NOTICE

Guidance for Industry - Medical Device Licence Renewal

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August 23, 2005

Our file number: 05-111977-811

Please find attached the revised Guidance for Industry - Medical Device Licence Renewal. This guidance document supersedes the September 15, 2004 version of the same document.

The Guidance for Industry - Medical Device Licence Renewal outlines the process used to renew medical device licences by the Medical Devices Bureau. It provides medical device manufacturers and regulatory correspondents with the steps involved in renewing a medical device licence.

The document has been revised to reflect a streamlining of the renewal process. Beginning with the 2005 renewal period, all new licences issued between July 27 and November 1 will be automatically renewed. Manufacturers holding/obtaining new licences issued between July 27 and November 1 will be provided with a fee reduction form and a renewal advisory when their medical device licence is mailed to them.

For more information on Medical Device Licence Renewal, please contact:

Licence Renewal
Licensing Services Division
Medical Devices Bureau
Room1605, Main Statistics Canada Building
Tunney's Pasture
Address Locator: 0301H1
Ottawa, Ontario K1A 0K9

Phone: (613) 946-6555
Fax: (613) 946-6563
Email: License_Renewal@hc-sc.gc.ca

Published by authority of the
Minister of Health

Date Adopted 2004/09/15

Revised Date 2005/08/17

Effective Date 2005/08/17

Health Products and Food Branch

© Minister of Public Works and Government Services Canada 2005

Available in Canada through
Health Canada - Publications
Brooke Claxton Building, A.L. #0913A
Tunney's Pasture
Ottawa, Ontario
K1A 0K9

Tel: (613) 954-5995
Fax: (613) 941-5366

Également disponible en français sous le titre: Renouvellement de l'homologation d'un matériel médical

FOREWORD

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations. They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidances.

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TABLE OF CONTENTS

1.0 PURPOSE

2.0 BACKGROUND

2.1 Definitions

3.0 SCOPE

4.0 PROCEDURES

4.1 Licence Renewal Forms
4.2 Invoicing
4.3 Failure to Renew
4.4 How to Complete Renewal Forms
4.5 Fee Reduction and Certification Form

Appendix 1 Sample Medical Device Licence Renewal Form

Appendix 2 Sample Fee Reduction and Certification Form

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1.0 PURPOSE

This guidance document outlines the process used to renew medical device licences by Health Canada.

This guidance document will provide medical device manufacturers and regulatory correspondents with the steps involved in renewing a medical device licence.

The renewal process has two purposes. The first is to confirm whether the medical device will continue to be sold in Canada and the medical device licence will remain active. The second is to collect information concerning fees to be paid and fee reductions that should be applied prior to invoicing.

2.0 BACKGROUND

The promulgation of the Medical Devices Regulations (MDR) in 1998 set forth legislation prohibiting the sale in Canada of Class II, III, and IV devices without a medical device licence. Section 43 of the MDR requires every manufacturer of a licensed medical device to confirm that the information held by Health Canada is accurate, or that amendments to correct the information will be made.

Medical device licences are granted bearing an Issued Date. There is no expiry date. However, Section 43 of the MDR requires that manufacturers holding medical device licences (or the authorized regulatory correspondent) confirm annually, before November 1, their intention to renew their medical device licence(s) for the following year. Beginning with the 2005 renewal period, all new licences issued between July 27 and November 1 will be automatically renewed. Manufacturers holding/obtaining new licences issued between July 27 and November 1 will be provided with a fee reduction form and a renewal advisory when their medical device licence is mailed to them.

Annual renewal reports are issued to each "manufacturer" (as defined in the MDR) holding medical device licences and, in the absence of a regulatory correspondent, will be forwarded to the "manufacturer". Where a regulatory correspondent has been identified on a device licence application form, the report will be sent to their address. Failure to comply with Section 43 of the MDR will result in cancellation of existing medical device licences by the Therapeutic Products Directorate (TPD) (Section 43(2)). Cancellation of a medical device licence would require the filing, and subsequent review, of a new medical device licence application. The payment of applicable screening and evaluation fees would be required again.

Section 12(1) of the Fees in Respect of Medical Devices Regulations sets out the following table of fee based on Annual Gross Revenue

Section 12(2) of the Fees in Respect of Medical Devices Regulations states, "The fee set out in column 2 of Item 1 of the table to subsection (1) must be accompanied by a statement, certified as true and correct by the person responsible for the manufacturer's financial affairs, declaring that the annual gross revenue for the applicable medical device was less than $20,000."

Section 12(3) of the Fees in Respect of Medical Devices Regulations provides for a reduction in the fees, "Despite subsection (1) and subject to subsection (4), if the total amount of the fees to be paid under subsection (1) by a manufacturer for all of the manufacturer's licensed medical devices is greater than an amount equal to 1.5 per cent of the total annual gross revenue from all of the manufacturer's licensed medical devices, the total amount of the fee under that subsection for all of those medical devices shall be reduced to an amount equal to that 1.5 per cent".

