France - Medical Devices (MED)France – Medical Devices

Overview

(total market size = (total local production + imports) - exports)
data source: SNITEM “Panorama de la Filière Industrielle des Dispositifs Médicaux en France en 2019 :
 (Figures in USD millions; * indicates unofficial estimates. Year to year figures adjusted for varying exchange rate.)
 
The medical device market in France had an estimated turnover of €31.2 billion for the year 2019. The market turnover for medical devices exported from France is estimated at €8.9 billion, which is 26% of the total market. The market is expected to see an annual growth of about 2% for the next several years.

There are over 1,300 medical device firms in France. One-third of these firms are of foreign origin. Although they only account for one-third of the number of enterprises, foreign enterprises bring in two-thirds of the total monetary turnover. American enterprises alone bring in 22% of the total turnover.

As opposed to other medical sectors such as pharmaceuticals where large multi-national corporations often dominate the market, the medical device industry is mostly composed of niche-market producers. Out of the 1,300 enterprises in France, 92% of them are SMEs, of which, 88% exclusively produce medical devices. The medical device sector employs approximately 85,000 people.

The best prospects for medical equipment can be found in newly-developing sectors such as non-invasive surgery, orthopedics, and disposable medical equipment. Healthcare professionals in France are highly optimistic about the success of new medical technology. One example of such technology is telemedicine, which is expected to have a major impact on medical care institutions in the coming years.

There has been a steady growth of innovative medical procedures in France, such as same-day surgery. This growth is expected to benefit American medical equipment manufacturers who produce highly innovative devices, as well as those who offer products and services focused on reducing healthcare costs.
 
Best practices
To export medical devices to France, U.S. companies should either have an agent / distributor or set up a subsidiary.  For smaller and medium size companies, it is preferable to first select an agent / distributor in order to have a better sense of the market share that can be obtained in France.  The creation of a fully-owned subsidiary can be planned at a later stage. Medical devices in the French market, whether imported products or domestically manufactured lines, are subject to the following requirements:

• Medical devices are required to obtain the CE Mark

• Medical devices are required to have French-language directions Leading Sub-Sectors

Diagnosis
The diagnostic sub-sector represents approximately 34% of the total medical device market in France. State-of-the-art diagnostic medical imaging systems are in high demand. Uses for diagnostic technology already exist for pediatrics, cardiovascular care, digestion, urology, and spinal/neurological treatment. As these devices use trusted and versatile technology, demand for diagnostic equipment will continue to grow. Health care professionals are very interested in a feature of medical imagery equipment known as "image networking". Image networking allows a healthcare professional to compare an image of a current patient to hundreds of previous cases using an image data bank.

Rehabilitation
The rehabilitation sub-sector represents approximately 25% of the total medical device market in France. It includes all types of devices designed to help those recovering from illness or treatment. Like many European markets, France has a growing elderly populationwith a higher need for rehabilitation products. A large portion of this sub-sector is made up of disposable medical equipment such as incontinence products, wound care products, and items designed to prevent bed sores.

Surgery
The surgical instrument and supplies sub-sector represents approximately 18% of the total medical device market in France. Recent innovations in the field of non-invasive surgery could potentially have a significant impact on everyday hospital practice. Non-invasive surgery devices offer superior results and present a significantly reduced risk to patients.
Technical aids
The French market for medical prosthesis accounts for approximately 7% of the total medical device market. This market is characterized by a strong growth potential for innovative internal prostheses such as knees, hips, ligaments, and elbows. Innovative technical aids in the fields of audiology, dialysis, and respiration are also in high demand.
 
Intensive care
Intensive care equipment like respiratory monitors, pumps, and incubators represent about 9% of the total medical device market. Demand from both public and private hospitals for cutting-edge intensive care equipment and supplies are increasing. U.S. suppliers of this type of equipment should benefit from the increased demand.

Hygiene
The hygiene sub-sector represents approximately 5% of the total medical device sector in France. Patient and medical personnel safety is a growing concern to medical personnel and to the public. Best prospects in this sector will include  products that make it easier to adhere to stringent personnel safety requirements. Products with a focus on protection from and preventing the spread of AIDS and other contagious diseases are in particularly high demand.
 
Opportunities
Implementing controls on health care spending is a key objective of the French government. Decreased spending has led to a decline in the demand for traditional hospital-care equipment. At the same time, demand has grown for medical equipment that can help ensure shorter and less-frequent hospital stays. The increasing need for age-related health care equipment will continue to bring new prospects for U.S. suppliers of innovative medical devices.
Companies that specialize in healthcare IT solutions or electronic medical records are also in high demand. France has developed an electronic card (Carte Vitale) for each patient as a way to process government reimbursement electronically. There are plans to update these cards in the future so that they carry electronic medical records in addition to payment information.
 
Web Resources
Approval and Testing
G-MED (Groupement pour l'évaluation des dispositifs médicaux)
National agency for the evaluation of medical equipment
G-MED
 
Trade Association
Syndicat National de l'Industrie des Technologies Médicales - S.N.I.T.E.M.
Medical equipment trade association
S.N.I.T.E.M.
 
National Authority for Health
HAS (Haute Authorité de Santé)
National agency for the evaluation of medical equipment and medical practices
HAS
 
Safety Agency
ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)
National agency for the safety of pharmaceuticals and health products
ANSM
 
Pricing Committee 
CEPS (Comité Economique des Produits de Santé)
Pricing committee for pharmaceuticals and medical devices 
CEPS
 
Public Hospitals
FHF (Fédération Hospitalière de France)
Public Hospitals Federation
FHF
 
Private Hospitals
FHP (Fédération de l’Hospitalisation Privée)
Private Hospitals Federation
FHP
 
Contact:
Alain Levy
U.S. Embassy - U.S. Commercial Service Commercial Specialist:
Alain.Levy@trade.gov
Tel: +33(0)1 43 12 70 14
Export.gov/France