Medical Device Establishment Licence Application: Form and Instructions (FRM-0292)

Contact Information

Notice

Our Mandate:
To manage and deliver a national compliance and enforcement program for blood and donor semen; cells, tissues and organs; drugs (human and veterinary); medical devices and natural health products, collaborating with and across, all regions.

Supersedes: April 1^st, 2011

Date issued: December 12, 2012

Date of implementation: December 12, 2012

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies.

The following describes the process for completing the Medical Device Establishment Licence (MDEL) application form.

Step 1: Read the Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016).

GUI-0016 can be found on the Health Canada website

Step 2: Determine if your product is a medical device. If yes, what class is it?

It is the responsibility of the applicant to determine that the device(s) indicated on the application have been classified as a medical device and to obtain the correct classification of the medical device. Fees for the review of the application are not refunded should it be later determined that the product(s) are not medical devices or of a different risk class.

1. Read the Draft Guidance for the Risk-based Classification System can be found on the Health Canada website.
2. If your product is a licenced class II, III or IV medical device, it will be listed found on MDALL.
3. If the class II, III or IV medical device cannot be found on MDALL, it is not licenced and cannot be imported or sold in Canada.
4. If further classification assistance is required, contact the Medical Device Bureau by email at device_licensing@hc-sc.gc.ca or by fax at (613) 957-6345.

Step 3: Determine your activities

Also read the Frequently Asked questions available on the Health Canada website and the common scenarios below.

Common scenarios & activities

Applicants in Canada

• I distribute medical devices from a supplier that is outside of Canada; Importer only
• I distribute medical devices from a supplier in Canada; Distributor only
• I distribute some medical devices from a supplier outside of Canada and some from a supplier in Canada; Importer and distributor (both)

Applicants outside of Canada

• I sell and/or send (distribute) medical devices to Canada and my name is not on the product label; Distribute only
• I sell and/or send (distribute) medical devices to Canada and my name is on the product label; Manufacturer (see scenarios below)

Manufacturers (in & outside of Canada)

• I only distribute class I medical devices that has my name on the label as the manufacturer; Manufacturer only
• I sell and/or distribute medical devices to Canada. I am the manufacturer listed on the label of some of the class I medical devices I sell but not all of them; Manufacturer & distributor (both)
• I only distribute class II, III and/or IV medical devices that has my name on the label as the manufacturer; * Medical Device Licence (MDL) is required and not a MDEL. Contact Medical Device Bureau
• I only distribute class I medical devices that has my name on the label as the manufacturer and my client (importer) has an MDEL; Exempted. No need for an MDEL or MDL

Step 4: Complete the Application Form

Section 1
Company Name & Contact Information

This page is the contact information and the reason for the application (i.e. new, amendment, annual review, other (including cancellation), etc.).

• Applicant Name*: is the legal name of the person or company
• Trade Name is any other commercial company names(s) under the ownership of the Applicant Name
• Business Name Registration(s) is the Federal or Provincial Business Name Registration Numbers(s). If provincial, please specify which provinces.
• Contact Name* is the person that will be contacted by Health Canada about the licensing or licence
• Phone number and extension*
• Fax number*
• Email* is the primary form of correspondence for licensing and sharing information with stakeholders
• Language of preference

*This information must be updated and correct at all times. If at any time this information changes notify the Establishment Licensing, Billing and Invoicing Unit (ELBIU) within 15 days.

Section 2
Licence, Mailing and Billing Addresses

This page details the principle physical address where licensable activities occur. This is the address that will appear on the licence. This page also includes the mailing and billing address, if different.

• Company Name*
• Full Company Address* (including postal code)

*This information must be updated and accurate at all times. If at any time this information changes notify the Establishment Licensing, Billing and Invoicing Unit (ELBIU), within 15 days of the changes.

Section 3
Classes and Activities Table

Put an X for each activity and class that applies. Use the scenarios in Step 2 and 3 to determine the activities.

Section 4
Site Address

Site: any additional building, of the same legal entity as the applicant (same corporation), where the activities listed on the Medical Device Establishment Licence application are conducted, and where the attested to procedures are in place.

Please list all sites in the space provided and use additional pages if required.

Section 5
Manufacturer Information

This part of the form sees the highest amount of errors.
Errors lead to longer review times.
Please read the information below carefully.

Who is the manufacturer?

The name of the manufacturer is on the label of the product.

You are the Class I Manufacturer?

