DRAFT GUIDANCE DOCUMENT

How to Complete the Application for a New Medical Device Licence

Published by authority of the
Minister of Health

Health Products and Food Branch

© Minister of Public Works and Government Services Canada 2006

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 : Comment remplir une nouvelle demande d'homologation pour un instrument médical

FOREWORD

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

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 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 document, 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 guidance documents.

TABLE OF CONTENTS

1. PURPOSE

2. BACKGROUND

3. DEFINITION

4. WHO NEEDS TO APPLY FOR A MEDICAL DEVICE LICENCE

5. HOW TO APPLY FOR A MEDICAL DEVICE LICENCE

6. WHEN IS A NEW MEDICAL DEVICE LICENCE REQUIRED

7. THE MEDICAL DEVICE LICENCE APPLICATION FORMS
Device Classification 3
Class II Applications 4
Class III and IV Applications

1. PURPOSE

This document describes how to complete an application for a new medical device licence for Class II, III and IV medical devices, including payment of applicable licence fees.

2. BACKGROUND

The Medical Devices Regulations (MDR) have been established under the authority of the Food and Drugs Act and apply to all medical devices imported and sold in Canada. The Therapeutic Products Directorate (TPD) has the regulatory responsibility for medical devices.

The MDR set out the requirements governing the sale, importation, and advertisement of medical devices in Canada. The level of regulatory scrutiny to be applied in these areas is based on risk management principles that uses a rule-based system to classify medical devices into four classes, with Class I representing the lowest risk and Class IV the highest.

For the purpose of the MDR, the term "medical device" means a device within the meaning of the Food and Drugs Act, but does not include any device that is intended for use in relation to animals.

With the intent to ensure the safety and effectiveness of devices sold in Canada, Part 1, section 26 of the MDR prohibits the importation or sale of a Class II, III or IV medical device unless the manufacturer holds a licence for that device.

3. DEFINITIONS

DEVICE ID refers to the device identification number assigned by Health Canada.

IDENTIFIER means a unique series of letters or numbers or any combination of these or a bar code that is assigned to a medical device by the manufacturer and that identifies it and distinguishes it from similar devices. Examples of an identifier for a device are a catalogue, model or part number.

LICENCE APPLICATION TYPE means the device can be submitted either as a single device, a system, a test kit, a device group, a device family or a device group family. The term "test kit" applies only to in vitro diagnostic devices. For more information on licence application types, refer to the Guidance for the Interpretation of Sections 28 to 31: Licence Application Type, which is available on the website.

MANUFACTURER means a person who sells the 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, labelling, 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. "Person" includes a partnership, firm or association.

4. WHO NEEDS TO APPLY FOR A MEDICAL DEVICE LICENCE

Medical devices imported or sold in Canada, with the exception of Class I medical devices, are required to be licensed prior to being imported or sold in Canada. One device licence will be issued to the manufacturer for each licence application submitted, if it is determined, on the basis of the information submitted, that it meets the safety and effectiveness requirements of the MDR.

5. HOW TO APPLY FOR A MEDICAL DEVICE LICENCE

To apply for a new medical device licence, ensure that:

1. The device licence application form is complete. The manufacturer may choose to have a Regulatory Correspondent complete and submit the application on their behalf.
   
   
   
2. The manufacturer signs the application form, certifying that all the information in the application is accurate and complete. A faxed copy of the manufacturer's signature is acceptable.
   
   
3. The applicable licence fee for a Class II, III or IV medical device is attached and submitted with the application.
   
   
4. The quality management system certificate is attached and submitted with the application.
   
   
5. The Licence Application Disclosure Request is attached and submitted with the application.
   
   
6. The manufacturer, or their regulatory correspondent, submits the application and any supporting documentation to:
   
   
   Device Licensing Services Division
   Medical Devices Bureau
   Therapeutic Products Directorate
   Room 1605, Main Building
   150 Tunney's Pasture Driveway
   Tunney's Pasture
   Address Locator 0301H1
   Ottawa, Ontario
   K1A 0K9
   Canada

6. WHEN IS A NEW MEDICAL DEVICE LICENCE REQUIRED

Under the Medical Devices Regulations (MDR), a device licence is a pre-market requirement for the following:

1. any new device not previously imported or sold in Canada as of July 1, 1998;
   
   
2. a licensed device which is being modified from the original licence application type, as defined in the Guidance for the Interpretation of Sections 28 to 31: Licence Application Type;
   
   
3. a device previously authorized for sale for investigational testing, or under the special access provisions of the MDR, and is now to be offered for general sale.

