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

The CDSCO Registration Consultant  is responsible for regulating the registration & sale of notified medical devices in India.

We also help companies get the wholesale license to facilitate sale of their products in India.The Central drug standard control organization (CDSCO) is the national regulatory body or licensing authority for Indian pharmaceuticals and medical devices.

CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. The headquarter of the Central Drugs Standard Control Organization is located at New Delhi.

Medical Device Registration and CDSCO approval process In India.

Step1:

• Is your product on the list below of Notified Medical Devices and IVDs which require device registration in India? Blood Component Bags, Blood Grouping Sera, Bone Cements, Cardiac Stents, Catheters, Condoms, Disposable Hypodermic Needles, Disposable Hypodermic Syringes, Disposable Perfusion Sets, Drug Eluting Stents, Heart Valves, IV Cannulae, Internal Prosthetic Replacements, Intra Ocular Lenses, Intra Uterine Devices, IVD Devices for HIV, HBsAG and HCV, Orthopedic Implants, Scalp Vein Sets, Skin Ligatures, Surgical Dressings, Sutures and Staplers, Tubal Rings, Umbilical Tapes.

Step2:

• For medical device or IVD on list above, appoint an India Authorized Agent to interact with the Central Drugs Standard Control Organization (CDSCO) on your behalf.

Step3:

• For medical device or IVD on list above, grant your India Authorized Agent Power of Attorney to manage your registration in India.

Step4:

• For medical device or IVD on list above, file application for Device Registration Certificate to CDSCO using Form 40. Schedules D-1 and D-2 must be included, as well as verification of compliance with US, Canadian, European, Japanese or Australian medical device regulations.

Step5:

• For medical device or IVD on list above, device manufacturers new to India require a Form 45 (New Drug License) in support of the Form 40 application.

Step6:

• For medical device or IVD on list above, obtain Registration Certificate.

Step7:

• Identify your distributor in India.

Step 8:

• Apply for Import License using Forms 15 available from CDSCO. You must identify your chosen distributors on these forms.

Step 9:

• Obtain Import License (Form 15) from CDSCO. License valid for 3 years.
• You are now authorized to market your device in India.

CDSCO Registration:

• cdsco medical devices 
• medical device regulations in India 
• cdsco registration 
• India medical device 
• Indian medical registration 
• medical device registration in India 
• cdsco certificate 
• cdsco online registration 
• cdsco registration process

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

Additional Information:

• Delivery Time: 7 days

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 DevicesApply 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 DevicesApply 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 DevicesWhen a manufacturer uses another licensed facility to manufacture.
8. Form MD-8 – Application for Loan License for Class C & D9. Form MD-10 – Loan License for Class C & D DevicesSimilar purpose as MD-4/6 but for high-risk categories.
10. Form MD-11 – Application for Import License for Medical Devices11. Form MD-15 – Import License for Medical DevicesFor 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 IVDs13. Form MD-16 – Import License for IVD DevicesSpecifically for in-vitro diagnostics.
14. Form MD-14 – Application for Testing License15. Form MD-18 – Testing License to Manufacture for Test or EvaluationRequired for clinical evaluation, R&D, or stability studies.
16. Form MD-17 – Application for Test License for Import17. Form MD-19 – Test License for Import of Medical Device for Testing/EvaluationFor imported samples not for commercial sale.
18. Form MD-20 – Application for Registration of Notified Body19. Form MD-21 – Notified Body Registration CertificateFor certification bodies performing audit of Class A & B manufacturers.
20. Form MD-22 / MD-23 – Application for Clinical Investigation of Medical Device21. Form MD-24 / MD-25 – Permission for Clinical InvestigationApplicable 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

Medical Devices Regulations (

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.