• Include your name and address in this section.

You are the distributor and/or importer of Class I medical devices?

• Provide the names and full addresses of all the manufacturers of the class I medical devices you will be importing or distributing as per the activities indicated on part 3.

You are an importer and/or distributor of class II, III, IV – Must do a MDALL Search

1. Visit MDALL - The MDALL (Medical Device Active Licences database) website allows you to search all licensed manufacturers of class II, III and IV medical device licences.
2. Search by device # (found on the label), product or company name as well as company ID.
3. For each manufacturer of class II, III and IV medical devices:
   1. Confirm that the manufacturer is licensed for all the risk classes of devices.
   2. Enter the address, as listed in MDALL.
   3. Enter the corresponding 6-digit company ID number, as listed in MDALL.

If you are adding manufacturers, you may include additional page 7 of the application form as required.

Section 6
Attestations

A Senior Official of the establishment applying for a licence must complete the attestations based on the activities conducted by this establishment.

• Read each statement and annotate place an X, initial or for each applicable attestation statement. An MDEL will not be issued without completed attestations.
• All attested to procedures must be in place.
• All establishments must have documented procedures pursuant to Section 45(g).
• All establishments that are Importers must have documented procedures pursuant to Section 45(h).

Section 7
Signature

1. This page is to be read carefully, signed and dated by a senior official of the establishment.
2. This page is to be read carefully, signed and dated by a senior official of the establishment.

Class I Annexe

Please provide a list of Class I medical device manufactured, distributed and /or imported by your company on the Class I device annexe attached to the application form.

• For amendments and annual review applications, only provide changes to your product list in this section by indicating if it is a addition, removal or edit to an existing product.

Need help?

Establishment Licensing Questions
Email: MDEL_questions_LEPIM@hc-sc.gc.ca

Step 5: Fees

1. Fees are applicable for new and annual review applications. At this time, applications to amendment of the licence are not subject to fees.
2. Determine if you are eligible for fee deferral
3. Determine if you are eligible for fee remission. If yes, include a certified statement of revenue with this form when submitting your application to Health Canada.
4. Submit fees at the time of application.

Fee Deferral

For applicants who have not completed their first full calendar year of conducting activities under an establishment licence, the payment of the applicable MDEL fee is deferred until the end of the first full calendar year. For example, if an applicant submits an application for a MDEL on any day in 2012, the payment of the fee is deferred until the final business day of December 2013.

Fee remission

Applicants can also apply for fee remission if the fee payable is greater than 1% of the applicant’s actual gross revenue generated from activities conducted under a MDEL during the previous calendar year

Need help?

Invoicing (Fees and Invoices) Questions
Email: ELIU_UFLE@hc-sc.gc.ca

Step 6: Submit your application, payment and fee documents

How?

• Send only one application. Chose email, fax or mail.
• Do not send duplicate applications.
• Always keep the records demonstrating that the application and information has been received by Health Canada before April 01, 2013. Save the email sent or cc. yourself; Keep the facsimile transaction confirmation with number of pages and our fax number; Keep all relevant shipping or mailing records.
• Always keep copies of the application and all information sent.
• To submit hard copy information such as fees related to an application previously sent by email or fax, simply print the email or fax cover page that was sent and enclose with the hard copy documents.

Where?

Email: ELapplicationLE@hc-sc.gc.ca (preferred)
Fax: (613) 957-6711 or (613) 957-4147

If hard-copy documents, such as cheques, must be submitted, you may submit them to the following address. If submitting hard-copy documents, please include as a cover letter a copy of the e-mail sent for reference.

Establishment Licensing, Billing and Invoicing Unit
Health Products and Food Branch Inspectorate
250 Lanark Avenue
Graham Spry Building – 2^nd Floor
Address Locator 2002D
Ottawa, Ontario
K1A 0K9
Fax: 613-957-4147

Medical Device Establishment Licence Application Form

Submit the application form to:
ELapplicationLE@hc-sc.gc.ca

If hard-copy documents, such as cheques, must be submitted, you may submit them to the following address. If submitting hard-copy documents, please include a copy of the e-mail with the mailed information. This will serve as a reference.

Establishment Licensing, Billing and Invoicing Unit
Health Products and Food Branch Inspectorate
250 Lanark Avenue
Graham Spry Building – 2nd Floor
Address Locator 2002C
Ottawa, Ontario  K1A 0K9
Fax: 613-957-4147

Please retain a copy of the completed application in your file.

