In a move that has sent shockwaves through the Indian medical device industry, former U.S. President Donald Trump has imposed a

这一举动使得印度医疗器械行业震惊不已，美国前总统唐纳德·特朗普实施了

26% reciprocal tariff

26%的互惠关税

on medical device exports from India. This decision, aimed at correcting perceived trade imbalances and promoting domestic manufacturing in the U.S., has sparked concerns over its impact on Indian manufacturers, trade relations, and global supply chains.

对印度的医疗设备出口征收关税。此举旨在纠正所谓的贸易不平衡并促进美国国内制造业，但引发了人们对印度制造商、贸易关系以及全球供应链受影响的担忧。

India has long been a key supplier of

印度长期以来一直是关键的供应国

cost-effective, high-quality medical devices

成本效益高、高质量的医疗设备

to the U.S., particularly in the

到美国，尤其是在

low-value, high-volume consumables

低价值、高容量的消耗品

segment. However, with this new tariff, the competitiveness of Indian exporters could take a significant hit.

然而，随着这一新关税的实施，印度出口商的竞争力可能会受到重大打击。

Understanding the New Tariff Structure

理解新的关税结构

The

The

26% tariff

26%的关税

is part of a broader trade policy targeting medical device imports into the U.S. from multiple nations. Below is a comparative analysis of tariffs imposed on medical device exports from different countries:

是针对从多国进口到美国的医疗器械的更广泛贸易政策的一部分。以下是针对不同国家医疗器械出口征收的关税的比较分析：

Country

国家

Tariff on Medical Device Exports to the U.S.

对美医疗器械出口关税

India

印度

26%

26%

China

中国

34%

34%

Europe

欧洲

20%

20%

Vietnam

越南

46%

46%

Taiwan

台湾

32%

32%

Japan

日本

24%

24%

South Korea

韩国

25%

25%

Switzerland

瑞士

31%

31%

Indonesia

印度尼西亚

32%

32%

Malaysia

马来西亚

24%

24%

Turkey

土耳其

10%

10%

While India enjoys an

虽然印度享有

8% tariff advantage over China

对中国有8%的关税优势

, this might not be sufficient to offset the challenges posed by

，这可能不足以抵消所带来的挑战

non-tariff barriers

非关税壁垒

such as stringent regulatory approvals.

诸如严格的监管审批。

Impact on India’s Medical Device Exports

对印度医疗器械出口的影响

India’s medical device industry

印度的医疗设备行业

relies heavily on exports to the U.S.

严重依赖对美国的出口。

. In

。在

FY 2023-24

财政年度 2023-24

, India exported

，印度出口了

$714.38 million

7.1438亿美元

worth of medical devices to the U.S., whereas imports from the U.S. to India were significantly higher, at

对美国的医疗设备出口额，而从美国到印度的进口额则要高得多，达到

$1,519.94 million

1519.94百万美元

, according to data from the Export Promotion Council of Medical Devices.

根据医疗器械出口促进委员会的数据。

Key Concerns for Indian Exporters

印度出口商的主要关切

Loss of Market Share

市场份额丧失

The

The

26% tariff increases costs for Indian manufacturers

26%的关税增加了印度制造商的成本

, making their products

，使他们的产品

less competitive

竞争力较弱

in the U.S. market.

在美国市场。

Alternative sourcing

替代采购

from countries like

来自像这样的国家

Mexico, Puerto Rico, and Ireland

墨西哥、波多黎各和爱尔兰

(which have stronger trade agreements with the U.S.) may become more viable.

（与美国有更强贸易协定的国家）可能会变得更加可行。

Rise in Manufacturing Costs

制造成本上升

Many Indian manufacturers operate on

许多印度制造商运营于

low margins

低利润率

. A 26% price hike may

. 价格上涨26%可能

reduce demand

减少需求

and

和

impact profitability

影响盈利能力

.

。

U.S. buyers may

美国买家可能

switch to domestic alternatives

切换到国内替代品

or

或

diversify their supply chains

使供应链多样化

.

。

Impact on Foreign Direct Investment (FDI)

对外直接投资（FDI）的影响

The tariff may

关税可能

discourage foreign investors

打击外国投资者

from setting up production facilities in India for exports to the U.S.

从在印度设立生产设施以出口到美国。

Instead, investments may flow into

相反，投资可能会流入

Mexico, Ireland, and Southeast Asian nations

墨西哥、爱尔兰和东南亚国家

with more favorable trade policies.

伴随着更有利的贸易政策。

Regulatory Hurdles

监管障碍

Non-tariff barriers

非关税壁垒

, such as the

，比如

stringent U.S. FDA approval process

严格的美国FDA审批流程

, remain a bigger challenge than tariffs themselves.

，仍然是比关税本身更大的挑战。

The

The

FDA approval process

FDA审批流程

costs anywhere between

成本在任何地方之间

$9,280 to over $540,000

9,280美元到超过540,000美元

, adding a

，添加一个

significant financial burden

显著的经济负担

on Indian exporters.

对印度出口商。

AiMeD’s Views: A Call for Fair Trade Practices

人工智能观点：呼吁公平贸易实践

The

The

Association of Indian Medical Device Industry (AiMeD)

印度医疗器械行业协会 (AiMeD)

, a key industry body, has strongly opposed the discriminatory pricing mechanisms that put Indian manufacturers at a disadvantage.

，一个关键的行业机构，强烈反对使印度制造商处于不利地位的歧视性定价机制。

AiMeD’s Key Points:

AiMeD的关键点：

Discriminatory Pricing Mechanism is Unacceptable

歧视性定价机制是不可接受的

“AiMeD is opposed to any discriminating price compensation mechanism on basis of Regulatory Approval,” stated

“ AiMeD 反对基于监管批准的任何歧视性价格补偿机制，”声明称。

Rajiv Nath

里希·纳特

, Forum Coordinator, AiMeD.

