COMPLIANCE requirements check import to the US

COMPLIANCE  requirements check for importers to the US
(Documented “Road Map” ) 

$1500
The U.S. and global regulations: certification & labeling . The US Customs brokerage services calculation, customs  import duties calculations for project planning from exporting from country of manufacturing to import, duty paid, unloaded at the US warehouse. Financial plan of the project.

Actual Implementation
from $5000
the US IMPORT COMPLIANCE 
 
FDA, USDA registration of foreign manufacturer, the importer to The U.S., certification & labeling 

We are your “GENERAL CONTRACTOR” for importation process and preparation for distribution within the US

The US Customs brokerage services calculation, customs  import process organization  for project realization

A full package of realization of your project from A to Z

option: EUROPEAN UNION, RUSSIA, CIS (ex USSR countries) 

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Compliance requirements check for importers to the US

We are humans. Everybody is eating food, visiting doctors to cure particular diseases. But no one wants to be poisoned by poor-quality food, get harm from dysfunctional medical devices, and receive email letters, advertising the services for curing asthma, data about which was leaked to the network due to an unprotected system inside the hospital, where you were at the doctor’s appointment. 

There’s only thing standing between this terror and people, which is protecting us - regulatory requirements, particularly USDA, FDA and HIPAA, which are being controlled at the level offers state and federal law. 

According to TechCrunch, agrifood industry is worth at least $8T with rapid growing yearly. If you own a company, which is selling the products, connected with healthy/organic food, fertilizers, cereal plants and wood, and you would like to import these wares to the US(no matter these are raw materials or finished products) - this isn’t possible without the approval of the USDA regarding the need of obtaining certain certificates or permits.   Especially if the enterprise is specializing in fertilizers, because they can carry a risk to the ecological system of the plants, and therefore they have very serious requirements, up to the names and infusions of each bacterium. 

During the pandemic period in 2020 every single country had a problem with the shortage of medical equipment. On April 1st Russia sent a plane with special ventilators for mechanical breathing to New York. However, none of the machines was used in local hospitals due to lack of Food and drug Administration(FDA) certification. Later it was returned back to Russia and now this accident is under the investigation. 

As far as you understand now, FDA regulatory compliance is the only way to legally bring your goods to the US/British/Australian market, if you would like to sell anything what is connected with food, drugs, medical devices, vaccines, cosmetics and tobacco products. 

In order to legally import these goods to the US market, firstly you need to count the production costs for each part of the project: logistics, delivery to the destination, warehouse rent, certificate fees, etc . Then after calculations, a list with the information about the products, facilities, warehouses, etc should be created in order to send it for FDA certificate registration. After that, if your product is made for human consumption, customs broker calls to the USDA department for you to fill “Application to permit”, where you need to provide additional requested data, according to importer’s particular products. There are lots of issues and it’s always better and easier for you to give regulation compliance to the specialists, like us. 

As far as we are living in the century of technologies and innovations - everything is on digital: your bank cards, photos and videos, phone numbers, your preferences, etc. But It isn’t a surprise, that large companies also use the capabilities of modern world to collect the data about their clients, patients, etc. In hospitals, medical institutions, laboratories, etc, to keep it encrypted and safely transmitted between the network, these products need to have a HIPAA certification. 

Based on the foregoing, without HIPAA requirements compliance, it is impossible to legally supply medical software. Companies hire auditors to check their team and equipment for the correspondence with regulations. Therefore, without legal certification, you and the company can have very serious legal consequences on the federal and state level.  For you to get rid of these problems, I’m happy to introduce my partner Gennadiy Daych, who has CIA, CRMA, CHIAP, MBA licenses and over 20 years of experience, who would be happy to help you! 

Some products need to be FDA & HIPAA compliant at the same time, which are connected with medical software in the cloud and an equipment. Life example, Apple Watch has a feature to control your pulse. For that to work Apple needed to receive HIPAA and FDA licenses. 

Summing up, if you would like to do serious business in the United States, you should consider the steps in advance and the first thing on the list should be the certification of the products. As you understand, without regulatory compliance, it’s impossible to be on the market legally and your goods will never appear on store shelves. We, as the professionals in this field with many years of experience, can help you with examination and adjustments to the requirements of your product’s particular sphere, as the whole good’s implementation and compliance to the regulations.