Draft guidance on managing applications for medical device licences: Refiled applications
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Introduction
You may refile a medical device licence (MDL) application that was withdrawn previously or an application that received a rejection letter or refusal letter. A refiled application is considered a new application.
You are notified once your refiled application is found to be administratively complete and is assigned a new application number. A refiled application is managed according to this guidance document and is subject to new policies, procedures and guidance documents that may be in effect at the time of refiling.
Fee status: Refiled applications are subject to the same application fees and fee schedules as original applications.
Refiling within 6 months
If an MDL application is refiled within 6 months of a refusal letter or withdrawal letter, you have the option to submit only the material requested in the outstanding AI letter or listed in the refusal letter. However, the original material previously filed must be cross-referenced.
If you cross-reference the original material, you must in the refiled application:
- certify the original material remains unchanged
- identify new and previously submitted information in the table of contents section
Refiling after 6 months
If an MDL application is refiled after 6 months of a refusal letter or withdrawal letter, you must submit a completely new application (no cross-referencing to previously submitted material is allowed). This approach reflects the dynamic nature of medical device development.
In the refiled application, you should:
- indicate the components that were previously filed
- certify the information that remains unchanged
- highlight any revisions
Refiling after a rejection letter
If an MDL application is refiled following a rejection letter, you must submit a completely new application (no cross-referencing to previously submitted material is allowed).