SUBMISSION OF RALPH F. IVES
ON BEHALF OF
THE ADVANCED MEDICAL TECHNOLOGY ASSOCIATION
TO
THE COMMITTEE ON SECTION 301
JUNE 17, 2019
Introduction
About AdvaMed
The Advanced Medical Technology Association (AdvaMed), with headquarters in
Washington D.C., represents over 400 manufacturers of the full range of medical
technology – cardiovascular and orthopedic implants, in vitro diagnostics, surgical devices,
and diagnostic equipment. These technologies, protect, improve and save patients’ and care
providers’ lives around the world. While AdvaMed represents large well-known
manufacturers, about 75 percent of our members are America-based small and medium
size enterprises.
The U.S. medical device industry is spread throughout all 50 states, with 13,699 facilities.
We are directly responsible for over 500,000 high paying American jobs and an estimated
total of 2 million jobs (direct and indirect) − and generating over $150 billion annually in
direct economic output.
AdvaMed Request
AdvaMed shares the Administration’s opposition to Chinese policies that discriminate
against U.S. firms. We are also concerned that China could implement the goals of its
“Made in China: 2025” policy in a way that leads to additional or strengthened
discriminatory practices.
We very much appreciate that the U.S. Trade Representative (USTR) removed
approximately $2 billion of medical technology products from its proposed Section 301 list
on which an additional 25 percent tariff was imposed on July 6, 2018. We also appreciate
that the value of medical technology on the lists enacted on August 23, 2018 and
September 24, 2018 list were modest. However, over $836 million of medical technology
products remain on the July 6, 2018 list (Annex 1). In addition, component products that
are not identified as medical technology (e.g., circuit boards, disk drives, motor parts,) are
included in the USTR lists, which can increase the cost of manufacturing certain medical
products (Annex 4). Finally, despite the USTR’s welcomed exclusion for “select medical
1

 goods,” the value of products classified in the harmonized tariff schedule (HTS) as medical
devices on the proposed List 4 totals over $1.3 billion (Annex 3).
We ask that: (1) all increased tariffs on HTS codes for medical technology products (as listed in
Annex 1 and Annex 2) be removed; (2) no additional tariffs be imposed on the medical products
listed in in Annex 3, including HTS numbers: 3926.90.99.10; 3926.90.9990; 4015.19.05.50;
6307.90.60; 6307.90.68; and 6307.90.89.10; 8528.52.00.00; and 9027.90.20.00. In addition,
we ask that the impact of increasing tariffs on the component products listed in Annex 4 be
recognized and those tariffs not be increased, including 8517.62.0900.
We make this request for the following reasons:

•
•
•
•
•
•
•
•
•

U.S. trade retaliation and sanctions measures historically have not included medical
products due to humanitarian reasons;
the FRN clearly recognizes the sensitivity of medical goods by indicating the
exclusion of “select medical goods,” which your include all medical technologies;
the inadvertent impact would be inconsistent with the President’s objectives for
balanced trade and of targeting products included in “Made in China: 2025”;
a large share of the imports on the list are components and semi-finished products,
which are used by our manufacturers to make products in the United States that are
competitive in a global market;
our industry enjoys a nearly balanced trade relationship with China;
U.S. tariffs would leave the highly regulated medical technology industry
particularly vulnerable to Chinese nontariff measures;
the import tax has the potential to disrupt some patient access;
costs are difficult to shift because of multi-year contracts;
our industry did not participate in the Section 301 process and was not included in
the Report.

If tit-for-tat retaliation continues, the Administration’s objectives for a strong domestic
medical technology industry will be undermined. We ask the Administration to consider
this adverse impact and to remove all medical technology products from its retaliation lists.
We have provided USTR lists of key issues we have requested be included in the
negotiations – discriminatory and non-reciprocal measures by Chinese authorities. These
measures involve regulatory and payment policies, which if not corrected or even
exacerbated could increase the U.S. trade deficit with China.
The U.S. Medical Technology Industry
The medical technology industry is an American success story. Many of the medical
devices and diagnostics on the market today trace their origins to U.S. inventors. Over the
technology life cycle, the U.S. industry remains the leading creator of innovation in the
global market. This history of innovation ranges from mature, staples of healthcare that are
used in almost every patient interaction to rapidly developing advanced medical devices.
The average lifespan of a new medical device is about 18-24 months – e.g., an
2

