Application for a New Medical Device Licence for a Private Label Medical Device

Contact: Medical Devices Bureau Enquiries

Date: April 2011

1. Name of the Private Label Medical Device

(as it appears on the label)

2. Private Label Manufacturer Information

(as it appears on the label)

Contact Name and Title:

Company ID (if known):

Company Name:

Telephone:
Fax:
E-mail:
Street:
Suite:
P.O. Box:
City:
Province/State:
Country:
Postal/Zip Code:

3. Private Label Regulatory Correspondent Information

(if applicable)

Contact Name and Title:

Company ID (if known):

Company Name:

Telephone:
Fax:
E-mail:

Street:
Suite:
P.O. Box:

City:
Province/State:
Country:
Postal/Zip Code:

4. Original Manufacturer Information

Contact Name and Title:

Company ID (if known):

Company Name:

Telephone:
Fax:
E-mail:
Street:
Suite:
P.O. Box:
City:
Province/State:
Country:
Postal/Zip Code:

5. Information on Medical Device Manufactured by the Original Manufacturer

Name of Device:

Device Class (II, III or IV):

Licence No.:

Quality System Certificate Number:

Name of Registrar:

6. Licence Application Type

(check one only)

• Single device
• Test kit
• Medical device group
• System
• Medical device family
• Medical device group family

7. Identifier of Private Label Medical Device

(include an identifier for each device or medical device group listed)

• Name of device, components, parts and/or accessories as per product label
• Identifier for Private Label Medical Device (bar code, catalogue, model or part number)
• Corresponding Identifier for Medical Device Manufactured by Original Manufacturer (bar code, catalogue, model or part number)
• Corresponding Device ID as it appears on the Original Manufacturer's Medical Device Licence
• Preferred Name Code (For Health Canada Use Only)

8. Attestations

I, the private label manufacturer, hereby attest that:

1. I have included in this application a Declaration of Compliance with the Medical Devices Regulations signed by a senior official of the the private label manufacturer, in the format prescribed in Appendix 1 of the Guidance for Industry - How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device.
2. I have included in this application a Letter of Authorization (original letter only) signed by a senior official of the original manufacturer, in the format prescribed in Appendix 2 of the Guidance for Industry - How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device;
3. I have included in this application a copy of the device label; and
4. I understand that all of the provisions of the Food and Drugs Act and Medical Devices Regulations apply to a private label medical device and private label manufacturer and are the responsibility of the private label manufacturer.

I, the private label manufacturer, also certify that the information and material included in this medical device licence application is accurate and complete.

Name of Private Label Manufacturer's Authorized Signing Official:
Signature:
Title:
Date: