The French decree regarding the list of medical devices for which advertising to healthcare professionals (and to the public) shall obtain a prior authorization of ANSM (National Safety Agency of Medicines and Health Products), was published on May 09, 2012. Such authorization is already applicable since January 1st 2013.
For reimbursable Medical Devices (MD) advertising to the public is authorized only for class I and IIa. For non-reimbursable MD advertising is possible and subject to authorization a priori (if on the high-risk MD list) or a posteriori.
If advertising to healthcare professionals, the same will apply indifferently for reimbursable and non-reimbursable MD.
Regarding IVDMD (in-vitro diagnostic medical devices), advertising is possible and subject to authorization a priori (if on the high-risk MD list) or a posteriori. There is a distinction for self-test IVDMD for which authorization is required a priori.
What is the meaning of advertising in this context ? To summarize: all communication except label, IFU, correspondence intended to answer specific questions, field service notice, etc…
So, is subject to prior authorization by ANSM all advertising directed at health professionals for the following medical devices:
Implantable heart defibrillator, Implantable heart defibrillator leads, Implantable heart pacemakers and accessories, Implantable heart stimulating leads, Coronary Stents, intracranial stent.
Breast implants, Dermal fillers.
Ankle prosthesis, Knee prosthesis, Hip prosthesis, Shoulder prosthesis.
Intraocular lenses.
Laser generators for surgery
As mentioned earlier for the public, dermal fillers and self-test diagnostic IVDMD are concerned.
ANSM will have a period of 2 months from the date of receipt of the application to notify the company of a favorable opinion or a refusal. Beyond this period and if no response from ANSM, the application is considered accepted. The validity of the authorization is five years. The information is published on ANSM website:
One of the consequence of this decree could be to delay the launch of the new devices included into the above mentioned list by 60 days without waiting for the new European Regulation.
If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea.