 improvement in a pacemaker today is likely to be overtaken by another breakthrough by
2021.
The U.S. industry has been historically competitive globally, and we remain so. The U.S.
industry is one of the few manufacturing and technology industries that has consistently
maintained a trade surplus. U.S. exports of medical technology to the world totaled $52.5
billion in 2017, and imports were $51.4 billion – for a surplus of $1.1 billion.
But over time that surplus has diminished. In 2007, the United States exported $34.7
billion and imported $29.1 billion of medical devices – for a surplus of $5.5 billion. The
ratio of the surplus to total medical technology trade was nine percent in 2007 compared to
one percent in 2017 – indicating a decreasing relative surplus. This change is a result of
competitive pressures in other countries – as business people in other markets expand their
own medical technology industries – but also because of government measures that favor
local firms – e.g., “localization” preferences, including in China.
Impact of USTR’s Proposed Actions
USTR’s Proposed Actions
In its announcement of April 4, 2018, USTR proposed to impose additional 25 percent
tariffs on $50 billion of U.S. imports from China. We estimated that the imposition of an
additional 25 percent duties would have impacted at least $3 billion of medical devices and
diagnostics, and related components, entering the United States from China. While we
appreciated that about $2 billion were removed, we regret that any medical technology was
retained on the final list, as these products are used to treat patients. Also, including
medical products on the USTR list – with the exception of pharmaceuticals – encouraged
China to add medical technology to its lists.
The USTR list of May 17, 2019 includes up to $1.3 billion of medical devices on which a
25 percent tariff will be added. We oppose these additional tariffs on these products.
These products are largely used as consumables in the U.S. healthcare setting, and they
would likely result in added costs to the health care system – either manufacturers,
patients, providers, or insurers.
Adverse Impact on US Competitiveness
The U.S. medical technology industry is the most innovative and competitive in the world.
There are many reasons for this leadership – including our decades of advancement, the
high percent of revenue devoted to R&D, efficient supply-chain sourcing, and USG
support for leveling the playing field around the world. Another key factor is the industry’s
consistently strong espousal of open markets – in the United States and in other countries.
These factors combine to allow U.S. firms to manufacture the best medical technology for
patients in the most efficient way, to grow our industry in the United States, and to hire
more American workers.

3

 Rising healthcare costs around the world are putting pressure on governments to cut costs,
including in the United States. While we have evidence demonstrating that medical
technology can help alleviate cost pressures over time, downward pressures on prices
continue – including through the use of price controls in some countries – such as
maximum sales prices in Chinese provinces. The U.S. industry must be efficient to thrive.
Increasing our supply-chain costs through higher tariffs would exacerbate our
competitiveness problem – with China, Europe, Japan, and many others. AdvaMed
member companies source components and semi-finished products from all over the
world, including China, to complete the manufacturing process of medical technologies
here at home for domestic use or export. We cannot accurately calculate the final cost
impact of higher tariffs, as the initial tariff hike reverberates and escalates through the
various levels of the supply chain. That is, the tariff increase of 25 percent in the imported
component could end up being some multiple of that amount as it is used in intermediate
products for resale to the next level of processing and on to the final product.
Shifting the source of inputs for finished medical technologies also involves costs. FDA
has regulations affecting changes to input used in manufacturing medical technology.
Depending on the risk classification of the product and the use of the component being
changed, FDA may require a supplemental submission to the FDA. If this were to occur,
changes in sourcing could lead to delays of well over several months to 18 months , as this
would require identifying a suitable alternative, notifying FDA, inspecting and validating
the specific manufacturing process (e.g., installation, performance, operations), and
submitting supplemental registration data. Even if a company believes its product with a
new component would not need specific FDA approval, the firm would still be required to
use resources to validate that the component from the new source meets specifications,
which can also take several months. These stringent standards ensure safety and quality of
care but also add significant supply chain complexity and inflexibility with respect to
alternative manufacturing locations, let alone countries of origin.
The tariff increase acts as a tax on our members. The president and Congress again
suspended the 2.5 percent device tax on revenue earned from sales of medical technology
in the United States. The reason this suspension enjoyed overwhelming bipartisan support
was because there was clear recognition that this tax undermined U.S. competitiveness and
costs U.S. jobs. For some AdvaMed members, the effect of the tariff increases has more
than offset gains from suspension of the medical device tax. For those manufacturers,
future R&D spending is likely to be cut if the tariffs remain – adversely impacting U.S.
competitiveness to pioneer the next generation of life-saving diagnostics and therapies.
U.S. jobs would likely be lost, and in some instances, entire product supply options will be
limited.
Finally, if the USTR objective in its retaliation process were to try to avoid raising input
costs for U.S. industry and, instead, to focus on finished products coming from China, that
appears to be very difficult to do. We cannot accurately calculate the relative shares of
components versus finished medical technology imported from China. The HTS frequently
combines components and finished products, making it difficult to estimate the relative
value of each. Our members identified over 90 non-medical technology HTS codes for
4

