Medical instruments

Export from United States of America

The United States is a developed country and has the world's largest national economy by nominal and real GDP, benefiting from an abundance of natural resources and high worker productivity. The US has the most technologically powerful economy in the world. The country is the second largest exporter of goods in the world.

The US has abundant natural resources, a well-developed infrastructure, and high productivity. The country produces approximately 18% of the world's manufacturing output, a share that has declined as other nations developed competitive manufacturing industries.

Chemical products are the leading manufacturing field. The United States is the largest producer of oil in the world, as well as its second largest importer. It is the world's number one producer of electrical and nuclear energy, as well as liquid natural gas, sulfur, phosphates, and salt. The National Mining Association provides data pertaining to coal and minerals that include beryllium, copper, lead, magnesium, zinc, titanium and others

Agriculture accounts for just under 1% of GDP, yet the United States is the world's top producer of corn and soybeans. The National Agricultural Statistics Service maintains agricultural statistics for products that include peanuts, oats, rye, wheat, rice, cotton, corn, barley, hay, sunflowers, and oilseeds. In addition, the United States Department of Agriculture (USDA) provides livestock statistics regarding beef, poultry, pork, and dairy products. The country is the primary developer and grower of genetically modified food, representing half of the world's biotech crops

The United States' exports account only for 13 percent of GDP. Main US exports are capital goods and industrial supplies. Other exports of USA include consumer goods, automotive vehicles, parts and engines, foods, feeds and beverages, chemical products, aircraft, spacecraft, medical, technical equipment, gems, precious metals, plastics, pharmaceuticals, organic chemicals.

Main exports partners of USA are Canada, Mexico, China, Japan, Germany and the United Kingdom.

Import to United States of America

The United States economy is primarily a free market economy but it is characterized as a "mixed economy" since there is some government involvement. The government intervenes in a free market economy when the perceived benefits of a government policy outweigh the costs. Markets are generally allowed to operate without undue interference from the government. 

Imported oil accounts for nearly 55% of US consumption and oil has a major impact on the overall health of the economy. Crude oil prices doubled between 2001 and 2006, the year home prices peaked; higher gasoline prices ate into consumers' budgets and many individuals fell behind in their mortgage payments. 

The United States is the world's second biggest importer. Main US imports are capital goods and consumer goods. Other imports of USA include industrial supplies, vehicles, gems, electronics, machines, electronics, medical and technical equipment, furniture, lighting, plastics.

Main import partners of the United States are China, Canada, Mexico, Japan and Germany. 

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Medical device designers, hospitals, surgery centers, surgeons and patients alike rely on Export Portal  and its variety of medical instruments in the operating room and procedure center each day to safely peoples life. Original equipment manufacturers, including the world’s largest medical device and healthcare companies, turn to Export Portal as the trusted eCmmerce platform for disposable torque instruments and implant fixation kits in the cardiac rhythm management, cardiovascular, neuromodulation, orthopaedic, spine, trauma, extremity, sports medicine and cranio-maxillofacial markets.  

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Customs requirements of United States of America

U.S. Customs and Border Protection 

Website: http://www.cbp.gov/ 

Address: 1300 Pennsylvania Ave. NW, Washington, DC 20229

Telephone: 202-325-8000

The United States of America (USA) is a federal republic composed of 50 states, situated between Canada and Mexico, with the state of Alaska in the northwestern and the state of Hawaii comprising an archipelago in the mid-Pacific. The territories are scattered about the Pacific Ocean and the Caribbean Sea. The USA is a member of the North Atlantic Treaty Organization, United Nations and other international organizations. 

Tariffs

USA tariffs are not unusually high by world standards. The US Customs Service and a number of government agencies regulate goods imported to the USA. Non-compliance may result in delays, extra costs, litigation and even prohibition.

The rate of duty customs assesses on a particular commodity imported is not binding for future shipments of the same or similar merchandise. USA customs has a binding ruling programme whereby importers can request a written ruling as to the proper classification and applicable rates of duty.

Customs brokers are licensed by the US Department of the Treasury and assess tariff classification, quota compliance and anticipation of difficulties in the entry of products you export to the USA. 

Tariff classification

All goods that enter the USA are categorised according to the Harmonised Tariff Schedule. Classification determines how much duty will be collected. It is a complicated process requiring the application of the General Rules of Interpretation: the section, chapter and subheading and explanatory notes. The importer is responsible for properly classifying merchandise before entry.

