• Class IV High Risk MDL + MDEL Pacemakers, heart valves
• 100% Health Canada compliant documentation
• ISO 13485 and CMDR expertise
• Affordable support for startups and exporters
• Transparent timelines and fixed pricing
• Support for both foreign and Canadian companies

License Type Form Purpose

Manufacture for Testing Form MD-14 / MD-18 Clinical trials, stability studies, performance evaluation

Import for Testing Form MD-17 / MD-19 Import of unregistered devices for research/demo

We Support:

• Prototype & innovation testing
• Clinical trial supplies

Bio-compatibility and safety evaluations

• Third-party performance and usability studies
• Stability studies and R&D scale production

Required Documents:

• Justification letter for the device
• Device details and intended use
• ISO 13485 certificate
• Testing protocols and lab details
• Agreement with CRO/testing facility (if applicable)

Why Choose Us?

• Fast NSWS account setup and license filing
• Support for Indian and foreign entities
• Liaison with CDSCO and assistance in query response
• Affordable compliance for startups and innovators

License Type Form Purpose

Manufacture for Testing Form MD-14 / MD-18 Clinical trials, stability studies, performance evaluation

Import for Testing Form MD-17 / MD-19 Import of unregistered devices for research/demo

We Support:

• Prototype & innovation testing
• Clinical trial supplies

Bio-compatibility and safety evaluations

• Third-party performance and usability studies
• Stability studies and R&D scale production

Required Documents:

• Justification letter for the device
• Device details and intended use
• ISO 13485 certificate
• Testing protocols and lab details
• Agreement with CRO/testing facility (if applicable)

Why Choose Us?

• Fast NSWS account setup and license filing
• Support for Indian and foreign entities
• Liaison with CDSCO and assistance in query response
• Affordable compliance for startups and innovators

Get Health Canada Approval to Sell Medical Devices in Canada To legally manufacture, import, distribute, or sell medical devices in Canada, you must register with Health Canada under one or both of the following license types:

MDL – Medical Device Licence (for Class II, III, and IV devices)

MDEL – Medical Device Establishment Licence (for importers, distributors, and some manufacturers)

At Vericert, we provide end-to-end consulting and registration services to help you comply with Canada's Medical Devices Regulations and access the Canadian market smoothly.

What is an MDL (Medical Device Licence)?

• Issued by Health Canada, the MDL is required for companies intending to sell Class II, III, or IV devices in Canada. Class I devices do not require an MDL but are subject to MDEL.

MDL Services We Offer:

• Device classification assessment
• Health Canada account setup

Preparation of:

• Device Label and IFU (in English & French)
• Safety & Effectiveness data
• ISO 13485:2016 Certificate
• Canadian Medical Device Regulations (CMDR) compliance
• Submission of MDL application to Health Canada
• Ongoing support for license amendments or renewals

What is an MDEL (Medical Device Establishment Licence)?

• An MDEL is required by any company importing, distributing, or selling medical devices in Canada, including Class I devices.

MDEL Services We Offer:

• Establishment classification and eligibility check

Preparation of:

• Quality procedures & SOPs
• MDEL Application form
• Establishment contact and structure details
• Submission to Health Canada and tracking
• Annual renewal and compliance support
• Audit readiness documentation (MDEL holders may be inspected by Health Canada)

Device Classification in Canada

• Class Risk Level Licence Required Examples
• Class I Low Risk MDEL only Bandages, gloves
• Class II Low-Moderate Risk MDL + MDEL Thermometers, catheters
• Class III Moderate Risk MDL + MDEL Syringes, infusion pumps
• Class IV High Risk MDL + MDEL Pacemakers, heart valves
• 100% Health Canada compliant documentation
• ISO 13485 and CMDR expertise
• Affordable support for startups and exporters
• Transparent timelines and fixed pricing
• Support for both foreign and Canadian companies