Vericert

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 CanadaClass Risk Level Licence Required ExamplesClass I Low Risk MDEL only Bandages, glovesClass II Low-Moderate Risk MDL + MDEL Thermometers, cathetersClass III Moderate Risk MDL + MDEL Syringes, infusion pumpsClass 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

CDSCO Certification Types for Medical Devices
2. Form MD-3 – Application for Manufacturing License for Class A & B Devices
3. Form MD-5 – Manufacturing License for Class A & B Devices Apply to State Licensing Authority (SLA).For domestic manufacturers of low to medium risk medical devices.

4. Form MD-7 – Application for Manufacturing License for Class C & D Devices

5. Form MD-9 – Manufacturing License for Class C & D Devices

Apply to CDSCO Head Office (Central Licensing Authority).
For domestic manufacturing of high-risk devices (e.g., cardiac stents, catheters).

6. Form MD-4 – Application for Loan License for Class A & B

7. Form MD-6 – Loan License for Class A & B Devices

When a manufacturer uses another licensed facility to manufacture.
8. Form MD-8 – Application for Loan License for Class C & D
9. Form MD-10 – Loan License for Class C & D Devices Similar purpose as MD-4/6 but for high-risk categories.1
10. Form MD-11 – Application for Import License for Medical Devices
11. Form MD-15 – Import License for Medical Devices For foreign manufacturers.

Requires appointment of an Authorized Indian Agent.

Requires:

• Free Sale Certificate (FSC)
• ISO 13485
• Device Master File (DMF)
• Plant Master File (PMF)

 

12. Form MD-12 – Application for Import License for IVDs

13. Form MD-16 – Import License for IVD Devices

Specifically for in-vitro diagnostics.

14. Form MD-14 – Application for Testing License

15. Form MD-18 – Testing License to Manufacture for Test or Evaluation

Required for clinical evaluation, R&D, or stability studies.
16. Form MD-17 – Application for Test License for Import
17. Form MD-19 – Test License for Import of Medical Device for Testing/Evaluation
For imported samples not for commercial sale.

18. Form MD-20 – Application for Registration of Notified Body
19. Form MD-21 – Notified Body Registration Certificate

For certification bodies performing audit of Class A & B manufacturers.
20. Form MD-22 / MD-23 – Application for Clinical Investigation of Medical Device

21. Form MD-24 / MD-25 – Permission for Clinical Investigation Applicable for new or investigational medical devices.

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 CanadaClass Risk Level Licence Required ExamplesClass I Low Risk MDEL only Bandages, glovesClass II Low-Moderate Risk MDL + MDEL Thermometers, cathetersClass III Moderate Risk MDL + MDEL Syringes, infusion pumpsClass 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

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 CanadaClass Risk Level Licence Required ExamplesClass I Low Risk MDEL only Bandages, glovesClass II Low-Moderate Risk MDL + MDEL Thermometers, cathetersClass III Moderate Risk MDL + MDEL Syringes, infusion pumpsClass 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

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 CanadaClass Risk Level Licence Required ExamplesClass I Low Risk MDEL only Bandages, glovesClass II Low-Moderate Risk MDL + MDEL Thermometers, cathetersClass III Moderate Risk MDL + MDEL Syringes, infusion pumpsClass 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