If you are unsure how to properly classify an item, a request for a binding rule can be made to US Customs. The rulings will be binding at all ports of entry unless revoked by the Headquarters' Office of Regulations and Rulings. The Customs Service will not issue binding rulings in response to oral requests. Oral inquiries may be made to customs offices regarding existing binding rulings that might cover your importation.

Non-tariff barriers

The US Food and Drug Administration (FDA) regulations covering food (human and animals) exports to the USA have changed. Food exporters that do not comply with the Bioterrorism Act regulations will have their goods refused entry.

The US Food and Drug Administration (FDA) has information relating to the following categories they monitor/regulate:

• food
• drugs
• medical devices
• radiation emitting products
• vaccines, blood and biologics
• animal and veterinary
• cosmetics
• tobacco products

The Consumer Product Safety Improvement Act (CPSIA) provided the Consumer Product Safety Commission (CPSC) with significant new regulatory and enforcement tools as part of amending and enhancing of several CPSC statutes. The CPSIA included provisions addressing:

• lead
• phthalates
• toy safety
• durable infant or toddler products
• third-party testing and certification
• tracking labels, imports and ATVs
• civil and criminal penalties

The CPSIA defines the term ‘children’s product’ and generally requires that products:

• comply with all applicable children’s product safety rules
• be tested for compliance by a CPSC accepted accredited laboratory, unless subject to an exception
• have a written Children’s Product Certificate that provides evidence of compliance
• have permanent tracking information affixed to the product and its packaging where possible

The CPSIA also requires domestic manufacturers or importers of non-children’s products to issue a General Certificate of Conformity (GCC). These GCC’s apply to products subject to a consumer product safety rule or any similar CPSC rule, ban, standard or regulation enforced by the Commission.

The CPSIA lists special requirements in Section 104 for certain durable infant and toddler products, including cribs.

Product liability

The US vendor might require product liability insurance and adequate coverage should be acquired in order to protect yourself. Before automatically seeking product liability insurance, try to evaluate the amount of risk and what level of insurance, if any, is necessary. For example, if you sell 10 to 15 pieces of highend jewellery each year through a few boutique retailers, you may decide that product liability insurance is not a necessary investment.

Import restrictions

The Customs and Border Protection (CBP) has been entrusted with enforcing hundreds of laws for 40 other government agencies, such as the U.S. Fish and Wildlife Service, the U.S. Department of Agriculture and the Centers for Disease Control and Prevention. These agencies require that unsafe items are not allowed to enter the United States. CBP officers are always at ports of entry and assume the responsibility of protecting America from all threats.

Restricted means that special licenses or permits are required from a federal agency before the item is allowed to enter the United States, these include:

• firearms
• certain fruits and vegetables
• animal products, animal by products and some animals

Quota Enforcement and Administration

Import quotas control the amount or volume of various commodities that can be imported into the United States during a specified period of time. Quotas are established by legislation, Presidential Proclamations or Executive Orders. Quotas are announced in specific legislation or may be provided for in the Harmonized Tariff Schedule of the United States (HTSUS).

Product certification, labelling and packaging

The Federal Trade Commission, the Food and Drug Administration (FDA) and the Department of Agriculture (USDA) all have guidelines that must be met depending on the product.

All imported products are inspected by US Customs to ensure that appropriate packing and labelling requirements are met.

Goods subject to different rates of duties should be packed separately unless they can be easily identified and separately both physically and on the import documents.

Packages containing mixed goods may otherwise be assessed for total duty at the highest rate applicable to any of the contents.

Strict regulations govern both the distribution in commerce and labelling of any packaged consumer commodity, including the manner of specifying and indicating net contents.

Food items must list all ingredients in order from most to least prevalent and must list nutritional information.

FDA does not have a pre-market approval system for cosmetic products or ingredients, with the important exception of colour additives and cosmetics and products and ingredients.

FDA maintains the Voluntary Cosmetic Registration Program (VCRP) for cosmetic establishments and formulations. This program is voluntary, but it is highly recommended.

Textiles and apparel must list country of origin, fibre content and fabric care instructions. The US Federal Trade Commission has produced a guide to help companies comply with federal labelling requirements for textiles and wool products. Threading Your Way Through the Labeling Requirements Under the Textile and Wool Acts.

Apparel items are subject to labelling and flammability requirements and articles containing fur or wool have additional labelling requirements.

Labeling for foodstuffs and pharmaceuticals should be submitted to the US Food and Drug Administration for approval, before shipments are made.

US customs laws require each imported article produced abroad to be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article permits, with the English name of the country of origin, to indicate to the ultimate purchaser in the USA the name of the country in which the article was manufactured or produced. Articles which are otherwise specifically exempted form individual marking are an exemption to this rule.

Documentary requirements

The US Customs authorities are very precise about import documentation being provided completely and accurately. Any error can cause major problems, risking delays or seizure of goods. The services of a competent customs broker is therefore strongly recommended.

Documentation requirements can be extensive and may include commercial invoice, certificate of origin, bill of lading, packaging list and special certificates.

The US Customs Department suggests that to speed customs clearance, the import community and the Customs Service have created the Customs Automated Commercial System (ACS) (http://www.cbp.gov/trade/acs), which electronically receives and processes entry documentation and provides cargo disposition information. Cargo carriers, customs brokers and importers may use the system, which reduces clearance time from day to hours or even minutes. Persons entering into the importing trade who intend to file their own entry documentation with customs are encouraged to explore this method of transacting business.

The US Customs Service suggests the following approach for faster customs clearance:

Include all information required on your customs invoice.

Prepare your invoices carefully. Make sure that your invoices contain the information that would be shown on a well-prepared packing list. Type them clearly and allow sufficient spaces between lines. Keep the data within each column.

Mark and number each package so that it can be identified with the corresponding marks and numbers appearing on your invoice.

Show a detailed description on your invoice of each item of merchandise contained in each individual package.

Mark your goods legibly and conspicuously with the country of origin unless they are specifically exempted from marking requirements as is required by the marking laws.

Comply with provisions of any special laws of that may apply to your goods.

Observe the instructions sent to you by your customer in the USA with respect to invoicing, packaging, marking, labeling, etc.

Establish sound security procedures at your facility and while transporting your goods for shipment.

Consider shipping on a carrier participating in the Automated Manifest System.

If you use a licensed customs broker for your transaction, consider using a firm that participates in the Automated Broker InterfacPro-forma invoice.

Public health requirements

The US Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) and the Animal Health division of APHIS regulates the importation of animal and animal-derived materials.

All meat and meat products must be processed in establishments approved by customs and must be covered by an appropriate certificate.

Imported livestock, including cattle, swine, horses and sheep and goat - as well as semen or embryos from these species - must be accompanied by a health certificate issued by an official of the exporting country. Similar requirements apply to poultry - including chickens, geese, ducks, pigeons and a number of other species.

Generally, a USDA veterinary permit is needed for materials derived from animals or exposed to animal source materials, including:

• animal tissues
• blood
• cells or cell lines of livestock or poultry origin
• RNA/DNA extracts
• hormones
• enzymes
• monoclonal antibodies for IN VIVO uses in non-human species
• certain polyclonal antibodies
• antisera
• bulk shipments of test kit reagents
• microorganisms including bacteria, viruses, protozoa and fungi

Health certificates indicating inspection and treatment are required for bees, live or dead, related products and beekeeping equipment.

Plants and plant products (including fruit and vegetables) are strictly controlled. Some are prohibited and others require permits from the USDA. Imports of these items must be covered by an appropriate certificate issued by the approved authority in the country of origin. In addition to possible inspection and disinfection, fruit and vegetables may be required to undergo prescribed treatments for fruit flies or other harmful insects as a condition of entry or to meet other special conditions.

Importation of milk and dairy products is subject to stringent regulations requiring import permits, licences and adherence to quotas and must comply with requirements of the USDA and APHIS. Livestock disease prevention requirements are necessary in addition to the requirements of the FDA.

Foods, cosmetics and pharmaceuticals are subject to regulations governing standards, composition, use of colouring matters, labelling, printing and claims of efficacy.

Federal law requires all packaged foodstuffs to list ingredients on the label. Information concerning the nutrition value of the contents is also required.

Sources:

https://www.cbp.gov/sites/default/files/documents/Importing%20into%20the%20U.S.pdf 

http://www.cbp.gov/trade/basic-import-export/importer-exporter-tips 

http://www.cbp.gov/trade/basic-import-export/export-docs/export-licenses