Medical device establishment licence application form (FRM-0292)

Protected A When Completed

Medical device establishment licence application form (FRM-0292):

Application checklist

Note:

Your cover letter should identify all documents included with your application. If submitting a notification or amendment, clearly identify any

changes from previous applications. You may include this checklist with your application, which will help to speed up the processing of your request.

Do not modify this form.

Application type

Sections to be completed

Action

New licence application

(applying for your first MDEL or

applying for a new MDEL after a

cancellation)

Cover letter (recommended)

Application

checklist

Entire application (Sections 1 to 7)

Notification

(submit changes to name and address

of the establishment or the contact

information on your MDEL)

Cover letter (recommended),

include

MDEL number

Application checklist

Section 1

Section

Section 7

Modify

Amendment of an existing MDEL

(submit any changes to your existing

MDEL, for example, device class

listed)

Cover letter (recommended),

include

MDEL number

Application checklist

Section 1

Section 2

Section 3

Section 4

Section 5

Section 6

Section 7

Request to amendment T&Cs

Modify

Add Remove Modify

Modify

Reinstatement of an MDEL

(reinstate your licence after a

suspension by Health Canada)

Cover letter (recommended), include MDEL number

Application checklist

Entire application (Section 1-7)

Cancellation of an MDEL

(request to cancel your MDEL)

Cover letter (recommended), include MDEL number

Application checklist

Section 1

Appendix A

End of Checklist

2 | Medical device establishment licence application form (FRM-0292) Protected A when completed

Medical device establishment licence application form (FRM-0292)

All fields indicated by an asterisk (*) are mandatory.

Section 1: Application type

1. *Application type

New

Notification (see section 48 of the Medical Devices Regulations)

Amendment

Reinstatement

Cancellation (see Appendix A below)

2. Current MDEL number held by the establishment, if

applicable:

3. Current or previous company ID held by the

establishment, if applicable:

4a. Any previous MDEL number(s) held by the establishment, if applicable:

4b. Any other names under which you previously conducted a licensable activity. Include names associated with a merger,

if applicable. You do not need to include names associated with acquisitions.

Note: This does not apply for a change to current establishment name (Notification). For Notifications, complete Section 2.

*Name

Start (yyyy-mm-dd) End (yyyy-mm-dd)

End of Section 1

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Section 2: Applicant Information

5. *Establishment name (this is the Medical Device Establishment Licence holder):

6. Operating, trade, or partnership name, if different from establishment name above:

7. Small business mitigation

Option 1

I certify that I have received confirmation from Health Canada that the small business registration or

renewal for this company has been processed. I also certify that I hold valid small business status with

Health Canada at the time of submitting this application.

Option 2

I am not applying for the small business mitigation.

Note:

If option 1 is not selected, the full fee will be charged and you will not be considered for the small business

mitigation.

See section 1 of the Fees in Respect of Drugs and Medical Devices Order for the definition of a small business.

8. Fee exemption (if applicable):

Not applicable

I certify that I meet the definition of a publicly funded health care institution.

I certify that I am a branch or agency of the Government of Canada or of a province or territory

See section 3 of the Fees in Respect of Drugs and Medical Devices Order for more details.

Section 2.1 Establishment address (where the licensable activities are conducted, this cannot be a P.O. Box)

9. *Building name or number:

10. *Street:

11. *Suite:

12. *City:

13. *Province/state: 14. *Postal/

zip code:

15. *Country:

16. *Business is located in a personal home/dwelling:

Yes No

17. Business number (9-digit number):

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Section 2.2 Contact person for the establishment licence (Establishment representative)

18. *Title:

19. *Preferred language:

English French

20. *Surname:

21. *Given name(s):

22. *Email:

23. *Telephone:

24. Fax:

Section 2.3 Mailing address

25.  Same as Section 2.1 establishment address above

26. Establishment name, if different:

27. Building name (if applicable):

28. Street number:

29. Street name:

30. Suite:

31. City:

32. Province/state: 33. Postal/

zip code:

34. Country:

Section 2.4 Billing address

35. Same as Section 2.1 establishment address above

36. Same as Section 2.3 mailing address above

37. Establishment name, if different:

38. Building name (if applicable):

39. Street number:

40. Street name:

41. Suite:

42. City:

43.Province/state: 44. Postal/

zip code:

45. Country:

46. Billing contact person (if different) Title:

47. Preferred language:

English French

48. Surname:

49. Given name(s):

50. Email:

51. Telephone:

52. Fax:

End of Section 2

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Section 3: Activities

Important: Before filling out this section, you must carefully read the Guidance on Medical Device Establishment Licensing

(GUI-0016)

. GUI-0016 defines a distributor, importer and manufacturer.

