a TÜV Rheinland company
Last 22 March 2023 entered into force on new royal decree of Medical devices with some new demands to implement in our companies.
Some of its main novelties are, among other:
- Requirements demanded for the product reprocessing single use only.
- Creation of a Trade Registration for all manufacturing companies, importers or distributors.
- For all dealers, communication of health product stores in all those communities where they are located.
- New requirements for full subcontractors of the manufacturing process. The AEMPS will demand for said companies their own activity license.
From Burotec, We can advise you on all the new aspects to implement in your companies to always work according to these new demands..
