Shipping procedures

According to FDA regulations, the medical devices that emit radiations and that are imported into the United States must comply with applicable U.S. regulations before, during, and after import. Class I and Class II devices can be shipped from US to other countries without FDA permission, but it also involves certain limitations.

ADB Consulting’s shipping procedures fulfill all the requirements necessary for importing and exporting medical devices at both domestic and international levels. These requirements include registration of manufacturing facility, listing of products, manufacturing in accordance with the quality system regulation, reporting of adverse events, premarket notification or premarket approval if applicable.

All the devices can be shipped outside US only if they are:

·         meet the requirements and specifications of the foreign purchaser

·         in agreement with the laws of the country to which it is intended for export

·         labeled on the outside of the shipping package that they are intended for export; and

·         Not sold or up for sale in the United States.

We are aware of not only the regulatory guidelines imposed by the local authorities, but also well equipped with the knowledge of the laws of other countries. This is what gives us an edge over others.

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