My application is evaluated by the commission and the ANS
Prerequisites
I have received the acknowledgement of receipt (AR) from the ministries.
11.a ANS evaluates my evidence
Evaluation
ANS
ANS examines my evidence on the Convergence platform
Delay
60 days
The NSA has a maximum of 60 days from the date of submission of ALL evidence to evaluate the file. Please note: this is not a deadline but an analysis time.
During this phase, the ANS may contact me via the Convergence platform's internal messaging system if it needs to provide clarification on the evidence.
If the documents supplied are incomplete or do not comply with the requirements
Delay
30 days
I am being solicited by ANS.
If I do not transmit the requested elements within the allotted time, my registration request is at least deprioritized and in some cases, is deemed abandoned.
Please note:Application processing time will be tracked and time-stamped on the application management tool. Evaluation time on the ANS side is not counted as soon as additional information is pending on the ENS side.
11.b The CNEDiMTS examines my application
Evaluation
CNEDiMTS
My application on the Sésame platform is examined by the CNEDiMTS
Delay
60 days from AR
Please note:The CNEDiMTS issues its opinion within 60 days, upon acknowledgement of receipt of a complete file.
If the parts supplied do not contain all the necessary information
Delay
30 days to complete your application
I am notified by the ministers in charge of health and social security, where applicable on the proposal of the CNEDiMTS, of the list of additional elements to be provided.
If I do not send the requested elements within 30 days of receiving the list of required elements, the application is deemed abandoned.
12.a I receive a positive opinion and certification
Evaluation
ANS
I receive a favorable opinion from the ANS and obtain the certificate of conformity.
I receive my conformity certification documents by e-mail as well as information for the rest of the conformity certification procedure for digital medical devices.
12.b I receive the notice from CNEDiMTS
Evaluation
CNEDiMTS
I receive a notice from the commission
Delay
60 days
The commission's opinion is sent to me within 60 days.
I receive the CNEDiMTS opinion, favorable or unfavorable, via the Sésame platform.
It is published on the HAS website and also sent to the relevant national professional councils (CNP) if it concerns remote medical monitoring.