Document Number C1053 Rev.

Effective Date: 04-AUG-2022 Page 1 of 4

Title: Canadian Device License Procedure

1.0 PURPOSE
1.1 This procedure provides guidelines for maintaining Medical Device License (MDL) and
Medical Device Establishment License (MDEL) registration with Health Canada.
2.0 SCOPE
2.1 This procedure applies to all medical devices to be sold or advertised for sale in Canada and
Young Innovations’ (YI) sites conducting such activities or holding medical device licenses in
Canada.
2.2 Risk Based Approach: This procedure addresses the risk associated with not maintaining
a program to manage device licenses for products distributed in Canada and the
documentation and communication of significant changes, which could result in enforcement
actions, and lack of compliance to Canada’s medical device regulations.
3.0 REFERENCE DOCUMENTS
3.1 Canadian Medical Devices Regulations – SOR/98-282
3.2 Guidance Document: How to Complete the Application for a New Medical Device License
(Effective Date 2020/04/01)
3.3 Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell
Licensed Medical Devices (Effective Date 2013/11/04)
3.4 Application for a New Medical Device License
3.5 Application for an Amendment to a Medical Device License
3.6 F1C1053 CMDR Safety and Effectiveness Requirements Checklist
4.0 DEFINITIONS
4.1 CMDR: Canadian Medical Device Regulations
4.2 EMDD: European Medical Device Directive
4.3 Significant Change: A change that could reasonably be expected to affect the safety or
effectiveness of a medical device. It includes a change to any of the following:
4.3.1 The manufacturing process, facility or equipment;
4.3.2 The manufacturing quality control procedures, including the methods, tests or
procedures used to control the quality, purity and sterility of the device or of the
materials used its manufacture;
4.3.3 The design of the device, including its performance characteristics, principles of
operation and specifications of materials, energy source, software or accessories;
4.3.4 The intended use of the device, including any new or extended use, any addition
or deletion of a contraindication for the device, and any change to the period used
to establish its expiry date.
4.4 Contraindication: Situations where the device should not be used because the risk of use
clearly outweighs any reasonably foreseeable benefits.

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 Document Number C1053 Rev. F

Effective Date: 04-AUG-2022 Page 2 of 4

Title: Canadian Device License Procedure

4.5 Private Label Medical Device: A medical device that is identical in every respect to a
medical device manufactured by an original manufacturer and licensed by Health Canada,
except that the device is labelled with the private label manufacturer’s name, address and
product name and identifier.
5.0 RESPONSIBILITIES
5.1 The Regulatory Affairs (RA) Coordinator or designee is responsible for filing all
documentation in the appropriate regulatory files. The RA designee is responsible for
completing the application process for device licensing and device renewals for Health
Canada and for change notification.
5.2 The signing official is responsible for reviewing and signing applications.
6.0 PROCEDURE
6.1 All sites selling medical devices in Canada, with or without a distributor, must hold a current
MDEL. MDEL is a permit for the company/distributor/importer itself.
6.2 A MDL is required for sites selling Class II, III, or IV medical devices in Canada. The MDL is
a product approval. Canada's MDL is comparable to the US FDA 510(k) process. All
medical devices Class II or higher according to the CMDR are required to be licensed prior
to being sold or imported in Canada.
6.3 Regulatory authorities will be kept informed in accordance with applicable regulatory
requirements in the event of any significant complaints (as defined by the country’s
regulations), adverse events, or field safety notices, and issue notifications regarding any
updates to the technical files that might affect the safety, quality, or efficacy of our product.
Additionally, any new or updated certificates will be sent to applicable governments. The
reporting guidelines follow those of the local authorities. Common means of communication
include, but are not limited to, telephone or email. A decision not to communicate to a
regulatory authority for issues noted above shall be documented with a justification.
6.4 An application for license or amendment application must be completed and submitted to
Health Canada for all Significant Changes. In addition, if the manufacturer proposes to make
one or more of the following changes, the manufacturer shall submit to the Minister, in a
format established by the Minister, an application for a MDL amendment.
6.4.1 In the case of a Class III or IV medical device, a significant change;
6.4.2 A change that would affect the class of the device;
6.4.3 A change in the name of the manufacturer;
6.4.4 A change in the name of the device;
6.4.5 A change in the identifier of the device, including the identifier of any medical
device that is part of a system, test kit, medical device group, medical device
family or medical device group family;
6.4.6 In the case of a Class II medical device, a change in the medical conditions,
purposes or uses for which the device is manufactured, sold or represented.