7. THE MEDICAL DEVICE LICENCE APPLICATION FORMS

Device Classification

The classification of your medical device is dependent upon its intended use. If a product is a Class I device, a medical device licence is not required. The rules to classify medical devices are outlined in Schedule 1 (Parts 1 and 2) of the MDR. Part 1 of Schedule 1 addresses medical devices other than in vitro diagnostics and Part 2 addresses in vitro diagnostic devices. Refer to the document Guidance for the Risk-based Classification System, or Guidance for the Risk-based Classification System of In Vitro Diagnostic Devices, as appropriate, for further guidance on the classification of medical devices. Once you have ascertained the class of the your device, use the appropriate application form (available on the website):

New Class II Medical Device Licence Application Form;
New Class III Medical Device Licence Application Form; or
New Class IV Medical Device Licence Application Form

The document entitled Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices is an alphabetical listing of all the words which appear in all the short descriptors for all the devices that are entered into the Medical Devices System (MDS). The document contains synonyms and industry words that are commonly used to describe these devices, along with their respective classifications. This document is available on the website for your reference.

Item 1: NAME OF THE DEVICE (as it appears on the label)

This is the name of the device as it appears on the product label. The device name indicated for a System, Medical device family or a Medical device group family must appear, at least in part, on the label of each of the member devices. Only one name is to be entered in Item 1.

Item 2: MANUFACTURER INFORMATION (as it appears on the label)

This is the name and address of the manufacturer of the device and the name and address to which the licence will be issued. A complete address would include: name and title of a contact person; Company ID (if known); telephone number, FAX number and e-mail address of the contact person; street name and number or P.O. Box; city, province or state; postal or zip code; and country.

Item 3: REGULATORY CORRESPONDENT INFORMATION

All regulatory correspondence will be sent to this address (if different from Item 2), but the licence will be issued to the Manufacturer. A medical device licence application can be submitted by a third party; the mailing address and name of this authorized Regulatory Correspondent will be entered here.

Item 4: INVOICING INFORMATION

This is the name, address and contact information of the party which will receive all invoicing and billing information; it may be the same as Item 2 or 3, or it may be a third party.

Item 5: QUALITY MANAGEMENT SYSTEM CERTIFICATE

Enter the certificate number and the name of the recognized registrar that has issued the certificate. A legible copy of the certificate must accompany each medical device licence application. For more information on recognized registrars and the acceptance of quality management system certificates by Health Canada visit the website.

Item 6: ATTESTATIONS

Class II Applications

Attestation of Safety and Effectiveness Requirements

As required by Sections 10 to 20 of the MDR, manufacturers of Class II medical devices must attest that they have objective evidence establishing the safety and effectiveness of their device.

Attestation of Labelling Requirements

Manufacturers of a Class II medical device must attest that their device meets the labelling requirements as required by Sections 21 to 23 of the MDR. Refer to the document Guidance for the Labelling of Medical Devices and Guidance for the Labelling of In Vitro Diagnostic Devices, which are available on the website.

Attestation of Investigational Testing for IVDDs

Manufacturers of Class II near patient IVDDs must attest here that investigational testing of their device was conducted using human subjects representative of the intended users and under conditions similar to the intended conditions of use of the device.

Near Patient Attestation

Manufacturers are to attest here that the device(s) is NOT a near patient IVDD.

