Guidance on managing applications for medical device licences: Review process
On this page
- Target performance standards
- Acceptable applications
- Clarification request
- Deficient applications - additional information letter
- Unsolicited information
- Pause the clock
- Withdrawal letter
- Refusal letter
- Administrative processing
- Review reports
Target performance standards
Once a screening acceptance letter (SAL) is issued, new and amendment (significant change) Class III and IV medical device licence (MDL) applications enter the review queue.
The target performance standard for review (number of days from the date of the SAL to the date of the first decision, including 3 days for administrative processing) is:
- 60 calendar days for new and amendment (significant change) Class III applications
- 75 calendar days for new and amendment (significant change) Class IV applications
The process map for the review period is included in Appendix A (see Figure 4).
Acceptable applications
Our goal is to issue or amend an MDL within the target performance standards if the device that’s the subject of the application meets the applicable requirements of the Medical Devices Regulations (regulations). Note that an MDL could also be issued with terms and conditions.
Learn more about terms and conditions for medical devices.
Clarification request
During the review process, we may ask you to clarify or add more details to the information or data in your MDL application. To be considered a clarification request, the information that's requested will be minor, such as to clarify:
- if the evidence provided in the test report includes the subject device
- the software version of the device used in testing
We will not ask for new information as part of a clarification request. There is no limit to the number of clarification requests that may be issued for 1 application. We will not, however, repeat the same request.
You may have as few as 2 calendar days to submit the requested information. The review clock does not stop with a clarification request.
We may issue an additional information (AI) letter if the requested information is not provided within the specified timeframe or the information provided is deficient or incomplete.
Deficient applications - additional information letter
During or following a review of a new or amendment (significant change) Class III or IV MDL application, we will notify you of any deficiencies or missing information in an AI letter. The review clock is stopped from the date of the letter.
An acknowledgement is issued once we receive the requested information in response to the AI letter.
Your application is then placed back in queue for review and a new 45-calendar day review period begins (including 3 days for administrative processing). We reserve the right during this stage to ask for clarification of the information submitted.
The information above applies to both types of AI letters described below.
Additional information - deficiency letter
An additional information - deficiency (AI-D) letter is sent if we find the application is incomplete or deficient after reviewing it. The letter will specify the issues that make the application deficient or incomplete.
You have 60 calendar days from the date of the letter to submit the requested information.
Usually, no more than 2 AI–D letters are issued, but additional letters may be issued in certain situations (for example, if the review of a response to a second AI–D letter identifies a new deficiency, such as an oversight in the response or a misinterpretation of the request).
Additional information - noncompliance letter
An additional information - noncompliance (AI-N) letter is sent if we:
- identify significant deficiencies or omissions that make it challenging to continue reviewing the application
- find you have made a false or misleading statement in the application
You have 10 calendar days from the date of the letter to submit the requested information. (Note: The response timeline is 50 calendar days shorter than for an AI–D scenario and the review of the application is not complete when an AI–N letter is issued.)
More than 1 AI-N letter may be issued for an application and an AI-N letter may be followed by an AI-D letter or a refusal letter.
Unsolicited information
During the review process, you may submit:
- updated information on the regulatory status of your medical device in other countries and
- updated information on the safe use of the device
- includes updated safety-related labelling and problem reports submitted to other regulatory agencies
The above unsolicited information does not include significant changes to the device under review or to the scope of the review (this requires a new application).
When filing unsolicited information, you should clearly indicate it is unsolicited and reference the relevant application number in the cover letter so we can forward this new information to the appropriate review team.
Pause the clock
Pause the clock is a mechanism that allows for the clock to be formally paused under certain circumstances. When there’s a pause, the target date is changed to account for the amount of time the clock has been paused.
The clock can pause only in the following cases:
- For a combination product that is subject to the Medical Devices Regulations, the device clock could pause when the review of the device portion of the product results in a positive recommendation, but the review of the drug portion is ongoing.
- You are notified of the pause and the clock resumes when the drug review is completed.
- For linked MDL applications where different timelines apply (for example, a Class III implantable device and its associated Class II delivery system, where a system licence application type may not be possible), the clock could pause when the review of the application with the shorter timeline is complete, but the review of the linked device application is outstanding.
- You are notified of the pause and the clock resumes when we have completed the review of the linked device application.
Learn about combination products.
Withdrawal letter
You may withdraw your MDL application at any time during the review process by submitting 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.
Refusal letter
Before a decision is made, you are given an opportunity to address deficiencies in your MDL application using the AI letter mechanism.
We may issue a refusal letter if you:
- fail to submit the information requested in the AI letter within the time specified
- submit an incomplete or deficient response
- fail to comply with the regulations or any provisions of the Food and Drugs Act relating to medical devices or
- make a false or misleading statement
The refusal letter contains the specific reasons or deficiencies that resulted in the decision to refuse to issue or amend an MDL.
You may resubmit your application at any time. Refusal 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 refusal decision to be reconsidered. Learn about the reconsideration process.
Administrative processing
New and amendment (significant change) Class III and IV MDL applications are subject to a 3-day administrative processing period. During this period, we will:
- generate and issue the appropriate regulatory decision letter or
- issue an MDL or amended MDL
Review reports
If you receive a refusal letter or choose to withdraw your application after receiving an AI letter, you may request the review reports through the REP. We try to provide a copy of the requested reports within 15 calendar days of receiving the request.
Learn about the REP for medical devices.