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阅读:6638回复:13

医疗器械出口美国FDA那点事

楼主#
更多 发布于:2013-05-14 16:33

医疗器械作为一个严森的行业,各国进口要求严格。 据我经验,进口美国基本都需要FDA认证,而且要求严格,对这个制度不了解的朋友,进口没那么容易。 大家一起一学习吧。

 

    FDA对医疗器械有明确和严格的定义,其定义如下:“所谓医疗器械是指符合以下条件之仪器、装置、工具、机械、器具、插入管、体外试剂及其它相关物品,包括组件、零件或附件:明确列于National Formulary或the Unite States Pharmacopeia或前述两者的附录中者;预期使用于动物或人类疾病,或其它身体状况之诊断,或用于疾病之治愈、减缓与治疗者;预期影响动物或人体身体功能或结构,但不经由新陈代谢来达到其主要目的者”。

只有符合以上定义的产品方被看作医疗器械,在此定义下,不仅医院内各种仪器与工具,即使连消费者可在一般商店购买之眼镜框、眼镜片、牙刷与按摩器健身器材等都属于FDA之管理范围。它与国内对医疗器械的认定稍有不同。

 

根据风险等级的不同,FDA将医疗器械分为三类(Ⅰ,Ⅱ,Ⅲ),Ⅲ类风险等级最高。FDA将每一种医疗器械都明确规定其产品分类和管理要求,目前FDA医疗器械产品目录中共有1,700多种。任何一种医疗器械想要进入美国市场,必须首先弄清申请上市产品分类和管理要求。

 

FDA针对医疗器械制订了许多法案,并不时地进行修改和补充,但根本的法案并不多,主要包括:联邦食品、药品与化妆品法案(FD&C Act,根本法案);公众健康服务法案;公正包装和标识法案;健康和安全辐射控制法案;安全医疗器械法案;现代化法案。对这些法案,FDA给予了非常详细的解释,并配套有具体的操作要求。企业在计划进入美国市场前,需仔细评估针对自己产品相关的法规和具体要求(包括不同的美国产品标准要求)。

  在明确了以上信息后,企业就可以着手准备有关的申报资料,并按一定程序向FDA申报以获取批准认可。对于任何产品,企业都需进行企业注册(Registration)和产品列名(Listing)。对Ⅰ类产品(占47%左右),实行的是一般控制(General Control),产品注册、列名和实施GMP规范,产品即可进入美国市场(其中极少数产品连GMP也豁免,极少数保留产品则需向FDA递交510(K)申请即PMN (Premarket Notification));对Ⅱ类产品(占46%左右),实行的是特殊控制(Special Control),企业在进行注册和列名后,还需实施GMP和递交510(K)申请(极少产品是510(K)豁免);对Ⅲ类产品(占7%左右),实施的是上市前许可,企业在进行注册和列名后,须实施GMP并向FDA递交PMA(Premarket Application)申请(部分Ⅲ类产品还是PMN)。

欢迎企业来咨询交流  FDA注册,产品注册,510K,QSR GMP体系建立! 189 22746089

参考资料:

If you are not registered with U.S. FDA

Registrar Corp's team of Medical Device Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:

  • Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with U.S. FDA and make changes, updates and cancellations as needed at no extra cost.
  • Assistance determining if U.S. FDA Medical Device User Fees are required for your registration and, if so, help prepare and submit your payment per U.S. FDA's requirements.
  • Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information.
FDA MEDICAL DEVICE REGISTER AND LISTING

美国(美国)使用医疗器械的生产和分配涉及营业场所(也称为机构或设施业主或经营者必须每年向FDA注册这个过程被称为设立登记

美国国会已授权FDA收集每年设立设备建立注册登记费所有这些建立类型,必须缴纳登记费一个详细清单可以发现必须注册,列表和支付费用没有减少每年设立登记为小型企业或任何其他

登记费如下财年时间表

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations. A detailed list of all those establishment types that have to pay the registration fee can be found at "Who Must Register, List and Pay the Fee". There are no reductions in annual establishment registration fees for small businesses or any other group

The schedule of registration fees for fiscal years as follows:

Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number (510(k), PMA, PDP, HDE).

Who Must Register, List and Pay the Fee

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.

The following charts detail the requirements for registration and listing based on the type of activity performed at that establishment. The chart also includes a column showing which types of activities require payment of the establishment registration fee. See the Fee page for additional details.

