2019-10-10
A new round of tariffs on U.S. imports from China took effect September 1, and China announced its own round of tariffs on U.S.-made goods would also take effect Sept 1. The Sept. 1 tariffs imposed by the United States were originally set at 10%, and they were later increased to 15% after China’s announcement.
While the U.S. list contains just a few healthcare products (e.g., surgical drapes and medical gloves) and seems to be dominated by food and clothing items, it does include raw materials such as several forms of aluminum, iron, stainless steel, and others, raising the question as to the impact on medical device manufacturing. We are not sure of that impact, so we invite you to tell us anonymously in our survey here. (We hope to share survey results anonymously in a future story.)
Pat Shafer, managing director of Grant Thornton’s healthcare and life sciences practice, told MD+DI back in August that the U.S.’s Sept. 1 tariffs were expected to have “a relatively small impact, in terms of a percentage of overall cost of manufacturing.” He said that the impact also depends upon whether U.S. medical device manufacturers are in fact sourcing such raw materials from China.
When asked about China’s news that it would levy its own tariffs on U.S. goods, Shafer said that “Chinese retaliation would be understandable—but after the G7 turn of events, it’s unclear what the future holds.”
Shafer said most of the impact from tariffs has already been felt as a result of the first round levied on Chinese goods. A number of finished medical devices originally on this list were later exempted, but that list still does include potential subassemblies used by medical device manufacturers, he said. He urged companies to check to see whether an exemption may apply. This docket lists exclusions that have been granted and denied across several industries. (MD+DI has reached out to the USTR to ask whether medical device manufacturers can still apply for exemptions for their finished medical devices imported from China and whether medical device manufacturers can apply for exemptions for raw materials imported from China to manufacture their finished medical devices in the United States.)
Meanwhile, rather than react to each new tariff announcement, medical device manufacturers instead should develop a long-term supply-chain strategy, Shafer advised. “Strategic long-term planning is needed to protect products, even the profitability of products,” he said. “The September 1 tariffs are a hiccup, with a relatively minor effect on margins. Instead, companies need to think in broader terms to mitigate future supply-chain risks and develop a long-term strategy.”
As an example, Shafer points to past work helping companies create what he calls “resilient supply chains.”
“I started several years ago helping pharmaceutical companies with blockbuster drugs come up with business continuity plans," he said. "These plans included dual-sourcing all materials, especially those from suppliers in countries with political risk; creating dashboards that monitor the risks presented by each supplier; and monitoring suppliers for their own risk management programs, such as whether they keep all their own supplies in just one building.”
Nonetheless, Shafer acknowledged that “tariffs are a big deal” and can impact manufacturing. He pointed to a separate round of tariffs that did not materialize. “We just got back from Juárez–El Paso, where goods come into Mexico and go through value-added processes and are shipped back to the United States. The free-trade zone in Juárez–El Paso contributes to the success of this region. Tariffs [on Mexico goods] were ultimately discarded, but I have to think that people are nervous about what might happen next.”
The impact of the tariffs, ingeneral, will be a topic of discussion during AdvaMed’s MedTech Conference held in Boston, September 23-25. Ralph Ives, AdvaMed’s executive VP of global strategy and analysis, said the device advocacy group has taken the position that tariffs could have a negative impact on the industry.
“AdvaMed is engaged with USTR regarding the U.S.-China trade talks,” Ives told MD+DI via email. “We will continue to work with officials in Washington and Beijing to make sure our views are known. AdvaMed strongly opposes tariffs by both sides on medical technology products that help save and improve millions of lives every day. We remain hopeful for asuccessful conclusion of the negotiations, which are delicate and with broad-reaching implications that our industry is watching closely on behalf of the patients we serve."
来源：LMDDI
20世纪60年代初，韩国政府着手建设本国的工业基础。到20世纪末，韩国已能生产普外科器械、通用医疗器械产品、诊断设备、牙科器械及卫生材料等常用医疗器械产品。但当时，韩国市场上95%的高端诊断成像仪和植入式医疗器械等高端医疗器械产品仍需从欧美、日本进口。
为扭转高端医疗器械产品依赖进口的局面，韩国产业通商资源部会同其他机构于2014年制定了《发展韩国医疗器械高端制造业8年规划》。经过几年努力，这一规划开始取得初步成效。2018年，韩国的体外诊断产品（以下简称IVD）中进口产品所占比重已从之前的90%以上降至65%。同时，韩国本国医疗器械产品开始崭露头角，心血管及心脏植入型器械产品（如起搏器、血管支架和人工瓣膜等）已在本国市场投入临床应用。此外，韩国的普外科器械产品大量出口到非洲及东南亚。
据报道，2018年韩国医疗器械市场规模在55亿美元~58亿美元之间，在亚洲医疗器械市场上排名第四。来自欧美及日本的进口产品在韩国医疗器械市场中约占35亿美元的市场份额（其中，美国产品约占一半），而韩国本土生产的医疗器械产品只占40%的市场份额。这表明，韩国在中高端医疗器械产品市场上仍对国外产品有一定依赖，但与20年前相比，韩国本土医疗器械产品占国内市场的比重已显著提升。
为进一步推动本国医疗器械产业的发展，韩国政府食品药品安全部门于2018年初公布了医疗器械产品监管的新法规，对原有医疗器械管理法规进行了修改，具体修改内容包括：采用事先特批的“先进医疗器械设备许可证”制度；建立“特殊性能医疗器械产品许可证”制度；简化IVD性能测试数据、质量控制测试结果等重要数据的管理体系；推广“线上分发”医疗器械产品及配送质量控制等措施；利用人工智能技术构建韩国医疗器械安全管理中心，评估产品的临床有效性；建立医用机器人许可证制度，检查系统性能，批准审查指南等相关配套措施等。
同年，韩国国会正式通过了新版《医药/医疗器械生产KGMP规范》（韩国良好生产规范），新规范的修改内容主要包括以下几方面：
第一，仿照欧盟及美国的做法，韩国政府药品及医疗器械监管执法部门将对本国及外国在韩生产企业实施 “飞行巡查”，以检查企业是否遵照KGMP的相关规定进行生产。
第二，改进审批方法，简化企业申请程序，提高工作效率。
第三，在学习西方国家先进监管经验的基础上，扩大有资质的“第三方审查”备选机构的名单。
第四，新版KGMP将进一步与ISO13485：2016《医疗器械 质量管理体系 用于法规
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