France Medical Device Registration

Medical Device Regulations in France: Compliance with ANSM Guidelines

Regulatory Authority

National Agency for the Safety of Medicines and Health Product – France (ANSM)

The National Agency for the Safety of Medicines and Health Products in France is responsible for ensuring the safety of health products throughout their life cycle. It works with health professionals and their representatives to promote access to innovative products and ensure their safety. The agency uses authorization procedures tailored to each stage of a drug’s life, evaluates products, and maintains a surveillance policy to ensure they are safe, effective, accessible, and properly used. It operates on a national, European, and global network of expertise and surveillance, adhering to ethics and transparency principles.

Link for Regulatory Authority

https://ansm.sante.fr/

Local Regulation

French law articles L.5211-4 and R.5211-66

Classification

Class I, IIa, IIb and III

Listing or Registration Requirements

CE+Class IIa, llb, III: notification to agency

• All medical devices must bear the CE marking to be marketed in France.
  In the case of a non-European Manufacturer, an Authorised Representative or Representative must be appointed.
• For Class I MDs, sterile, measuring function, custom-made devices, kits, systems, sterilisation of devices and accessories, the Manufacturer or the Authorized Representative must send a statement to the Regulatory Authority enclosing the required documentation.
• For Class IIa, IIb, III and AIMDs (Active Implantable Medical Devices), the Manufacturer or the Authorized Representative must send a notification to the Regulatory Authority by submitting the required documentation before marketing the device.

Documents Required

• A copy of the instruction manual in French,
• A copy of the device labelling.

Registration Timeline

2 to 4 weeks

Registration Fee

No direct Registration Fee

License Validity

CE marking: 5 years ;France registration: Unlimited

Special Labelling Requirements

Labelling should be in French language.

Additional Comments

Medical devices having same intended use (same commercial name, the same EC declaration of conformity and the instruction for use) are subject to only one communication. The communication must be made at the time of the putting the medical device into service (article 1 of the MDD 93/42/EEC) onto the French territory.

Market Overview

The Medical Devices market in France is anticipated to achieve a revenue of US$17.89 billion in 2024. Cardiology Devices represent the largest segment, with a projected market volume of US$2.54 billion in the same year. The market is poised to exhibit an annual growth rate (CAGR 2024-2028) of 3.56%, leading to a market volume of US$20.58 billion by 2028. In a global context, the United States is expected to generate the highest revenue, reaching US$182.00 billion in 2024.

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk