France · Haute Autorité de santé · Software as a medical device
Review target
60 days
regulation
Legal time limit
-
Not published
Steps
5
4 requirements
Application fee
-
A coverage route, not a marketing authorisation. CE-marked digital medical devices that are presumed innovative, either therapeutic or for remote monitoring, can be reimbursed for one year, not renewable, while the company seeks standard listing. The HAS committee gives its opinion within 60 days of a complete file, and an interoperability and security certificate is needed in parallel. A CE-marked, presumed innovative digital medical device with a therapeutic purpose or for remote monitoring.
The official review target is 60 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Qualification opinion (class I only); 2. File in parallel; 3. HAS committee opinion (60 days); 4. Ministerial decision on early coverage; 5. File for standard listing (183 days).
Outcome: One year of exceptional reimbursement while the standard listing application is examined. Valid for 1 years.
Legal basis: Decree No. 2023-232 of 30 March 2023
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 243 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. Committee opinion after a complete file. This is an official target, not an actual review time. | 60 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in France: National declarations for medical devices, Derogation for a device without CE marking. See all routes on the France page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.