What are the differences between brand name and generic listings?
The operator of a telemonitoring digital medical device (DMD) must apply for registration onthe list of medical telemonitoring activities (LATM). There are two types of open registration application.
The 2 types of LATM applications
1. Generic online registration
It concerns several types of DMN that are characterized by common technical specifications and precise indications without mention of trade or company names. These generic lines are described by decree after advice from the CNEDiMTS.
2. Brand name registration
At the operator's request, remote monitoring activity is based on a single DMN described by its brand name or trade name. This type of registration is required for a DMN:
- Whose indication or technical specifications do not correspond to any existing generic line
- And/or which claims superior interest in terms of efficiency or organizational impact compared with other activities already supported.
Steps to reimburse your remote monitoring solution depending on your choice of registration
Generic line
If I come from ETAPES, I can apply for a generic line
- I demonstrate that I am eligible byobtaining the ANS certificate of compliance with interoperability and security reference systems and technical specifications
- I make an application to obtain an individual code from the ministers to be covered
.
Brand name
- I demonstrate that I am eligible by obtaining the ANS certificate of compliance with the interoperability and safety repositories
- I submit the proofs of benefit for my DMN which will be assessed by the CNEDiMTS
- I submit my registration file on the HAS's Sésame platform
.