Class 2, non-in vitro diagnostic devices (nIVD) and in vitro diagnostic devices (IVD), new and amendment applications

(PDF version, 325 KB, 7 pages)

On this page:

1 - Regional administrative

Folder name: 1-REG ADMIN

Note: No files or content should be included at this level. Only sub-folders of this folder should contain documents.

1.01 - Cover Letter

Folder name: 1.01-Cover Letter

Health Canada guidance

Generally cover letters are not required. In special circumstances where content is considered important but does not belong elsewhere in the application, it can be included in a cover letter.

Classification

New and amendment applications:

  • Conditionally required - If information needs to be included that does not appear somewhere else in the application

1.04 - Application form/administrative information

Folder name: 1.04-Application Form-Administrative Info

Health Canada guidance

A copy of the relevant Health Canada Application and Fee Forms for the application - refer to www.canada.ca for the most up to date forms.

Classification

New and amendment applications:

  • Required

1.06 - Quality management system, full quality system or other regulatory certificates

Folder name: 1.06-QMS Full QS or Other Regulatory Certs

Health Canada guidance

This subsection includes a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured satisfies CAN/CSA ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purposes. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations recognized by the Minister in accordance with Section 32.1 of the Medical Devices Regulations.

Classification

New licence applications:

  • Required

Amendment licence applications:

  • Not required

1.09 - Pre-submission correspondence and previous regulator interactions

Folder name: 1.09-Pre-Submission Correspondence-Previous Regulator Interactions

Health Canada guidance

During the product lifecycle, pre-submission correspondence, including teleconferences or meetings, may be held between the regulator and the applicant. Further, the specific subject device may have been subject to previous regulatory submissions to the regulator or correspondence to confirm device risk class. A summary of these interactions and copies of any meeting minutes or emails are to be provided. The contents should be limited to the subject device as similar devices are addressed in other areas of the submission.

Note: The scope of this section is limited to the particular regulator to which the submission is being submitted (i.e. Health Canada does not need pre-submission information relating to interactions with the USFDA).

Classification

New and amendment applications:

  • Conditionally required - If applicable

2 - Submission context

Folder name: 2-CONTEXT

Note: No files or content should be included at this level. Only sub-folders of this folder should contain documents.

2.04 - Device description

Folder name: 2.04-Device Description

Note: No files or content should be included at this level. Only sub-folders of this folder should contain documents.

Health Canada guidance

No content at this level.

Classification

New licence applications:

  • Not required

Amendment licence applications:

  • Optional

2.04.04 - Reference and comparison to similar and/or previous generations of the device

Folder name: 2.04.04-Ref-Comparison to Similar and-or Previous Gen

Health Canada guidance

Comparison table showing similarities and differences to currently licensed devices.

Classification

New licence applications:

  • Not Required

Amendment licence applications:

  • Optional

5 - Labelling and promotional material

Folder name: 5-LABELLING

Note: No files or content should be included at this level. Only sub-folders of this folder should contain documents.

5.02 - Product/package labels

Folder name: 5.02-Product-Package Labels

Health Canada guidance

Samples of the primary and secondary packaging labels but exclusive of labels for shipping.

Notes:

  1. All labelling must be provided in English or French, both official languages are to be available upon request.
  2. Labelling for near-patient devices must also be provided in French and English.

Classification

New and amendment applications:

  • Conditionally required - If applicable

5.03 - Package insert/instructions for use

Folder name: 5.03-Package Insert-Instructions for Use

Health Canada guidance

Package insert/instructions for use included in the package, when required or provide support for why this element is not applicable.

Notes:

  1. All labelling must be provided in English or French, both official languages are to be available upon request.
  2. Labelling for near-patient devices must also be provided in French and English.

Classification

New and amendment applications:

  • Conditionally required - If applicable

5.04 - e-labelling

Folder Name: 5.04-e-labelling

Health Canada guidance

  1. For eligible medical devices and stand-alone software, the applicant needs to identify which form of e-labelling is being used in case of e-labelling (e.g. electronic storage system or built-in system, website).
  2. Provide details of risk management in relation to e-labelling. If this is part of the overall risk management, refer to it here.
  3. A description of the procedure and operations on providing IFU's when requested.
  4. Provide written information for user Information on webpage where IFU and further information can be found in relevant languages.
  5. Description on how the requirements detailed for the website have been met.

Classification

New and amendment applications:

  • Optional

5.05 - Physician labelling

Folder name: 5.05-Physician Labelling

Health Canada guidance

Labelling directed at the physician other than the package insert, such as the surgical manual.

Classification

New and amendment applications:

  • Conditionally required - If applicable

5.06 - Patient labelling

Folder name: 5.06-Patient Labelling

Health Canada guidance

Labelling directed at the patient other than the package insert, such as informational material written to be comprehended by the patient or lay caregiver.

Classification

New and amendment applications:

  • Conditionally required - If applicable

5.07 - Technical/operators manual

Folder name: 5.07-Technical-Operator Manual

Health Canada guidance

Labelling directed the technical users and operators of medical devices focusing on the proper use and maintenance of the device.

Classification

New and amendment applications:

  • Conditionally required - If applicable

5.08 - Patient file stickers/cards and implant registration cards

Folder name: 5.08-Patient File Stickers-Cards-Implant Registration Cards

Health Canada guidance

  1. Stickers/cards intended to be place in the patient's chart identifying the implant (e.g. serial #, lot#, make, model).
  2. If applicable, implant registration cards.
  3. The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject device.

Classification

New and amendment applications:

  • Conditionally required - If applicable

5.09 - Product brochures

Folder name: 5.09-Product Brochures

Health Canada guidance

  • Draft product brochures available at the time of application.
  • The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject device.

Classification

New and amendment applications:

  • Conditionally required - If applicable

5.10 - Other labelling and promotional material

Folder Name: 5.10-Other Labelling-Promotional Material

Health Canada guidance

Heading for other information that may be important to the submission but that does not fit in any of the other headings of this chapter.

Classification

New and amendment applications:

  • Conditionally required - If applicable
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