Prolinx offer you as an EU authorised representative with following services:
Product Registration: We can register your product in EU for the first time and get your product a Certificate of Registration.
Renewal and Update Product Registration: The product Certificate of Registration is valid for one year only and must be renewed annually. The information about the product must be updated whenever it changes and at leastonce a year when renew the product Certificate of Registration.
Keep Your Technical Files: We store and update the Technical Files of your products sold in Europe, and makes them available timely to the appropriate surveillance/vigilance authorities upon request.
Legislation Monitoring: We monitor and report on new developments in European product legislation relevant to your products.
Vigilance and Incident Reporting: We assist with product vigilance and incident reporting.