DeviCE Sistemas

International approval

International approval

International medical device markets

In addition to the CE marking, which is the mark by which the manufacturer of a product indicates that it complies with all the applicable requirements established in European Community legislation.

Despite the similarities, each country has its own specific regulations for medical devices.

The various international medical device markets have their own regulatory agencies that set the legal requirements for quality assurance and product safety. Thus, the USA has the FDA, Food and Drugs Administration, Saudi Arabia SFDA, China NMPA, Canada with HC, Japan with PMDA, Australia with TGA or New Zealand with Medsafe among many others.

deviCE Sistemas provides its clients with the possibility of accessing these markets and commercialising their products in compliance with the legal requirements demanded in each area. The international network of which deviCE Sistemas is a part allows the homologation of products in the different markets.

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