 parts and components on the USTR list that are used in their medical technology products.
Our rough estimate is that over 60 percent of the medical technology products on USTR’s
list include components and semi-finished products used to manufacture finished products
in the United States. However, the actual figure could be different.
Inconsistent with USTR Objectives
The Administration’s broad objective for bilateral trade with China is to substantially
reduce the U.S. trade deficit. In addition, Ambassador Lighthizer has been clear that the
USTR retaliation list is intended to target products from those industries identified in the
“Made in China:2025” initiative. We recognize that high-end medical technology products
are included in China’s plan.
Increasing import tariffs on the medical technology products on the USTR lists is not
consistent with reducing the trade deficit in our industry. The United States enjoys a
roughly balanced trade with China for medical devices and diagnostics. This reciprocal
trade relationship in our industry should mean that including these products on the lists is
contrary to the Administration’s trade deficit objective – i.e., if a trade deficit requires
corrective measures, no action should be necessary when trade is balanced.
USTR action could undercut our sales in China. Our members have enjoyed a vibrant
growth of trade with China, which imports about 70 percent of its total use of medical
technology. China’s consumption of medical technology quadrupled during the past
decade. U.S. medical technology exports to China have grown every year and exceeded
$4.7 billion in 2017; imports from China were about $5 billion. The Chinese industry has
also grown rapidly during this period. U.S. firms still have a substantial advantage over
Chinese companies when it comes to R&D, manufacturing, and export of high-value
medical technology. Chinese patients also strongly prefer foreign brands.
In addition, USTR action could adversely affect U.S. medical technology companies’
participation in China’s plan to vastly improve healthcare. There are significant
opportunities for U.S. medical technology under “Healthy China 2030,” which lays out
several ambitious public health goals in addition to addressing major demographic shifts
and increases in the incidence of non-communicable diseases. This plan is somewhat at
odds with “Made in China: 2025,” in that China will continue to rely heavily on foreign
medical technology in the years ahead to meet growing demand and achieve these public
health goals. We need the USG to contribute to making the U.S. industry more
competitive, not less, so that our industry can contribute to fulfilling this critical healthcare
need and expand U.S. sales in China.
It is also not possible for USTR to accurately target “Made in China: 2025” products
because of the limitations of the HTS. The antiquated HTS codes cannot differentiate
among the many categories of medical technology products. The HTS was developed in
the 1980s − before most medical technology on the market today was invented. The
World Health Organization reports that there are over 22,000 generic groups of medical
technologies and 2 million types of products. The HTS has only about 120 lines for
medical devices and diagnostics, which is clearly inadequate to target types of products.
5

 In addition, the USTR list does not, and cannot, distinguish between the “new” types of
medical technology China has specifically targeted in “Made in China: 2025” from the
products that have been on the market for years. China has identified “new” high-end
medical technology,” including:
•
•
•
•

medical imaging equipment including MRI, CT, PET-CT, integrated PET-MRI and
other new imaging equipment;
clinical laboratory equipment including molecular diagnostic equipment, automated
microbial detection systems, high resolution optical imaging systems;
advanced treatment equipment such as image-guided radiotherapy equipment, highdefinition electronic endoscopes, high-definition confocal endomicroscopy; and
rehabilitation and medical monitoring devices (including wearable devices).

