According to the Royal Decree 192/2023 of medical devices and Royal Decree 1662/2000 of in vitro diagnostic medical devices, They will need a prior operating license granted by the Spanish Agency of Medicines and Health Products all manufacturers, Importers, Groupers, Sterilizers and reprocessors of medical devices and in vitro diagnostic medical devices, Your accessories, Appliances and instruments used in permanent make-up, semi-permanent or in the tattooing of the skin using invasive techniques, as well as non-medical devices listed in Annex XVI.
To obtain it, Companies must have:
- Requirements and procedures in place to ensure product quality controls.
- Facilities & Resources appropriate to your activities
- Availability by a Technical Manager with the appropriate qualification
- Have a Documentary archive to store the generated documentation
- Ensure the Compliance with requirements in the case of concerted activities
These licenses are valid for 5 years, so it is necessary to renew it before the Spanish Agency of Medicines and Health Products Once deadlines have been met. This involves overhauling the system, as well as facilities, to ensure compliance with current regulations that apply to you.
Burotec it can accompany them throughout the process of adapting their company to the requirements required by Royal Decree 192/2023, on medical devices and Royal Decree 1662/2000, on medical devices for in vitro diagnosis and in the necessary procedures before the Spanish Medicines Agency, until the relevant licences are obtained.
Request information about the PRIOR OPERATING LICENSE, COMMUNICATION OF DISTRIBUTION OR IMPORT LICENCE and the requirements to be met in your specific case by sending an e-mail to info@burotec.es or by calling to the +34 913768950.
Licence sanitary product