A "near patient in vitro diagnostic device" means an in vitro diagnostic device (IVDD) that is intended for use outside a laboratory, for testing at home or at the point of care, such as a pharmacy, a health care professional's office or the bedside.

Signature

The manufacturer of the device must sign and date the application.

Class III and IV Applications

Evidence of safety and effectiveness

Along with the application form, a manufacturer must submit the information requested in section 32, subsection (3) or (4) of the MDR. Refer also to the document Guidance Document - Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications.

Signature

The manufacturer of the device must sign and date the application.

Item 7: PURPOSE/INTENDED USE OF DEVICE

Information provided for Item 7 is crucial to establishing the appropriate device class and should include the following:

• intended purpose, indications for use, conditions for which the device is used;
• patient population for which the device is intended including age range, if applicable, and specific diagnoses;
• anatomical and physiological particulars related to the device, if applicable;
• whether or not the device uses an energy source and/or energy is transferred to the patient.

Insufficient detail to allow verification of the classification of the device may result in the application not being accepted for review.

Item 8: LICENCE APPLICATION TYPE

The following represent the device licence application "types" a manufacturer may apply for:

A single medical device:

A medical device that is identified by a unique device name, is sold as a distinct packaged entity and does not meet the criteria for a medical device group, a medical device family, a medical device group family, a system, or a test kit. It may be offered in a range of package sizes, and is represented by a unique device name. Examples might include: an acupuncture needle, an aneurysm clip, a larynx prosthesis or dental cement.

A medical device family:

Means a group of medical devices that are made by the same MANUFACTURER, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use. Examples might include: intra vascular catheters, insulin syringes, feeding tubes or vascular access grafts.

A medical device group:

Means a medical device comprising a collection of medical devices, such as a procedure pack or tray, that is sold under a single name. Examples might include: a denture repair kit, a declotting tray, a parenteral administration kit or disposable circumcision tray.

A medical device group family:

Means a collection of medical device groups that are made by the same MANUFACTURER, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group. Examples might include: IV administration sets, dressing trays, contact lens care kits or irrigation trays.

System:

Means a medical device comprising a number of components or parts intended to be used together to fulfil some or all of the device's intended functions, and that is sold under a single name and are manufactured by the same manufacturer. Examples might include hip prostheses, knee prostheses or an ultrasonic imaging system.

Test Kit:

Means an in vitro diagnostic device that consists of reagents or articles, or any combination of these, and that is intended to be used to conduct a specific test.

For further assistance in ascertaining the appropriate licence Application type for your product, consult the Guidance for the Interpretation of Sections 28 to 31: Licence Application Type.

Item 9: PLACE OF USE

Indicate on the application form by checking the appropriate boxes.

Item 10: NON-IVD DEVICES CONTAINING DRUGS

Do not complete this item if the device is an IVDD. If the device contains a drug, which includes a pharmaceutical or biological drug, specify its brand or trade name, active ingredient(s), manufacturer, and its Drug Identification Number (DIN). If the drug does not have a DIN, an attestation that it meets acceptable standards of safety, efficacy and quality is required. Health Canada has published a document addressing the regulation of products that are comprised of both a drug and a medical device entitled Drug/Medical Device Combination Products Policy, which is available on the website.

Item 11: DEVICE HISTORY

Indicate if the device has been previously authorized for sale in Canada under the investigational testing or special access provisions of the MDR. If the device has been previously authorized for sale under the investigational testing provisions of the MDR, it will have a Device Identification (ID) number. If the device had been previously authorized for sale by the special access provisions of the MDR, it will have an Authorization number. The appropriate number must be supplied.

Item 12: IDENTIFIER OF DEVICE

Only devices, components, parts and accessories listed on the application will be considered for licensing. If additional space is required, photocopy the Item 12 page and attach it to the application form.

For a single device, enter the name of the device in the first column and enter the identifier for the device (bar code, catalogue, model or part number) in the second column.

For a medical device group, a medical device family, or a medical device group family, the names of the constituent members must be listed in the first column. Associated identifiers must be entered in the second column.