We estimate that the majority of medical technology products on the USTR lists are not
even the categories identified by the Chinese for “Made in China: 2025.” The USTR
algorithm seems to be aggregating a wide range of the medical technology HTS codes and
assuming they are included in the “Made in China: 2025” plan.
U.S. medical technology investment in China is important for our competitiveness with
China and globally. Despite the challenges we identified, our members have invested in
China, as they have in other countries. The reasons for overseas investments vary but are
usually aimed at providing patient access to medical devices and diagnostics in the most
timely and affordable means possible, as well as to remain competitive. Achieving these
objectives often means that our members’ investments need to be located close to patients
and supply chains. For example, most U.S. medical technology firms’ investments in
China are done to supply the Chinese and surrounding markets. Some of that investment is
also to manufacture components for medical technology products, including those finished
in the United States. A few members ship finished products from China to the United
States to respond to demand, which comes primarily from U.S. hospitals that could
otherwise not afford the more expensive equipment.
s
While our members have experienced a vibrant commercial relationship with China, we
recognize the competitive threat from China. Analysis by the International Trade
Commission shows that the medical technology industry in China (represented by both
Chinese and foreign companies) appears to be moving up the value chain. This increase
includes: (1) capital equipment, such as advanced medical imaging equipment (e.g.,
computed tomography (Cat Scans) and magnetic resonance imaging ; (2) implantable
devices such as cardiac pacemakers and orthopedic implants; (3) non-implantable devices,
such as ventilators, infusion pumps, surgical supplies, and diagnostic test kits. Of course,
all products entering the U.S. market must have FDA approval and from facilities that
must be subjected to FDA inspections.
We provide this analysis because we want USG officials to understand that we are not
underestimating the competitiveness of the Chinese industry or the potential threat from
the power and resources of the Chinese government. We have voiced our concerns about
Chinese policies, including about “Made in China: 2025,” which sets the goals of
6

 increasing the use of domestic high-end medical devices in county hospitals to 70% by
2025, and the percentage of domestic content in core components by up to 80% by 2025.
While “Made in China: 2025” was highlighted in the Section 301 Report, there was no
mention of the specific measures China might use to meet these broad goals for our
industry. Imposing higher tariffs on medical technology imports from China will not help
U.S. competitiveness or achieve the President’s objectives for our industry.
Inconsistent with Public Health
Including medical technology products on the USTR list is troubling from a public health
perspective. Healthcare products have been consistently recognized as being exempt from
trade sanctions – even with countries which the United States considers to be security
risks. For example, the Trade Sanctions Reform and Export Enhancement Act of 2000 and
all subsequent sanctions legislation, embargoes, and policy disputes with other countries to
date, have indicated that key humanitarian products, including medical devices, should be
excluded from such trade measures. The fundamental rationale is that patients should have
access to basic human necessities. Therefore, we believe medical technology should be
exempted from USTR’s Section 301 lists for humanitarian reasons alone.
We are also concerned that the import tax of medical technology could be disruptive to
patient access in some areas, especially if the tariff were to be imposed for a lengthy
period. When a 25 percent tax is introduced into a market, those costs have to be absorbed
somewhere − by the manufacturer, the distributor, the customer (hospital/lab) or the
patient. In the U.S. healthcare market – with payments for medical technology largely
coming indirectly from insurance companies, Medicare, and out-of-pocket patient
expenses – manufacturers have very limited ability to pass on cost increases. (That is,
hospitals purchase the medical technology from the manufacturers or distributors, and the
hospitals are reimbursed for procedures involving medical devices and diagnostics by
private parties or the government.)
While it is not possible for us to forecast the precise balance of these forces, a 25 percent
tax puts pressure on the system and could force the industry to cut costs to compensate in
areas such as R&D and jobs. Steadily declining Medicare reimbursement rates already are
causing razor-thin margins for some manufacturers; an additional tax makes it even more
difficult, if not completely untenable, to continue to supply these products. Absent an
ability to absorb these costs, there will pressures to reduce supplies.
AdvaMed Involvement in China
AdvaMed has been deeply engaged in China since 2005, when we began collaboration
with the Chinese Government on a variety of regulatory, ethical business practices, and
payment issues. We first hired a part-time employee in 2007. We now have an office in
Shanghai and a subsidiary in Beijing. We expect to expand to a staff of 7-8 by the end of
this year. Of course, some of our members have been selling medical devices and
diagnostics in China for several decades and have developed their own relationships with
Chinese officials and other stakeholders.
7

