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Draft guidance on managing applications for medical device licences: Screening process

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Administrative screening

Health Canada's Medical Devices Directorate (MDD) screens all medical device licence (MDL) applications for administrative completeness. For example, we check that the fee form is complete and the folder structure, file naming convention and file formats are acceptable.

Our goal is to complete this part of the screening process within 4 calendar days of receiving an application.

Acceptable applications

You are notified once your application is found to be administratively complete and is assigned a unique application number. Your application is then forwarded for regulatory screening.

Fee status: For new and amendment Class II applications and new and amendment private label applications, 100% of the applicable fee is charged once an application is considered administratively complete.

Deficient applications

We will issue a request for outstanding information for an administratively deficient application. You have 10 calendar days to provide this information.

Rejection letter

We may issue a rejection letter if you fail to respond to a request for outstanding information within the specified timeframe or the information that's provided is deficient or not complete.

You may resubmit your application at any time. Rejection of the previous application does not prejudice refiling. We will process the refiled application as a new application. Learn more about refiling an application.

Fee status: We do not charge fees if an application is rejected at the administrative screening stage.

Regulatory screening

Administratively complete MDL applications are examined for validity of the regulatory information. In this stage, we validate the:

Learn about licence application types.

Acceptable applications

New and amendment Class II applications, and new and amendment private label applications

New and amendment Class II applications, and new and amendment private label applications are examined for validity of the regulatory information. Our goal when we receive an administratively complete application is to complete this examination within 15 calendar days (12 days for regulatory screening and 3 days for administrative processing).

We intend to issue an MDL (or amended MDL) within this period if the device that's the subject of the application meets the applicable requirements of the Medical Devices Regulations (regulations).

Learn more about target timelines and performance standards.

New and amendment (significant change) Class III and Class IV applications

New and amendment (significant change) Class III and IV applications are examined for validity of the regulatory information. Our goal when we receive an administratively complete application is to complete this examination within 5 calendar days.

After regulatory screening, these applications go through the technical screening stage.

Following the technical screening stage and if the new or amendment (significant change) Class III or IV application is acceptable, we issue a screening acceptance letter (SAL).

Learn more about technical screening.

Minor change applications

Minor change applications are examined for validity of the regulatory information. Our goal when we receive an administratively complete application is to complete this examination within 7 calendar days (4 days for regulatory screening and 3 days for administrative processing).

We intend to issue an amended MDL within this period if the device that's the subject of the amendment application meets the applicable requirements of the regulations.

Clarification request

You may be asked to clarify or add more details to information provided in an application at any point during the regulatory screening process. To be considered a clarification request, the information that's requested will be minor (for example, to clarify the Global Medical Device Nomenclature (GMDN) codes assigned to devices).

We will not ask for new information as part of a clarification request. There is no limit on the number of clarification requests that we may issue for 1 application. We will, however, not repeat the same request.

You may have as few as 2 calendar days to submit the requested information. The clock does not stop when we issue a clarification request.

A screening deficiency letter (SDL) may be issued if the requested information is not provided within the specified timeframe or the information provided is deficient or incomplete.

Deficient applications - screening deficiency letter

New and amendment Class II applications, and new and amendment private label applications

An SDL is issued when we identify deficiencies while examining the validity of a new or amendment Class II application or new or amendment private label application.

You have 15 calendar days from the date of the SDL to submit the requested information. A new 15-calendar day screening period starts when we receive an administratively complete response (12 days for regulatory screening and 3 days for administrative processing).

New and amendment (significant change) Class III and Class IV applications

An SDL is issued when we identify deficiencies during the regulatory or technical screening of a new or amendment (significant change) Class III or IV application.

You have 15 calendar days from the date of the SDL to submit the requested information. Your response to the SDL is acknowledged. A new 15-calendar day screening period starts when we receive an administratively complete response (5 days for regulatory screening, 7 days for technical screening and 3 days for administrative processing).

Minor change applications

An SDL is issued when we identify deficiencies while examining the validity of a minor change application.

You have 15 calendar days from the date of the SDL to submit the requested information. A new 7-calendar day screening period starts when we receive an administratively complete response (4 days for regulatory screening and 3 days for administrative processing).

Rejection letter

Before a decision is made, you are given an opportunity to address deficiencies in your application using the SDL mechanism.

We may issue a rejection letter if you:

You may resubmit your application at any time. Rejection of the previous application does not prejudice refiling. The refiled application is processed as a new application. Learn more about refiling an application.

As an alternative, you may ask for the decision to reject your application to be reconsidered. Learn about the reconsideration process.

Technical screening

New and amendment (significant change) Class III and Class IV MDL applications are screened for technical completeness.

Our goal is to ensure the necessary scientific evidence used to support the application is included. The required scientific evidence is defined in the regulations and described in various guidance documents.

Learn about supporting evidence requirements.

Acceptable applications

After regulatory screening, new and amendment (significant change) Class III and IV applications are screened for technical completeness. Our goal when we receive an administratively complete application is to complete the screening within 15 calendar days (5 days for regulatory screening, 7 days for technical screening and 3 days for administrative processing).

An SAL is issued when the information and material submitted is considered acceptable for review.

Fee status: For new and amendment (significant change) Class III and IV applications, 100% of the applicable fee is charged when an SAL is issued.

Deficient applications - screening deficiency letter

An SDL is issued when we identify deficiencies during the screening of a new or amendment (significant change) Class III or IV application. An application is deficient if the required information is not provided or does not contain enough detail. The information that's required is defined in the regulations and described in various guidance documents.

Learn about submission requirements.

You have 15 calendar days from the date of the SDL to submit the requested information. Your response is acknowledged. A new 15-calendar day screening period starts when we receive an administratively complete response (5 days for regulatory screening, 7 days for technical screening and 3 days for administrative processing).

Rejection letter

Before a decision is made, you are given an opportunity to address deficiencies in your application using the SDL mechanism.

We may issue a rejection letter if you:

You may resubmit your application at any time. Rejection of the previous application does not prejudice refiling. The refiled application is processed as a new application. Learn more about refiling an application.

As an alternative, you may ask for the decision to reject your application to be reconsidered. Learn about the reconsideration process.

Fee status: For new and amendment (significant change) Class III and IV applications, 10% of the applicable fee is charged when a rejection letter is issued.

Withdrawal letter

During the screening process, you may withdraw your MDL application by informing MDD of your intent in a withdrawal letter. Your withdrawal letter is acknowledged.

You may resubmit your application at any time. Withdrawing the application does not prejudice refiling. The refiled application is processed as a new application. Learn more about refiling an application.

Fee status: For new and amendment (significant change) Class III and IV applications, 10% of the applicable fee is charged when an application is withdrawn (after the SDL is issued but before the application is accepted into review).

Administrative processing

There is a 3-day administrative processing period for all MDL applications. During this period, we will:

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