，论坛协调员，AiMeD。

AiMeD

爱医德

criticized the preference given to foreign manufacturers

批评了给予外国制造商的优惠待遇

with U.S. FDA approvals, arguing that

获得美国FDA批准，认为

Indian firms should not be required to meet overseas regulatory criteria

印度公司不应被要求满足海外监管标准。

to operate domestically.

在国内运营。

Demand for Incentives for Domestic Manufacturers

对国内制造商的激励需求

AiMeD has suggested a

AiMeD 建议了一个

3-5% price preference

3-5%的价格优惠

to encourage

鼓励

value-added, high-quality manufacturing

高附加值、高质量的制造业

in India.

在印度。

This incentive should be based on

这个激励措施应该基于

objective quality certifications

客观质量认证

such as:

例如：

QCI’s Indian Certification for Medical Devices (ICMED)

QCI的印度医疗器械认证（ICMED）

ICMED Plus for ISO Compliance

ICMED Plus 用于 ISO 合规性

ISI Certification for BIS Standards

ISI认证符合BIS标准

Protecting the “Make in India” Vision

保护“印度制造”愿景

The high U.S. tariffs could

美国的高关税可能

boost American manufacturers

提升美国制造商

while

while

reducing India’s market share

减少印度的市场份额

, making India’s medical device industry vulnerable.

，使印度的医疗设备行业变得脆弱。

If India fails to counterbalance this with

如果印度未能用以下方式来平衡这一点

domestic policy changes

国内政策变化

, the

，这个

“Make in India” initiative could suffer setbacks

“印度制造”倡议可能遭遇挫折

.

。

Bilateral Negotiations Needed

需要进行双边谈判

AiMeD has

爱医学拥有

urged the Indian government to negotiate a balanced trade policy

敦促印度政府谈判达成一项平衡的贸易政策

with the U.S.

与美国

The organization suggests that India should

该组织建议印度应该

review its import duties on U.S. medical devices

审查其对美国医疗设备的进口关税

, which currently stand at

，目前处于

0% to 7.5%

0% 至 7.5%

, and consider implementing

，并考虑实施

reciprocal tariffs

互惠关税

to ensure fairness.

确保公平。

Opportunities Amidst the Crisis

危机中的机遇

Despite the challenges,

尽管面临挑战，

there are some potential opportunities

有一些潜在的机会

for Indian manufacturers in the short to medium term:

短期内对印度制造商而言：

U.S. Market Realignment Will Take Time

美国市场重新调整需要时间

Low-risk, high-volume consumables

低风险、高容量的消耗品

(e.g., syringes, catheters, gloves)

（例如，注射器、导管、手套）

are not manufactured at scale in the U.S.

在美国没有大规模生产。

Since the U.S. moved production of such items to

自从美国将此类物品的生产转移到

Mexico, Ireland, and Puerto Rico

墨西哥、爱尔兰和波多黎各

, bringing manufacturing back

，将制造业带回

could take 3-5 years

可能需要3到5年的时间

.

。

India could benefit in the short term

印度可能在短期内受益。

if it capitalizes on this gap.

如果它能利用这一差距。

Strategic Shift Towards Non-U.S. Markets

战略性转向非美国市场

Indian manufacturers could

印度制造商可以

diversify exports

出口多元化

to Europe, the Middle East, and Southeast Asia to

前往欧洲、中东和东南亚

reduce dependency on the U.S.

减少对美国的依赖

Strengthening Domestic Manufacturing for Self-Reliance

加强国内制造业以实现自力更生

The Indian government could

印度政府可能

introduce tariff adjustments

引入关税调整

on imported medical devices from the U.S.

来自美国的进口医疗设备上

Strengthening

强化

domestic manufacturing incentives

国内制造业激励措施

could

可以

reduce dependency on foreign products

减少对外国产品的依赖

and support India’s

支持印度的

healthcare security goals

医疗安全目标

.

。

The

The

26% tariff on Indian medical devices

印度医疗设备面临26%的关税

imposed by the U.S. is a major challenge that could impact the sector’s growth, profitability, and export competitiveness. However, industry leaders emphasize that

美国强加的措施是一个重大挑战，可能影响该行业的增长、盈利能力和出口竞争力。然而，业界领袖强调，

non-tariff barriers

非关税壁垒

remain a bigger issue than tariffs alone.

依然是比单独的关税更大的问题。

What Needs to be Done?

需要做什么？

Bilateral Negotiations

双边谈判

– India must push for fair trade policies.

- 印度必须推动公平的贸易政策。

Reciprocal Tariff Strategy

互惠关税策略

– Consider raising tariffs on U.S. imports.

- 考虑提高对美国进口商品的关税。

Encouraging Domestic Manufacturing

鼓励国内制造业发展

– Introduce incentives for local production.

- 引入对本地生产的激励措施。

Market Diversification

市场多元化

– Reduce over-reliance on U.S. exports.

– 减少对美国出口的过度依赖。

Strategic Policy Reforms

战略性政策改革

– Focus on regulatory simplifications and industry support.

- 专注于监管简化和行业支持。

The

The

global medical device industry

全球医疗器械行业

thrives on cooperative trade, and ensuring

通过合作贸易繁荣，并确保

a balanced approach to tariffs and regulations

对关税和法规的平衡方法

is

是

crucial for sustaining India’s growth in this sector

对维持印度在该领域的增长至关重要

. The

。这个

Indian government’s response

印度政府的回应

in the coming weeks will determine

在未来几周内将决定

whether Indian manufacturers remain competitive or face a steep decline in their U.S. market share

印度制造商在美国市场保持竞争力还是面临市场份额的急剧下降

.

。