 During the period in which AdvaMed has been intensely engaged on Chinese policies, we
have experienced challenges, frustrations, failures and successes – with several of those
achievements coming under the Trump Administration. We will not catalogue these issues
in this testimony – as we have been fortunate to enjoy the support of USG agencies − such
as USTR, Commerce, State, Treasury, and the U.S. Embassy – and have documented these
areas over the years. We greatly appreciate this assistance and believe USG involvement
has been directly responsible for whatever successes we have experienced. However, we
remain concerned that USTR actions and Chinese reactions could undermine our mutual
progress for industry and patients alike.
Chinese Retaliation
China’s response to USTR tariff lists has been to impose tariffs on all of its imports of U.S.
medical technology – as best we can determine. However, because of the aggregate nature
of the HTS and lack of harmonization between the US and Chinese HTS codes, we cannot
verify the exact value of these U.S. exports to China. The impact, however, is not
insubstantial given the size and growth of the Chinese market for medical devices and the
fact that the United States is the leading supplier of medical devices to the China market.
Chinese patients will continue to have access to innovative medical technology, but from
other sources. The U.S. industry is the leading supplier to China -- accounting for over 30
percent of its medical device and diagnostic imports. China will look for countries outside
the United States – Europe, Japan, Southeast Asia – as alternative sources for U.S.
technologies. A series of tit-for-tat retaliatory tariffs that lasts a prolong period would
adversely impact our industry in the United States and their business with China.
The Chinese government has greater legal flexibility in imposing non-tariff barriers and
restrictions than does the USG. The Chinese regulatory authority must approve all foreign
medical devices and diagnostics for safety and effectiveness – just as USFDA does in the
United States. Central government officials can influence the timing of regulatory approval
decisions for U.S. medical devices, delaying market access. Likewise, public hospitals,
operated by some level of government authority (central, provincial, city) are responsible
for over 80 percent of healthcare delivery in China. These government authorities can
impose limitations on the amount of U.S. medical devices and diagnostics purchased.
In addition to these potential Chinese actions that could directly target U.S. medical
technology, the Chinese Government has additional tools to foster a hostile environment in
China. For example, Chinese authorities could launch investigations under its antimonopoly laws, its anti-corruption laws, or its new cybersecurity laws. Even if no violation
were found, the investigations themselves are chilling, costly and undermine U.S. business
confidence.

8

 Section 301 Investigation and Report
Investigation
AdvaMed and our members chose not to participate in the Section 301 investigation,
which was focused on intellectual property (IP) theft and forced technology transfers.
While these issues are of some concern to our members, they are not the primary obstacles
we face in accessing the Chinese market.
USTR Report
We applaud the lengthy and detailed Section 301 report USTR issued on March 22, 2018.
However, the medical technology industry is not cited in the 182-page document.
Alternative Approach
AdvaMed and our members do not endorse imposing import tariffs on medical technology
as a means of changing China’s behavior in our industry. Indeed, we believe that these
tariffs could undermine our efforts to obtain and maintain access to China’s market on a
mutually reciprocal basis, as well as impact our global competitiveness.
AdvaMed has laid out clear issues in the regulatory and payment areas that need to be
addressed by China for our industry to obtain access to the Chinese market comparable to
the access that the Chinese medical technology industry enjoys in the United States. For
example:
•
•
•
•
•
•

Clinical trial requirements imposed based on international best practices;
UDI system based on international standards;
End of country-of-origin requirements;
Continued postponement of national pricing system for medical technology;
Implementation of two-invoice systems only if appropriate for medical technology;
Central tendering systems that do not disadvantage U.S. firms.

If a final agreement is reached between U.S. and Chinese negotiators, we will be
evaluating its benefits on the basis of progress reached in these areas. We realize that
implementation must be secured, that additional progress must be made, that we need
strong USG support. We also recognize that strong enforcement provisions must be
included to discourage China from reverting to behavior that adversely affects our
industry.
Conclusion and Requests
Our industry will be less competitive if import tariffs remained on the products we
identified above. We respectfully request that increased tariffs on imports of the medical
technology products be removed and no additional tariffs be imposed.
9

 Annex 1
Medical Devices on $34 billion US List

8419.90.50.40
*8421.91.60
*9011.80.00

8419.90.50.40 - Parts Of Medical, Surgical or Laboratory Sterilize
8421.91.60 - Parts of centrifuges, including centrifugal dryers, nesoi
90118000 – Compound optical microscopes other than stereoscopic or those

for microphotography, microcinematography or microprojection
9018.11.30
9018.11.60
9018.11.90
9018.12
9018.13
9018.14
9018.19.40
9018.19.55
9018.19.75
9018.19.95