Reason for Application :
Annuel Review :
Amendment :
Reinstatement :
Other :

Setion 1 – Applicant Information

Applicant Name :
Trade Name(s) :
Licence Number:
Establishment Licence Contact Name:
Phone:        Extension:
Fax :
Email:
Language : English or French

Section 2 – Addresses

Establishment Address
Company Name:
Street:
Suite:
Post Office Box:
City:
Province/State:
Postal Code/ Zip Code:

Mailing Address (same as licence address)
Company Name:
Street:
Suite:
Post Office Box:
City:
Province/State:
Postal Code/ Zip Code:

Billing (same as licence address) / (same as mailing address)
Company Name:
Street:
Suite:
Post Office Box:
City:
Province/State:
Postal Code/ Zip Code:

Section 3 - Activities

Read the instructions carefully and select those that apply

Distributor

Class I - Class II - Class III - Class IV
Manufacturersof Class I devices who distribute their own devices

Importer

Class I - Class II - Class III - Class IV
Manufacturersof Class I devices who distribute their own devices

Section 4 – Sites (buildings)

Please print this page off as many times as required

Site Address List

Company ID :
Company name:
Street:
Suite:
Post Office Box:
City:
Province/State:
Postal Code/ Zip Code:

Site Status:
Active or Inactive

Section 5 - Manufacturers

• The manufacturer is who is listed on the label.
• For all class II, III and IV medical device, verify that the manufacturer holds a valid medical device licence by searching MDALL
• To add manufacturers, please print as many manufacturer pages as required.

Manufacturers Address Form

Company ID #:
Company Name:
Street:
Suite:
Post Office Box:
City:
Province/State: Country:
Postal Code/Zip Code:
Manufacturer Status:
Active or Inactive

Risk Class:
Class I:
Class II:
Class III:
Class IV:

Section 6 –Attestations

Pursuant to Part I, Section 45, paragraph (g), (h) and (i) of theMedical Devices Regulations (MDR), a senior officer of establishment applying for an establishment licence shall submit an application to the Minister that contains attestations based on the activities conducted by this establishment. Please check all relevant attestations listed below. Conformément à la partie I, article 45, paragraphe g), h) et i) duRèglement sur les instruments médicaux (RIM), un dirigeant de l'établissement qui fait demande de licence d'établissement, doit présenter au Ministre une demande contenant les attestations nécessaires en fonction des activités réalisées par l'établissement et tous les sites énumérés. Veuillez cocher les attestations pertinentes indiquées ci-dessous.

Section 45(g) Required of all establishments

The establishment has documented procedures in place in respect of

• distribution records, complaint handling , recalls

Section 45(h) Required if the establishment is an importer

The establishment has documented procedures in place in respect of mandatory problem reporting:

• Not applicable. Not an importer

Section 45(i) Required if the establishment is an importer or distributor of Class II, III or IV devices (where applicable)

The establishment has documented procedures in place for:

• handling, storage and delivery
• installation
• corrective action
• servicing
• Not applicable. Not an importer or distributor of Class II, III or IV devices

Section 7 – Signature

I, the undersigned acknowledge that:

1. as a senior official of the establishment named in this application, that I have direct knowledge of the procedures in place, as confirmed by the annotation above. / En tant que dirigeant de l'établissement nommé dans la présente demande, j'atteste connaître de première main les procédures en place identifiées par les annotations ci-haut .
2. selling or importing medical devices without a valid establishment licence is in contravention of subsection 44.(1) of the Medical Devices Regulations and subject to compliance and enforcement actions/ Je reconnais que la vente ou l’importation des instruments médicaux sans licence d’établissement valide contrevient au paragraphe 44(1) du Règlement sur les instruments médicaux et est sujet aux mesures de conformité et d’application de la loi..
3. for Class II, III, IV devices, this establishment shall only sell licenced devices, as per section 26 of theMedical Devices Regulations, unless authorized elsewhere in theMedical Devices Regulations.

I acknowledge that it is a serious offence to knowingly make false attestations on this application.

Signature:
Date:
Name:
Title:

Only for applicants who have not completed their first calendar year./Uniquement pour les demandeurs qui n’ont pas terminé leur première année civile :

“I certify that I have not completed my first calendar year of conducting activities under an establishment licence”.

Signature:
Date:
Name:
Title:

Annex I: Class I Medical Devices

Medical Device Name
Type of Medical Device
Description