外媒看中国：2016中国医械行业将发生什么
2016/1/15 弗锐达医疗器械资讯

     得益于中国经济的高速发展，近年来中国的医药产业也成为了世界各大医药公司关注的中心。而作为这个市场中重要组成部分之一的医疗器械市场更是成为了众人眼中一块大蛋糕。几乎所有人都认为中国的医疗器械市场正在快速成熟，而与之配套的，中国相关部门在该领域的管理制度也在迅速完善。这些都有利于国内外的医疗器械公司共同发掘这一巨大市场。

     如今，2016年即将到来，如果有跨国企业想要进入中国医疗器械市场，他们要先做些什么？最近，Sidley Austin的合伙人Scott Bass就做出了如下预测。

     一、中国将推动医疗器械本土化进程

     Bass表示，2016年中国政府相关管理部门可能做出的最重要变化就是鼓励医疗器械研发、生产的本土化，特别是X射线设备等大型设备或将成为扶持的重点.一方面，本土化将降低生产医疗器械设备的成本；另一方面，这也表明中国将不满足于仅仅为世界医疗器械产业提供零部件，而是希望培育自己的医疗器械品牌，参与竞争。Bass还建议，跨国医疗器械公司进入中国市场的最好选择就是联手中国本土企业建立合资公司，通过本土化的方法参与中国市场竞争。

     二、“仅用于研究用途”漏洞不再

     众所周知，研究用设备与临床用设备有很大不同。后者需要经过相关管理部门的严格审批才能最终进入市场。然而，“研发使用”这一原本用于帮助基础研究的政策被许多公司视作漏洞，许多医疗器械公司以“仅限研发使用”的名义将尚未获得审批通过的产品(特别是体外检测设备)进行推广。而未来CFDA将会堵上这一漏洞，以进一步规范医疗器械的审批。这在Bass看来是一个巨大进步。

     三、对进口翻新产品说不

     中国政府管理部门将会明令禁止大型翻新设备的进口，理由是担心本国的进口商会将这些二手产品在当地销售。这些设备可能会对临床患者带来不可预测的风险。

     四、本地产品本地投标

     一直以来，中国政府都在努力降低居民的医疗成本。而昂贵的医疗器械尤其是植入物等产品则是被监控的重点对象。为了妥善处理这一问题，一般医院都会采取投标的方法进行采购。而未来为了进一步降低成本，政府或将鼓励医院使用本地产品。

     五、更多监管

     Bass还表示，近年来中国的GMP认证系统已经取得很大成就，其在医疗器械管理方面的一些做法已经走到了世界前列。而中国政府在加强本国监管的同时，还同意引入FDA的参与，积极鼓励本土医疗器械公司走出国门参与竞争。

     此外，Bass还提醒有意向进军中国的相关公司密切关注政府颁布的海外反腐败法等法规。

     以下为网站原文：

     What 2016 Might Bring for Chinese Medical Device Regulation

     Posted in China by mthibault on December 7, 2015

     Thinking of entering the Chinese medical device market in 2016? A life sciences regulatory expert details trends you need to know, like localization and increased inspection.

     Marie Thibault

     The Chinese medical device market is maturing rapidly, and with it, so is its regulatory presence. Scott Bass, partner at Sidley Austin, knows this firsthand. The law firm has worked with the Shanghai Institute for Food and Drug Safety in China on device regulation. Bass has lectured at Peking University on Good Manufacturing Practices (GMP) and with the US FDA has trained 100 inspectors on GMP for both drug and device inspection.

     Bass, who is based in New York and Washington, D.C. and heads the firm's Global Life Sciences team, works closely with colleagues Chen Yang and Lei Li, both partners in Sidley Austin's Beijing office.

     In a recent interview with MD+DI, Bass discussed the top trends on the horizon for the medical device market in China. Underlying many of these shifts is a move toward localization. For companies looking to enter the Chinese medical device industry, Bass suggests, "Take a good look at localization, because that is the trend for international companies . . . that is the way to enter with the greatest grace and success." One way to achieve this might be to work with a Chinese company through a joint venture.

     Here are Bass's thoughts, excerpted from the interview:

     Shift Toward Localization to Encourage China's Home-Grown Device Industry

     "China is encouraging local R&D and local manufacturing, particularly on what they call high-value medical equipment, which is particularly large medical equipment like X-ray machines and the like. They're focusing on that because of money in part, and in part because they want to localize all healthcare business—meaning drugs, devices—because that's part of their long-term goal. Not just to be a supplier of components in the device world, but to be a manufacturer of major medical devices."

     Research Use Only Loophole Closing

     "They've made a step forward to close the Research Use Only loophole . . . In Europe and America, there is a exemption under the device regs for Research Use Only devices . . . companies send a lot of devices out to be tested, new software, you mention it, under Research Use Only. That means what it says—it can be sent to institutions to test and use but it's only for research, not for commercial use. It's not for sale and it's not for marketing, but it is obviously a way the companies expose major centers to new devices or revised devices before they get approval. It can extend to rather expensive stuff. China recently closed the loophole on that. A lot of companies in China had been avoiding CFDA registration. Particularly with IVDs (in vitro diagnostics). A lot of hospitals, for example, were using unapproved IVDs and diagnostics because it takes a long time to get them registered in China. Now, the government has closed that up . . . That's a very important development."

     Imported Refurbished Products Will Be a No-No

     "China is moving to ban the importation of refurbished large equipment because that gives the possibility to local players to sell secondhand equipment that is refurbished locally. That's a part of the localization trend."

     Local Bidding for Local Products

     "There is a big push in drugs and devices, particularly in high-value medical consumables, like implants, to encourage the use of local products in hospital bidding. As you may know, in most provinces, most of the expensive device stuff is done through hospital bidding . . . it's a very elaborate system, very complicated and elaborate. So the government has been trying to keep prices down by going toward local products."

     More Inspection on the Way

     "I would say as a 10,000 foot observation—and I said this recently in the drug area—for years, China's had this very sophisticated GMP system in place. In some ways, their device regulations are some of the most advanced in the world, like their MDR reporting and the idea of a mass event, that doesn't exist anywhere else in the world . . . but the enforcement, until recently, has been much more episodic. Now, I think the Chinese feel that their companies are able to play more on the world stage, so they are actually ramping up enforcement of GMPs, allowing FDA in . . . there's going to be increased U.S. inspection of exporting companies in China . . . That's a big change and something that's of great significance. So companies here [in the United States] that buy components in China, there'll be increased inspection."

     For medical device manufacturers setting up offices and facilities in China, Bass also urges them to pay close attention to the Foreign Corrupt Practices Act and active anti-trust enforcement in the country.

     来源：医疗人咖啡

     本文为转载，版权属原作者所有。

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