Only an establishment located in Canada can be an Importer.

Only importation and distribution are licensable activities under an MDEL, including for Class I manufacturers.

53. *Activity

Distributor

Importer

(includes

distribution)

Manufacturer of Class I devices

(who imports/distributes their own devices)

54. *Class of device

Class I

Class II

n/a

Class III

n/a

Class IV

n/a

You may include a brief description of the type of business (structure and types of customers):

End of Section 3

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Section 4: Site Information

A site is any additional building that is used by the MDEL holder (establishment) where the procedures attested to in

section 6 (according to paragraphs 45(g) to (i) of the Medical Devices Regulations) are in place. A site cannot be located

at a P.O. box address and must be in the same country as the establishment indicated in section 2.1.

If the site listed is not the same legal entity, then it is the responsibility of the licence holder to ensure that site(s) listed in

section 4 of their MDEL application has the applicable procedures in place and that inspectors are able to verify

compliance without any impediment.

Important: The establishment address is considered a building where procedures attested to are in place, unless you

indicate otherwise. You must list any additional building address(es) where procedures attested to are in place. You may

use this section to indicate specific procedures at the establishment address and the additional building(s).

55.

Establishment name and address in section 2.1 above

Status

Active Inactive

56.

Establishment name:

57. Company ID number, if applicable:

58. Street number: 59. Street name: 60. Suite:

61. City: 62. Province/state: 63. Postal/

zip code:

64. Country:

65. *Documented procedure at this site (select all that apply) for:

Distribution records

Storage

Complaint handling

Delivery

Recall

Installation

Incident reporting

Corrective action

Serious risk of injury to human health

Handling

Servicing

Site

Status

Active Inactive

66. Establishment name: 67. Company ID number, if applicable:

68. Street number: 69. Street name: 70. Suite:

71. City: 72. Province/state: 73. Postal/

zip code:

74. Country:

75. Documented procedure at this site (select all that apply) for:

Distribution records

Storage

Complaint handling

Delivery

Recall

Installation

Incident reporting

Corrective action

Serious risk of injury to human health

Handling

Servicing

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Site

Status

Active Inactive

76. Establishment name: 77. Company ID number, if applicable:

78. Street number: 79. Street name: 80. Suite:

81. City: 82. Province/state: 83. Postal/

zip code:

84. Country:

85. Documented procedure at this site (select all that apply)

Distribution records

Storage

Complaint handling

Delivery

Recall

Installation

Incident reporting

Corrective action

Serious risk of i

njury to human health

Handling

Servicing

End of Section 4

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Section 5:

Manufacturer(s) of the devices that are being imported or distributed,and any Supplier(s)

8 | Medical device establishment licence application form (FRM-0292) Protected A when completed

Important:

The name of the manufacturer is on the label of each product. This section must not be left blank.

A supplier is any person, other than the manufacturer, who distributes (sells) a medical device to an MDEL holder for the

purpose of import or

sale in Canada. Please do not list yourself as the supplier.

86. *

Manufacturer

Supplier

Status

Active Inactive

87. *Name of the manufacturer or supplier:

88. *Company ID number:

89. *Street number:

90. *Street name:

91. Suite:

92. *City:

93.

*Province/state:

94. *Postal/

zip code:

95. *Country:

96. *Risk class:

Class I

Class II

Class III

Class IV

97.

Manufacturer

Supplier

Status

Active Inactive

98. Name of the manufacturer or supplier:

99. Company ID number:

100. Street number:

101. Street name:

102. Suite:

103. City:

104. Province/state: 105. Postal/

zip code:

106. Country:

107. Risk class:

Class I

Class II

Class III

Class IV

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108.

Manufacturer

Supplier

Status

Active Inactive

109. Name of the manufacturer or supplier:

110. Company ID number:

111. Street number:

112. Street name:

113. Suite:

114. City:

115. Province/state: 116. Postal/

zip code:

117. Country:

118. Risk class:

Class I

Class II

Class III

Class IV

End of Section 5

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Section 6: Attestations (read each section below carefully and check all relevant attestations)

Important:

Health Canada will inspect your establishment to verify your attestation in section 6 and your establishment’s compliance

with the Medical Devices Regulations.

Pursuant to Part I, Section 45, paragraph (g), (h), (h.1) and (i) of the Medical Devices Regulations, a senior official of the

establishment applying for an establishment licence shall submit an application to the Minister that contains attestations

based on the activities conducted by this establishment, as applicable.

Note: As per Section 59 of the Medical Devices Regulations, there are incident reporting requirements for

manufacturers. You may maintain other relevant procedures as applicable and present them during an inspection, even

if attestation under section 6 is not required.

119. *Section 45(g): Required of all establishments

The establishment has documented procedures in place in respect of:

distribution records, complaint handling, recalls

120.