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 Document Number C1053 Rev. F

Effective Date: 04-AUG-2022 Page 3 of 4

Title: Canadian Device License Procedure

6.5 The application for an amendment can be found online. Using the product labeling and
referencing the CMDR and the guidance document on how to complete the application for a
new medical device license, complete the required elements in the license application.
6.6 Review the device technical file and determine if the required elements are present to
address the safety and effectiveness requirements of the CMDR according to: C7003, Risk
Analysis; CMDR Part I Sections 10 through 20. Devices being introduced into Canada must
have documented safety and effectiveness requirements recorded in F1C1053.
6.7 The signing official must review and sign the application.
6.8 Complete the fee forms.
6.9 Obtain copies of the ISO 13485 certificates.
6.10 Complete the License Application Disclosure Request.
6.11 Send the appropriate completed license application, the fee forms, the method of payment,
the ISO certificates, and the License Application Disclosure Request to Health Canada. Use
the address provided on the license application form guidance documents.
6.12 Annual review of MDEL: Before April 1st of each year, the RA designee shall furnish Health
Canada with completed applications according to section 46(1) of the CMDR confirming all
information and documents are still correct in relation to the establishment license.
6.13 Annual MDL renewal: Before November 1st of each year, the RA designee shall furnish
Health Canada with a signed statement according to Section 43 of the CMDR confirming all
information and documents are still correct in relation to all company licenses. Refer to
Guidance for Industry: Annual MDL Renewal and/or MDL Renewal and Fees for the Right to
Sell Licensed Medical Devices.
6.14 If a new or modified quality management system certificate is issued in respect to a licensed
medical device, the RA designee shall submit a copy to the Minister within 30 days after it is
issued.
6.15 If a product is discontinued in Canada, the RA designee shall inform Health Canada within
30 days and provide any required amendments to the MDL, if applicable.
6.16 Private Label Licenses
6.16.1 YI must obtain a license as “Private Label Manufacturer” in order to offer Class II,
III or IV private label medical devices in Canada. These are devices manufactured
by a different company, but labeled as YI or one of their businesses.
6.16.2 A cross-referenced private label device license application must include a letter
signed by a senior official of the original manufacturer on the original
manufacturer’s letterhead in which the senior official:
6.16.2.1 Attests that the device is a “private label medical device”;
6.16.2.2 Provides permission to the private label manufacturer and to Health
Canada to cross-reference the original MDL application and the
supporting safety, effectiveness and quality systems information held
by the original manufacturer or by Health Canada; and

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 Document Number C1053 Rev. F

Effective Date: 04-AUG-2022 Page 4 of 4

Title: Canadian Device License Procedure

6.16.2.3 Agrees that the original manufacturer would provide, upon request
from Health Canada, any information respecting the safety,
effectiveness and quality of the private label medical device.
6.16.2.4 When an original manufacturer’s MDL is amended, the private label
MDL is automatically amended. However, a private label manufacturer
is required to amend their device license if they are making a change
in the device name, a change in the manufacturer’s name or if an
identifier of the device is being changed, added or deleted.
6.16.2.5 All other 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. These provisions include having systems in place to
handle complaints and to manage mandatory problem reporting and
recalls. The private label manufacturer must notify Health Canada of
any recalls of their licensed private label medical devices.
6.16.2.6 Private label manufacturers that do not hold ISO 13485quality
systems certificates under the Canadian Medical Devices Conformity
Assessment System (CMDCAS) are subject to inspection by the
Health Products and Food Branch Inspectorate.
6.17 Copies of license applications are to be retained in the regulatory files.
7.0 CHANGE HISTORY
Revision DCR # Effective Date Reason(s) for Change
Updated to reflect Young OS LLC operations at Algonquin, IL facility. Replaces
A N/A 25-JAN-2011
QP-4.22-007.
B 721 05-APR-2018 Rewrite to ensure MDSAP compliance for all national YI business units.
Changed document number from “P” to “C” to identify document as corporate-
C 819 28-Jan-2019
level.
Update to clarify the need for communication to appropriate regulatory
D 1011 16-FEB-2022
authorities for items noted in ISO 13485:2016, clause 7.2.3.
E 1032 Removed reference to 13488 in section 6.16.2.6 Per PREAT audit finding
Addition of new form F1C1053 to Reference Documents as well as Procedure to
F 1056 04-AUG-2022 ensure CMDR safety and effectiveness requirements are documented for
devices sold to Canada.

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This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
>>THE USER OF A DOCUMENT CONTROLLED BY A REVISION NUMBER IS RESPONSIBLE FOR CHECKING THE
CURRENT EFFECTIVE DATE AGAINST THE APPROPRIATE MASTER INDEX BEFORE USING THE DOCUMENT<<