Further, Section 12(4) of the Fees in Respect of Medical Devices Regulations includes that, "The reduced fees set out in subsection (3) must be accompanied by a statement, certified as true and correct by the person responsible for the manufacturer's financial affairs, that sets out the total annual gross revenue of the manufacturer from all of its licensed medical devices".

The Fees in Respect of Medical Devices Regulations contain a provision to permit the Department to verify the Actual Gross Revenue and Annual Gross Revenue: Section 13(1) states, "If the Minister determines, on the basis of any information available to the Minister, that the statements provided in accordance with subsection 9(2) or 12(2) or (4) or the sales records provided in accordance with subsection 9(3) are not adequate to determine the manufacturer's actual gross revenue or annual gross revenue, the Minister may require the manufacturer to submit sales records that ave been audited by a qualified independent auditor and those records shall be used for the purpose of determining the fee payable".

2.1 Definitions

1. Manufacturer (as defined in the MDR) - is a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.
   
   
2. Regulatory Correspondent - a person authorized by the manufacturer to act on their behalf.
   
   
3. Licence Renewal - refers to all "obligation to inform activities" described in Section 43 of the MDR.
   
   
4. Medical Device Licence - refers to medical device licences issued by the Medical Devices Bureau on behalf of the Minister for Class II, III and IV medical devices sold in Canada.
   
   
5. Establishment Licence - an establishment licence is issued by the Health Products and Food Branch Inspectorate (HPFBI) on behalf of the Minister to persons who import, distribute, or in the case of Class I devices, manufacture medical devices in Canada.

3.0 SCOPE

This guidance document covers the application of Section 43 of the MDR and Section 12 of the related Fees in Respect of Medical Devices Regulations. It includes Medical Device Licence Renewal, administered by the Medical Devices Bureau. This document does not include Establishment Licensing Renewal which is administered by the HPFB Inspectorate.

4.0 PROCEDURES

In August of each year, the Medical Devices Bureau mails a renewal package to manufacturers or regulatory correspondents assigned by the manufacturer holding the medical device licences.

This package includes the following:

• The Annual Medical Device Licence Renewal form (yellow)
• A guidance document which provides instructions for the completion and return of the Renewal Report
• A Fee Reduction and Certification Guidance and Form
• May contain additional information concerning new regulatory issues

The renewal forms are generated containing specific medical device licence numbers and names for each manufacturer. Generic forms cannot be used. Regulatory correspondents can obtain a copy of the renewal form upon request of the licence renewal unit of the Licensing Services Division of the Medical Devices Bureau.

A description of the medical device licences renewed and the fees assessed accompanies the invoice. The invoices are mailed in late January or early February. The invoice documentation confirms renewal of the medical device licence(s). No new medical device licences are issued as a result of the renewal process.

4.1 Licence Renewal Forms

The renewal form is intended to assist in complying with Section 43 of the MDR. It contains an attestation signed by a senior official of the company. The official attests that the information supplied on the renewal form is correct or subsequent amendments will be made to make the information correct. The information on the form includes the manufacturer's name and address, the regulatory correspondent's name and address, and a licence listing for the manufacturer. A column beside the licence listing contains a block which is checked if the medical device licence is to be discontinued.

The name of the contact person for the regulatory correspondent is identified from previous renewal forms or directly from the application form if the licence is newly issued. The name of the contact person can be changed on the renewal form.

All other changes or additions to the medical device licence must be made by the established licence amendment process. Please review the information on the medical device licences to ensure information is up to date and accurate. For detailed information on device identifiers assigned to a licence and for a complete licence listing, refer to the following website: www.mdall.ca

If any of the information has been changed, the appropriate amendment forms must be submitted. These forms are available on the website:

• Medical Devices Licence Amendment Fax-Back Form - Guidance for Non-Significant Additions/Deletions (non-significant changes to catalogue numbers)
• Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to Manufacturer's Name and/or Address of Existing Device Licences
• Licence Amendment Fax-Back Form - Guidance for Changes to the Name of a Device for Existing Device Licences
• Application for a Medical Device Licence Amendment

Amendment to medical device licences should be made as changes occur. This is particularly important for the names and addresses of the regulatory correspondent. If the renewal forms do not reach the correct contact due to a change in address, the possibility exists that the medical device licence(s) may be cancelled inadvertently.

Medical device licences listed on the renewal form may be renewed or discontinued.

