Do I need to register FDA approved products in Puerto Rico and U.S. Virgin Islands? the FDA approval integrates these countries ?
Any medical device or drug marketed in the US, including Puerto Rico and U.S. Virgin Islands, is subject to US FDA authority.
We have products which is not FDA approved but only EC marked.
As noted above, the CE Mark is not relevant to FDA.
What can I do to register them in these countries (Puerto Rico and U.S. Virgin Islands) ?
In general:
The marketer/manufacturer and, if relevant, the initial importer must Register annually. It's important to understand the relevant definitions (Specification Provider, Manufacturer, Contract Manufacturer, Component Maker, Initial Importer, Distributor, Private Label Manufacturing, etc.) which differ somewhat from those applicable in the EC.
The marketer/manufacturer will be subject to FDA inspection, and will be required in some cases, depending on product nature, to conform to certain FDA regulations governing design, manufacturing and marketing.
Prior to commencement of marketing, in many cases pre-market clearance must be gotten from FDA. The 510(k) process is one type of clearance.
Prior to commencement of marketing, the marketer/manufacturer must List their products.
The marketer/manufacturer and the initial importer have legal obligations in regard to post-market surveillance and timely reporting of adverse events.
This is just a brief overview. It's essential that the full scope of regulations be understood and applied as relevant.