9018.20
9018.90.20
9018.90.30
9018.90.60
9018.90.75
9021.50
9022.12
9022.13
9022.14
9022.21
9022.30
9022.90.05
9022.90.15
9022.90.25
9022.90.40
9022.90.60
9022.90.95
*9027.50.40

9018.11.30 - Electrocardiographs
9018.11.60 - Printed Circuit Assemblies For Electrocardiographs
9018.11.90 - Parts and Accessories For Electrocardiographs,Neso
9018.12 - Ultrasonic Scanning Apparatus
9018.13 - Magnetic Resonance Imaging Apparatus
9018.14 - Scintigraphic Apparatus
9018.19.40 - Apparatus, Functional Exploratory Examination& Pts
9018.19.55 - Patient Monitoring Systems
9018.19.75 - Printd Circ Assemb For Parameter Acquisition Modul
Electro-diagnostic apparatus nesi, and parts and accessories thereof nesi
Ultraviolet or infrared ray apparatus used in medical, surgical, dental or veterinary
sciences, and parts and accessories thereof
9018.2 - Ultraviolet or Infrared Ray Apparatus, & Pts & Acc
9018.90.20 - Optical Instruments and Appliances and Parts,Nesoi
9018.90.30 - Anesthetic Instruments and Appliances and Parts
9018.90.60 - Electro-Surgical Instruments & Appliances & Parts
9018.90.75 - Dialysis Instruments and Apparatus
9021.5 - Pacemakers For Stimulating Heart Muscles
9022.12 - Computed Tomography Apparatus
9022.13 - Appts Base On X-Ray For Dental, Uses, Nesoi
9022.14 - Appts Base On X-Ray, Medical,Surgical,Vetnry,Nesoi
9022.21 - Appts Base On Alpha,Beta,Etc. Radiation,Medical,Etc.
9022.3 - X-Ray Tubes
9022.90.05 - Radiation Generator Units
9022.90.15 - Radiation Beam Delivery Units
9022.90.25 - High Tension Generators,Desks,Chair,Etc.
9022.90.40 - Parts and Accessories Of X-Ray Tubes
9022.90.60 - Pts Of Apparatus Based On The Use Of X-Rays
9022.90.95 - Pts,Use Alpha,Beta/Gamma Radiations, Etc., Nesoi
9027.50.40Electrical instruments and apparatus using optical radiations
(ultraviolet, visible, infrared), nesoi

10

 *9027.80.45
*9027.90.56
*9027.90.59
*9030.33.38

9027.80.45- Electrical instruments and apparatus for physical or chemical
analysis, measuring viscosity, checking heat, sound, light, etc, nesoi
9027.90.56 - Parts and accessories of electrical instruments and apparatus of
subheading 902720, 902730, 902750 or 902780
Other parts and accessories of other electrical instruments and apparatus of
heading 9027, nesoi
9030.33.38 Other instruments and apparatus, nesoi, for measuring or checking
electrical voltage, current, resistance or power, without a recording device

*Not previously included as medical device due to classification error

11

 Annex 2

List of Medical Devices on USTR’s $16 Billion Section 301 List
9025.19.80
9025.19.80.40 Clinical thermometer, nt combined w/oth inst,nesoi
9025.19.80.80 Thermometers, nt combined with oth inst
9029.20.40
9029.20.40.40 Speedometers & tachometers used in civil aircraft
9029.20.40.80 Speedometers, tachometers nt for civ aircrft nesoi
3919.90.50
3919.90.50.10 Self-adhesive reflectorized sheeting of plastics
3919.90.50.20 Filament reinforced tape, in rolls exceeding 20 cm
3919.90.50.12 Electrical tape, in rolls exceeding 20 cm wide
3919.90.50.30 Transparent tape, in rolls exceeding 20 cm wide
3919.90.50.60 Self-adhs plate,sheet,strip,etc of plastics,nesoi
3917.40.00
3917.40.00.10 Fittings for vehicle brake hoses
3917.40.00.90 Other fittings for tubes,pipes & hoses,of plastic
3920.10.00 Nonadhesive plates, sheets, film, foil and strip, noncellular, not reinforced
or
combined with other materials, of polymers of ethylene
9030.84.00 Instruments & apparatus with .recordng device nesoi
9030.89.01 Instruments & apparatus w/o recording device nesoi

12

 Annex 3
Medical Technology HTS Categories on USTR List 4

*3926.90.99.10
*3926.90.99.90
4015.19
6115.10
6307.90.60
*6307.90.68
6307.90.89
*8528.52.0000
9001.30
*9027.90.2000

