Guidance on managing applications for medical device licences: Screening process
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- Administrative screening
- Regulatory screening
- Technical screening
- Withdrawal letter
- Administrative processing
Administrative screening
Health Canada’s Medical Devices Directorate 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.
The process map for administrative screening is included in Appendix A (see Figure 1).
Acceptable applications
Once your application is found to be administratively complete, it is assigned a unique application number and forwarded for regulatory screening. If your application is a new or amendment Class II application, a new private label application, or a new or amendment (significant change) Class III or IV application, you will be notified at this stage.
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:
- device risk classification
- licence application type
- manufacturer's quality management system certification
- device labelling and
- supporting information (information that's not scientific evidence)
To learn about these regulatory components, consult:
The process maps for the screening period are included in Appendix A (see Figures 2 and 3).
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.
A new or amendment (significant change) Class III or IV application is also subject to technical screening.
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 associations between active applications, or between active applications and existing licences).
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. Your response to the SDL is acknowledged upon receipt. 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
A new or amendment (significant change) Class III or IV application identified as deficient following regulatory screening typically undergoes technical screening before an SDL is issued.
In some cases, if an application has major regulatory deficiencies (for example, relating to device classification or the quality management system certificate), Health Canada may issue an SDL before technical screening. If the regulatory deficiencies are resolved, the application will still go through technical screening.
In both scenarios, you have 15 calendar days from the date of the SDL to submit the requested information. Your response to the SDL is acknowledged upon receipt. A new 15-calendar day screening period starts when we receive an administratively complete response ( 12 days for screening and 3 days for administrative processing).
Learn more about technical screening.
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. Your response to the SDL is acknowledged upon receipt. 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:
- fail to submit the information requested in the SDL within the time specified or
- submit incomplete or deficient information
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.
The process map for the screening period is included in Appendix A (see Figure 3).
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).
A screening acceptance letter (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 regulatory screening, technical screening, or both, 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 upon receipt. A new 15-calendar day screening period starts when we receive an administratively complete response ( 12 days for 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:
- fail to submit the information requested in the SDL within the time specified or
- submit incomplete or deficient information
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
You may withdraw your MDL application at any time during the screening process by filing a withdrawal request using the Regulatory Enrolment Process (REP). Learn about the REP for medical devices.
An acknowledgement is issued once we receive the request.
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:
- generate and issue the appropriate regulatory decision letter or
- issue an MDL or amended MDL