License Management
A legislative requirement that, after its approval, guarantees compliance with the requirements of any company in the medical device sector.
The application for a licence, or simple communication, are procedures required for all economic agents in the medical device sector.
The licence or communication, depending on the company’s activity in relation to the medical device, will be sent to the appropriate Administration , typically the Spanish Agency for Medicines and Medical Devices or the corresponding Autonomous Community depending on where the company is located.
Needs
The requirements vary in relation to the object of the licence or communication requested and, with it, the risk that the activity represents in relation to the medical device.
At PS Consulting we will be happy to help you in the management of this or other procedures related to the Competent Authorities.
Blog