The third column is for Health Canada (HC) use only.

Refer to the definition of "identifier" in section 3 of this guidance document.

Item 13: COMPATIBILITY OF INTERDEPENDENT DEVICES

For a device intended to be used with another Class II, III, or IV device, a list of all medical devices that this device is intended to be used or function with (including their licence number), is required.

An important requirement in demonstrating safety and effectiveness of all medical devices intended to be used together is compliance with section 18 of the MDR. Section 18 requires medical devices, intended to be used together with other medical devices, to be compatible with every other medical device with which it interacts and shall not adversely affect the performance of the combination of medical devices.

Failure to submit compatibility information for interdependent medical devices has led to delays in the pre-market review of device licence applications while the Medical Devices Bureau requests the necessary information and manufacturers assemble and submit it for review.

Manufacturers are therefore reminded that the submission of evidence of compatibility for inter-dependent medical devices is a requirement under the MDR.

See also Notice to Industry - Licensing Requirements of Interdependent Medical Devices (April 30, 2002) available on the website.

Item 14: LIST OF RECOGNIZED STANDARDS COMPLIED WITH IN THE MANUFACTURE OF THE DEVICE

Refer to the documents on Recognition and Use of Standards under the Medical Devices Regulations. Health Canada uses these document to identify standards that manufacturers may utilize in demonstrating that their device complies with the safety and effectiveness requirements of sections 10 to 20 of the MDR. Proof of evidence of safety and effectiveness can be requested under Section 35 of the MDR. Note that standards not contained in the Policy may also be identified by manufacturers in support of the safety and effectiveness of their device. However, these standards should not be identified in section 14 of the application form. Instead they should be referenced by way of a letter accompanying a Class II medical device licence application or in the safety and effectiveness information submitted in support of a Class III or IV medical device licence application.

For Class II applications, the manufacturer is to list the recognized standards complied with, or attest that they possess objective evidence that the device either meets an equivalent or better standard or has been tested and alternate evidence of safety and effectiveness exists.

For Class III and IV applications, the manufacturer is to respond "YES" to one of the following statements and provide appropriate documentation:

• if the device conforms with recognized standards, the manufacturer shall list the standards and provide a Declaration of Conformity to the standard(s);
• if the device does not conform with the listed recognized standards, but instead meets an equivalent or better standard, the manufacturer shall include detailed information proving this; and
• if the device does not conform with the listed recognized standards nor does it meet an equivalent or better standard, the manufacturer shall include detailed information as evidence of the safety and effectiveness of the device(s).

Class II Applications

Items 15 to 21: These items pertain to the payment of fees. Instructions are provided on the form itself. The instructions given for each item must be carefully followed to avoid delays in the processing of your application. Consult also the Guidance Document on Cost Recovery - Fees in Respect of Medical Devices Regulations (available on the website).

Class III Applications

Item 15: REVIEW DOCUMENTS

Indicate which review documents listed on the table are included as attachments to your application. For details regarding content and format of review documents, you are requested to consult the Guidance Document - Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications (available on the website).

Items 16 to 25: These items pertain to the payment of fees. Instructions are provided on the form itself. The instructions given for each item must be carefully followed to avoid delays in the processing of your application. Consult also the Guidance Document on Cost Recovery - Fees in Respect of Medical Devices Regulations (available on the website).

Class IV Applications

Item 15: REVIEW DOCUMENTS

Indicate which review documents listed on the table are included as attachments to your application. For details regarding content and format of review documents, you are requested to consult the Guidance Document – Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications (available on the website).

Item 16: DEVICES CONTAINING BIOLOGICAL MATERIAL

This section of the application form must be completed in detail. If additional space is required, photocopy the Item 16 page and attach it to the application form.

Items 17 to 26: These items pertain to the payment of fees. Instructions are provided on the form itself. The instructions given for each item must be carefully followed to avoid delays in the processing of your application. Consult also the Guidance Document on Cost Recovery - Fees in Respect of Medical Devices Regulations (available on the website).