As mentioned above, in August of each year, the Medical Devices Bureau mails a renewal form to permit manufacturers to comply with this annual notification. Licences issued after July 27 are not included in this package. Beginning with the 2005 renewal period, all new licences issued between July 27 and November 1 will be automatically renewed. This action will reduce the administrative burden to manufacturers and to the Bureau, recognizing the limited benefit of renewing licences that have just been issued.

Manufacturers are still required to pay a renewal fee for new licences issued between July 27 and November 1. Manufacturers holding/obtaining new licences issued between July 27 and November 1 will be provided with a fee reduction form and a renewal advisory when their medical device licence is mailed to them. Unless the completed fee reduction form is duly returned to the Medical Devices Bureau, a $100 fee for the right to sell a licensed class II, III, or IV medical device in Canada will be included in the invoice that will be mailed in early January (see 4.2 below).

4.2 Invoicing

No payment is required with the return of the renewal form. Renewal applications and any fee reduction applications are processed, and an invoice is generated. The invoice and a description of the medical device licences billed are mailed in January. The medical device licence description documents the medical device licences that have been renewed. No new medical device licences are issued.

4.3 Failure to Renew

Failure to comply with Section 43 of the MDR will result in cancellation of existing medical device licences. The invoicing process will bill only valid renewed medical device licences. Medical device licences not renewed have either been discontinued by the manufacturer, or have been cancelled by the Medical Devices Bureau for failure to renew by the November 1 deadline.

If a medical device licence has been cancelled, the product may no longer be offered for sale in Canada. In order to bring the medical device back into compliance, the manufacturer or regulatory correspondent would be required to submit a new medical device licence application, as well as all applicable fees.

4.4 How to Complete Renewal Forms

The following instructions are offered as a guide to completing the medical device licence renewal forms. A copy of a sample form (for illustration purposes only) may be found at the end of this document.

The Renewal Form (yellow) contains a cover page with the name and address of the regulatory correspondent and contact person, followed by pages containing the name of the manufacturer and abbreviated medical device licence listings. Indicate medical device licences that should be discontinued by placing an [X] beside the medical device licence number in the discontinue column. Make corrections to the Licence Renewal contact person information in the space provided to the right of the contact data listing on the cover page.

• Review the attached Fee Reduction and Certification Guidance and Form document included in this package to determine if you qualify for a fee reduction.
  
  
• Sign the attestation section on the renewal form. The signature of a senior official of the "manufacturer" who holds the medical device licences, or their regulatory correspondent is required.
  
  
• Mail the Renewal form and, if applicable, the Fee Reduction and Certification forms to the address on the following page.

If the relationship between a regulatory correspondent and a manufacturer is no longer in effect, the manufacturer should notify the Bureau by letter of the new corresponding company. This can be the manufacturer or another company. Failing this, a letter can be sent from the regulatory correspondent advising the Bureau that they no longer represent the manufacturer and do not wish to complete the renewal forms. The renewal form should only be used to discontinue medical device licences on the expressed wish of the manufacturer.

4.5 Fee Reduction and Certification Form

A Fee Reduction and Certification form is included with the Medical Device Licence Renewal package. All fees are in Canadian dollars. All sales apply to sales in Canada that have occurred during the manufacturer's fiscal year ending before November 1. The fee for each medical device licence is $100.00 for sales of licensed product over $20,000, and each medical device licence is $50.00 for sales less than $20, 000. A fee reduction can be granted if the medical device licence fees exceed 1.5 % of total gross sales.

• A Fee Reduction form is not required to be completed to renew the licence. If no Fee Reduction form is received a full fee of $100.00 is assessed.

Appendix 1 Sample Medical Device Licence Renewal Form

The following is an example of a Medical Device Licence Renewal Form. It is included for illustration purposes only, and it is not to be submitted to the Medical Devices Bureau. A genuine renewal form contains data for a particular manufacturer and lists the medical device licences issued to that manufacturer.

Renewal forms are mailed to the regulatory correspondent assigned by the manufacturer. The forms are mailed in early August. If a regulatory correspondent has not received a renewal form by September 1, they are to contact Licence Renewal at the address listed above. A form which is populated with renewal data and lists the medical device licences to be renewed will be sent to the regulatory correspondent by email in a pdf format, or a copy can be faxed.

Appendix 2 Sample Fee Reduction and Certification Form
Annual Medical Device Licence Renewal

Complete only if you qualify for a fee reduction. Only one manufacturer can be included on each form. Do not submit payment with this form. The returned renewal form and any adequately supported fee reduction request will be assessed and an invoice based on this assessment will be mailed to you. Fees payable are $100.00 Canadian per licence unless you qualify for a fee reduction. To qualify, you must meet at least one of the two criteria listed below. Choose one, and fill in fields only in the column selected.

Certification
Article 12(2) and (4)
Manufacturer's completed fiscal year ending before November 1st (dd/mm/yy):_________________________________