Regulatory Open Forum

Hi Everyone!

My company has submitted a Class II medical device license request to Health Canada. After our initial submission, Health Canada posed some questions to which we promptly replied. According to Health Canada, the regulatory screening process is expected to take 12 days. Now, I'm curious about what will occur after this stage. Will there be further rounds of questions and responses, or will Health Canada make a determination based on the current information and either accept or reject the application? Thanks.

Hi,

Class II medical devices undergo a two-step screening process with Health Canada. The first is the Administrative screening, which checks for administrative completeness of submitted documents. Incomplete applications with respect to administrative content will result in a request for outstanding information. The second is the Validation screening which examines the validity of the submitted regulatory information ( current stage of your application). If deficiencies are discovered during this step, you will be issued a Screening Deficiency. From the date of the Screening Deficiency, you will have 10 calendar days to provide the needed information. Upon receipt of such information, a new 15-day calendar will be established. Failure to reply to the Screening Deficiency within the time limit indicated, or providing a deficient or partial response, will result in the application being rejected. All applications that meet the validation screening requirements will be passed on for subsequent license generation and issue.

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Mbaboh Ngah-Wanneh

Graduate student Medical Device Regulatory Affairs
St Cloud state University @Plymouth
United States
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