Section 45(h): Required if you are an importer of Class I devices

The establishment has documented procedures in place in respect of the making of reports under subsection 59(1)

and (1.1)

Section 45(h.1): Required if you are an importer of Class II, III or IV devices

The establishment has documented procedures in place in respect of the making of reports under subsection 59(1)

and the provision of information under section 61.2

Not an importer

121. *Section 45(i): Required if you are an importer or distributor of Class II, III or IV devices

The establishment has documented procedures in place for:

handling, storage and delivery

installation

corrective action

servicing

Not an importer or distributor of Class II, III or IV devices

End of Section 6

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Section 7: Signature

This section must be read carefully, signed and dated by the senior official of the establishment acknowledging that all

the information in this application is accurate and that all required regulatory procedures are in place. This section should

only be signed by the senior official of the company.

Important: The name of the senior official associated with an MDEL is published in Health Canada’s medical devices

establishment licence listing

along with other posted information about establishments.

Note: Health Canada recommends that manufacturers and importers develop internal written procedures for reporting

medical device shortages and discontinuations. For more information, refer to the

Guide to reporting medical device

shortages and discontinuations.

I, the undersigned, acknowledge that:

It is a serious offence to knowingly make false attestations on this application and it could lead to establishment

licence refusal or suspension (subsection 47(1) and paragraph 49(1)(b) of the Medical Devices Regulations,

respectively).

As a senior official of the establishment named in this application, I have direct knowledge of the documented

procedures in place, as confirmed by the attestations in section 6 of this document.

Selling or importing medical devices without a valid MDEL is contrary to subsection 44(1) of the Medical Devices

Regulations

and is subject to compliance and enforcement actions.

Selling or importing medical devices contrary to any existing Terms and conditions (under section 48.1 of the

Medical Devices Regulations) is subject to compliance and enforcement actions.

For Class II, III, or IV devices, this establishment shall only sell licensed devices, as per section 26 of the Medical

Devices Regulations

(unless authorized under the Medical Devices Regulations).

6. Manufacturers of Class I to IV medical devices and importers of Class I medical devices have an obligation to

report medical device shortages and discontinuations that will lead to a shortage to Health Canada. This is in

accordance with section 62.23 of the Medical Devices Regulations.

122. *Name:

123. *Title:

124. *Signature:

125. *Date (yyyy-mm-dd):

End of Section 7

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Appendix A – Cancellation of Medical Device Establishment Licence

Important:

 Only the contact person or senior official for the MDEL may submit a cancellation request to Health Canada.

 Health Canada may inspect an establishment that had its MDEL cancelled, to verify that all licensable activities

have ceased on the date indicated below.

126. *Company name:

127. *Medical Device Establishment Licence (MDEL)

number:

128. *Street number:

129. *Street name:

130. Suite:

131. *City:

132. *Province/state: 133. *Postal/

zip code:

134. *Country:

135.*

I (print name)

____________________________________________________________________________________

(title)

________________________________

_______________________

as an authorized

representative of the

above company, confirm that:

“I have ceased licensable activities for MDEL number

__________

on (yyyy-mm-dd)

_________________

, and I do not

plan to conduct licensable activities in Canada. I would like to request that my MDEL be cancelled.”

136. *Name:

137. *Title:

138. *Signature:

139. *Date (yyyy-mm-dd):

End of Appendix A

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Privacy notice: The personal information you provide to Health Canada is governed in accordance with the Privacy Act.

We only collect the information we need to administer Medical Device Establishment Licencing regime, authorized under

the Medical Devices Regulations.

Purpose of collection: We require your personal information to process your request for a Medical Device Establishment

Licence as per sections 44 to 51.1 of the Medical Devices Regulations to the Food and Drugs Act.

Other uses or disclosures: In limited and specific situations, your personal information may be disclosed without your

consent in accordance with subsection 8(2) of the Privacy Act. The name of the senior official associated with a MDEL is

published in Health Canada’s medical devices establishment licence listing along with other posted information about

establishments.

Refusal to provide the information: Failure to provide the requested information may prevent the processing your

request for a Medical Device Establishment Licence.

For more information: This personal information collection is described in Info Source, available online at

www.canada.ca/en/health-canada/corporate/about-health-canada/activitiesresponsibilities/access-information-

privacy/info-source-federal-government-employeeinformation.html. Refer to the class of records HC HP 040.

Your rights under the Privacy Act: In addition to protecting your personal information, the Privacy Act gives you the

right to request access to and correction of your personal information. For more information about these rights, or about

our privacy practices, please contact mdel.questions.leim@hc-sc.gc.ca.

You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information

has been handled improperly.

Pub.: 190321

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