Laboratory Ware
Plastic parts of medical devices
Gloves, Except surgical, Vulcan rubber, nesoi
Graduated compression hosiery
Perineal towels of fabric formed on base of paper
Surgical Drapes, Disp, Spunlaced/Bonded, Man-Made
Cotton Surgical Towels
Monitors for used in or with diagnostics and medical devices
Contact lenses
Microtomes

*Not previously included as medical device due to classification error

13

 Annex 4

List of Non-Medical Device Inputs for Manufacturing Medical Devices in the U.S.
38089410 – Disinfectants, containing any aromatic or modified aromatic disinfectant
40169915 - Caps, lids, seals, stoppers and other closures, of noncellular vulcanized rubber
other than hard rubber
73181600 - Iron or steel, nuts
73202050 - Iron or steel, helical springs (o/than suitable for motor vehicle suspension)
76061260 - Aluminum alloy, plates/sheets/strip, w/thick. o/0.2mm, rectangular (incl. sq), clad
76082000 - Aluminum alloy, tubes and pipes
84135000 - Reciprocating positive displacement pumps for liquids, not fitted with a measuring
device, nesi
84136000 - Rotary positive displacement pumps for liquids, not fitted with a measuring device,
nesi
84137020 - Centrifugal pumps for liquids, not fitted with a measuring device, nesi
84138100 - Pumps for liquids, not fitted with a measuring device, nesi
84139190 - Parts of pumps, nesi
84149090 - Parts of air or vacuum pumps and ventilating or recycling hoods
84186901 - Refrigerating or freezing equipment nes
84199050 - Parts of molten salt cooled acrylic acid reactors, nesi; parts of certain medical,
surgical or laboratory sterilizers, nes
84199095 - Parts of machinery, plant or laboratory equipment for the treatment of materials by
a process involving a change of temperature, nesoi
84213980 - Filtering or purifying machinery and apparatus for gases, other than intake air
filters for internal combustion engines or catalytic conv.
84239090 - Other parts of weighing machinery, including weights
84283900 – Continuous action elevators and conveyors, for goods or materials, nesi
84289002 - Machinery for lifting, handling, loading or unloading, nesi
84313900 - Parts suitable for use solely or principally with the machinery of heading 8428, nes
84433250 - Single function units other than printer units (machines which perform only one of
the functions of printing, copying or facsimile transmiss
84439925 - Parts and accessories of printers, neso
85361000 - Fuses, for a voltage not exceeding 1,000 V
14

 84602400 - Other grinding machines, numerically controlled
84661001 - Tool holders and self-opening dieheads for use solely or principally with machines
of headings 8456 to 8465, nesoi
84662010 - Work holders for machine tools used in cutting gears
84662080 - Work holders for machine tools other than those used in cutting gears, nesoi
84716080 - Optical scanners and magnetic ink recognition devices not entered with the rest of
a ADP system
84717040 - ADP magnetic disk drive storage units, disk dia. n/ov 21 cm,not in cabinet, w/o
attached external power supply, n/entered w/rest of a system
84717060 - ADP storage units other than magnetic disk, not in cabinetsfor placing on a table,
etc., not entered with the rest of a system
84717090 - ADP storage units other than magnetic disk drive units, nesoi, not entered with the
rest of a system
84779085 - Parts of machinery for working rubber or plastics or for the manufacture of
products from these materials, neso
84798200 - Machines for mixing, kneading, crushing, grinding, screening, sifting,
homogenizing, emulsifying or stirring, nesi
84799094 - Parts of machines and mechanical appliances having individual functions, not
specified or included elsewhere in chapter 84, neso
84807180 - Molds for rubber or plastics, injection or compression types, other than for shoe
machinery or for manufacture of semiconductor devices
84819090 - Parts of taps, cocks, valves and similar appliances for pipes, boiler shells, tanks,
vats or the like, nes
84821050 - Ball bearings other than ball bearings with integral shafts
84829965 - Parts of other ball or roller bearings, nesi
84839080 - Parts of transmission equipment, nesi
85011040 - Electric motors of an output of under 18.65 W, other than synchronous valued not
over $4 each
85013120 - DC motors nesi, of an output exceeding 37.5 W but not exceeding 74.6 W
85030075 - Parts of electric motors under 18.65 W, other than commutators, stators or rotors
85043200 - Electrical transformers other than liquid dielectric, having a power handling
capacity exceeding 1 kVA but not exceeding 16 kVA
85044040 - Electrical speed drive controllers for electric motors (static converters)
15

