| Classification | Registration | Renewal | Changes |
Implementation Schedule
|
| Class I |
Declarative |
Declarative
|
Declarative |
Applied and in effect
|
| Class II FDA |
– Regular Route
– Fast route for FDA-approved devices that have been in use in the U.S in the last 4 months, will be registered within 45 business days unless a decision is actively made not to approve.
|
Declarative
|
– Declarative (non-substantial)
– On a fast route (substantial)
|
– Changes via declaration starting April 1, 2024
– Non-substantial changes via declaration starting April 1, 2024
– Fast route for registration and substantial changes starting April 1, 2024
|
| Class IIa EU (*) |
– Regular route
– Fast route for devices approved by a recognized country that have been in use in such country for the last 4 months will be registered within 45 business days unless a decision is actively made not to approve.
|
Declarative
|
– Declarative (non-substantial)
– On a fast route (substantial)
|
– Changes via declaration starting April 1, 2024
– Non-substantial changes via declaration starting April 1, 2024
– Fast route for registration and substantial changes starting April 1, 2024
|
| Class IIb EU (**) |
– Regular route
– A fast route for devices approved in two independent regulatory authorities (e.g., EU and FDA), that have been in use in a recognized country for the last 6 months, will be registered after 60 business days unless a decision is actively made not to approve.
|
Declarative, accompanied by a post-marketing tracking report
|
– Declarative (non-substantial)
– On a fast route (substantial)
|
– Changes via declaration starting April 1, 2024
– Non-substantial changes via declaration starting April 1, 2024
– Fast route for registration and substantial changes starting April 1, 2024
|
| Class III | Regular route |
Submission of an application, accompanied by a post-marketing tracking report
|
Declarative (non-substantial)
|
Non-substantial changes via declaration starting April 1, 2024
|
(*) Including laboratory equipment IVDR (B) or the equivalent per the IVDD directive.
(**) Including laboratory equipment IVDR (C) or the equivalent per the IVDD directive.
Please note that the above is merely a short summary of the subject matter, and does not cover all relevant provisions of the Reform.
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The content in this communication is provided for informational purposes only and is not intended to be comprehensive. It does not serve to replace professional legal advice required on a case by case basis.
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For further questions, please get in touch with:
Hili Cohen, Head of the Life Science Practice, International and Hi-Tech Department
Ofir Goldstein, Associate, Life Science Practice, International and Hi-Tech Department
Shira Shick, Associate, Life Science Practice, International and Hi-Tech Department
