French Approval Process

Regulations concerning the review and approval of clinical research studies are published on the website of the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). The French regulations integrate the transposition of the European Directive on Medicinal Products 2001/20/EC and on Medical Devices 93/42/EEC.

Clinical trial start-up time: 3.5 months.

French Pre-Market Registrations

Regulations in France require all medical devices to receive a Reference Study Number through registration to ANSM, This number is intended to identify each Research carried out in France and pivotal to gettting studies underway. This process is comprised of 4 parts:

• Part 1: Administrative Dossier (Presentation)

• Part 2: Biomedical Research Dossier

• Part 3: Technical Dossier: presents the data relating to products used within the framework of the research

• Part 4: Other Documents/Enclosures

Investigators and Sites

France hosts many sites, including 11 newly associated sites. Investigators are experienced in the necessary submissions and additional approvals for medical devices to achieve the CE mark. Moreover, our French CRAs are well acquainted with the many regulatory bodies and competent authorities, which leads to excellent relations with the investigators and excellent quality of the data.