To market Medical Devices 93/42/EEC and the IVDs 98/79/EEC in Spain, in addition to the Directive requirements, the related Spanish transposition Law also previewed a National Registration Process.
The Process requires the collection and review of the main Technical Documents related to a specific device, and most importantly the Spanish Labelling. Additionally, some specific information is demanded concerning some commercial aspects, like the date of marketing in Spain.
All this data and those documents are then uploaded to the Official PMPS Electronical database, that also generate the TAX to be paid the Authorities in order to complete the Registration.
Thanks to Obelis’ great relationship with the Spanish Authorities, we were informed in advance that from the 4th of June 2018 there is a Brand-New database, created mostly to solve bugs and browser compatibility problems. With some probability also in the light of the new MDR and the related national process that may (or may not) generate.
The new Database is CCPS and Obelis has full access and credentials to guide you through the process and to register on your behalf. If you intent to market in Spain, please do not hesitate to Contact Us, and our National Registration Specialists will provide you with the best possible feedback.
Davide Turchi