 85049041 - Parts of power supplies (other than printed circuit assemblies) for automatic data
processing machines or units thereof of heading 8471
85049065 - Printed circuit assemblies of the goods of subheading 8504.40 or 8504.50 for
telecommunication apparatus
85049075 - Printed circuit assemblies of electrical transformers, static converters and
inductors, nesoi
85049096 - Parts (other than printed circuit assemblies) of electrical transformers, static
converters and inductors
85065000 - Lithium primary cells and primary batteries
85059075 - Other electromagnets and parts thereof, and parts of related electromagnetic
articles nesi
8517.62.0900 – Machines for reception, conversion, and transmission or regeneration of voice
images or other data, nesoi 8517.62.0090
85238020 - Discs, tapes, solid state non volatile storage devices, "smart cards" and other media
for the recording of sound or of other phenomena, whet
85285933 - Color video monitors w/flat panel screen, video display diagonal > 34.29 cm, not
with VCR/player, not subj US note 13
85299022 - Other printed circuit assemblies suitable for use solely or principally with the
apparatus of headings 8525 to 8528, nesi
85299083 - Other parts of television apparatus (other than television cameras), nesi
85322300 - Ceramic dielectric fixed capacitors, single layer
85322900 - Fixed electrical capacitors, nesi
85334080 - Electrical variable resistors, other than wirewound, including rheostats and
Potentiometers
85361000 - Fuses, for a voltage not exceeding 1,000 V
85362000 - Automatic circuit breakers, for a voltage not exceeding 1,000 V
85364900 - Relays for switching, protecting or making connections to or in electrical circuits,
for a voltage exceeding 60 but not exceeding 1,000 V
85365090 - Switches nesoi, for switching or making connections to or in electrical circuits, for
a voltage not exceeding 1,000 V
85369040 - Electrical terminals, electrical splicers and electrical couplings, wafer probers, for
a voltage not exceeding 1,000 V

16

 85369085 - Other electrical apparatus nesi, for switching or making connections to or in
electrical circuits, for a voltage not exceeding 1,000 V, nesoi
85389060 - Molded parts nesi, suitable for use solely or principally with the apparatus of
heading 8535, 8536 or 8537
85389081 - Other parts nesi, suitable for use solely or principally with the apparatus of heading
8535, 8536 or 8537
85414020 - Light-emitting diodes (LED's)
85414070 - Photosensitive transistors
85414080 - Photosensitive semiconductor devices nesi, optical coupled isolators
85444990 - Insulated electric conductors nesi, not of copper, for a voltage not exceeding 1,000
V, not fitted with connectors
85447000 - Optical fiber cables made up of individually sheathed fibers
90029095 - Mounted optical elements, nesi; parts and accessories of mounted optical elements,
nesi
90132000 - Lasers, other than laser diodes
90138070 - Liquid crystal and other optical flat panel displays other than for articles of
heading 8528, nesoi
90258015 - Nonelectrical barometers, not combined with other instruments
90258040 - Thermographs, barographs, hygrographs and other recording instruments, other
than electrical
90258050 - Combinations of thermometers, barometers and similar temperature and
atmosphere measuring and recording instruments, nonelectrical
90262080 - Instruments and apparatus, other than electrical, for measuring or checking the
pressure of liquids or gases
90278025 - Nuclear magnetic resonance instruments
90278045 - Electrical instruments and apparatus for physical or chemical analysis, measuring
viscosity, checking heat, sound, light, etc., nesi
90279045 - Printed circuit assemblies for instruments and apparatus of subheading 9027.80
90279054 - Parts and accessories of electrophoresis instruments not incorporating an optical or
other measuring device
90279056 - Parts and accessories of electrical instruments and apparatus of subheading
9027.20, 9027.30, 9027.50 or 9027.80

17

 90308200 - Instruments and apparatus for measuring or checking electrical quantities, nesoi:
for measuring or checking semiconductor wafers or devices
90318080 - Measuring and checking instruments, appliances and machines, nes
90319091 - Parts and accessories of measuring or checking instruments, appliances and
machines, nesoi
90321000 - Automatic thermostats
90328960 - Automatic regulating or controlling instruments and apparatus, nesi

18