New Agency for Medical Device Registration in France
On April 29th 2012, France published in its official journal about the creation of a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), aimed to replace entirely its current regulatory agency, Afssaps, within a few months.
The MSNA will cover the mission, the rights and obligations of the former agency, while having a bigger operating budget, 157 million euro in 2012 compared to 125 million in 2010.
The new agency has a mission to increase resources for monitoring and the evaluationof health products more specifically to:
- Encourage the development of independent research focused on product safety,
- Conduct follow-up studies, collecting data effectiveness and tolerance,
- Conduct clinical trials against placebo and against active comparators by industry and get on their part, the provision of information likely to influence the evaluation of a product,
- Register and keep track of medical devices that want to be distributed and sold on the French territory.
ClassIIa, IIb, III medical devices and active implantable medical devices falling under the respective scopes of the EC Directives MDD 93/42/EEC and AIMDD 90/385/EEC will need to provide evidence of conformity with these directives in their technical documentations and have the CE marking affixed to them as such. Manufacturers of such devices will also require completing a Device Registration in France towards the French authorities in order for them to penetrate the French market.
As such, manufacturers outside the European Union are obliged to designate an Authorized Representative which shall be able to complete such registrations on their behalf and act as their official centralized vigilance contact point towards the MSNA and other EU member states competent authorities.