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.
French law articles L.5211-4 and R.5211-66
Class I, IIa, IIb and III
CE+Class IIa, llb, III: notification to agency
2 to 4 weeks
No direct Registration Fee
CE marking: 5 years ;France registration: Unlimited
Labelling should be in French language.
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.
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.
Before placing a medical device into the market.
Contact us for free consultation: info@omcmedical.co.uk
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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