  • Domestic establishments
  • Foreign establishments
  • Definitions of establishment types
  • 必须注册,列表和支付费用
  • 用于商业分布美国(美国)医疗器械的生产和分配涉及机构必须每年向FDA注册需要注册机构也需要列出的设备活动建立这些设备进行

    以下图表详细的要求,根据活动的类型建立执行登记和上市图表还包括一列显示哪些类型的活动需要支付,设立登记费页面看到更多细节

    国内机构

    外国机构

    建立类型定义

Domestic establishments

Activity Register List Pay Fee
Manufacturer YES
807.20(a)
YES
807.20(a)
YES
Manufactures a custom device YES
807.20(a)(2)
YES
807.20(a)(2)
YES
Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user YES
807.20(a)(5)
 
YES
807.20(a)(5)
YES
Manufacturer of components that are distributed only to a finished device manufacturer NO
807.65(a)
NO NO
U.S. Manufacturer of export only devices YES
807.20(a)(2)
YES
807.20(a)(2)
YES
Relabeler or Repackager YES
807.20(a)(3)
YES
807.20(a)(3)
NO
Contract manufacturer who commercially distributes the device for the specifications developer YES
807.20(a)(2),
YES
807.20(a)(2),
YES
Contract manufacturer who does NOT commercially distribute the device for the specifications developer NO NO NO
Contract manufacturer of subassembly or component, Contract Packager or Labeler NO NO NO
Contract sterilizer who commercially distributes the device YES
807.20(a)(2),
 
YES
807.20(a)(2),
 
YES
Contract sterilizer who does NOT commercially distribute the device NO NO NO
Kit Assembler YES
807.20(a)
YES
807.20(a)
YES
Domestic Distributor NO
807.20(c)(3)
NO NO
Specification Developer YES
807.20(a)(1)
 
YES
807.20(a)(1)
YES
Specification Consultant Only NO
 
NO NO
Initial Distributor/Importer YES
807.40(a)
NO
Enforcement Discretion Used for 807.22(c)
NO
Device being investigated under IDE NO NO
807.40(c)
NO
Reprocessor of single use devices YES
807.20
YES
807.20
YES
Remanufacturer YES YES NO
Maintains complaint files as required under 21 CFR 820.198
(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)
YES YES YES

Foreign Establishments

Activity
Register
List
Pay Fee
Foreign Manufacturers YES
807.40(a)
YES
807.40(a)
YES
Foreign Exporter of devices located in a foreign country YES
807.40 (a)
YES
807.40 (a)
NO
Contract Manufacturer whose device is shipped to U.S. by the contract manufacturer. YES
807.40(a)
YES
807.40(a)
YES
Contract Sterilizer whose sterilized device is shipped to U.S. by the sterilizer. YES
807.40(a)
YES
807.40(a)
YES
Reprocessor of Single-use Device YES
807.20(a)
YES
807.20(a)
YES
Custom Device Manufacturers YES
807.20(a)(2)
YES
807.20(a)(2)
YES
Relabeler or Repackager YES
807.20(a)(3)
YES
807.20(a)(3)
NO
Kit Assembler YES
807.20(a)
YES
807.20(a)
YES
Device Being Investigated under IDE NO
812.1 (a)
NO
812.1(a),
807.40(c)
NO
Specification Developer YES YES YES
Remanufacturer YES YES NO
Manufacturer of components that are distributed only to a finished device manufacturer NO
807.65(a)
NO NO
Maintains complaint files as required under 21 CFR 820.198
(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)
YES YES YES

Definitions of Establishment Activities

Contract Manufacturer - Manufactures a finished device to another establishment's specifications.

Contract Sterilizer - Provides a sterilization service for another establishment's devices.

Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.

Initial Distributor - Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.

Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).

Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

Remanufacturer - Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.

Reprocessor of Single Use Devices – Performs remanufacturing operations on a single use device.

Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

U. S. manufacturer of export only devices – Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.

1条评分, 铜币 +15
  • 华南商家运营-肖肖
    铜币 +15
    感谢急救箱朋友的分享,很不错! 另外,807.40是注册费用还是什么呢?如果能再根据实际情况,解答得更清楚就更好哈! 欢迎更多分享!
    2013-05-14 17:07
喜欢10 评分1
生产 防水箱 工具箱 塑料箱 医药箱 急救绷带 紧急救护产品
肖肖
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沙发#
发布于:2013-05-14 17:07
感谢急救箱朋友的分享,很不错! 另外,807.40是注册费用还是什么呢?如果能再根据实际情况,解答得更清楚就更好哈! 欢迎更多分享!
开心工作,认真生活!
回复(0) 喜欢(0)     评分
saferlife
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板凳#
发布于:2013-05-14 18:11
内容里提的 这些807.20(a)  807.40(a) 812.1(a),  都是FDA药典法 CFR 里面的章节 ,比如说章节820就是对医疗器械质量体系的要求
生产 防水箱 工具箱 塑料箱 医药箱 急救绷带 紧急救护产品
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cn1001894947
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地板#
发布于:2013-07-18 10:14
非常好的分享!很及时。

最近联系上一美国买家,对我们的产品很感兴趣,可惜我们没有FDA认证。
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cnherbest
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地下室#
发布于:2013-07-18 11:30
学习了
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cn1001429311
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下水道#
发布于:2013-07-18 11:31
好贴,学习了!
本性做人,角色做事,特色定位!
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cn1501256358
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地下城市#
发布于:2013-07-18 11:47
可以建一个FDA证书讨论群么?
需要高手指导一下!
每一个你讨厌的现在都有一个不够努力的曾经! 今天多努力,明天更如意!
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地核#
发布于:2013-07-18 11:48
非常仔细的介绍。另外FDA需要在美国有公司或是找代理商代办。然后每年需要交年费续费。
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cnosto
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地心#
发布于:2013-07-18 14:21
好复杂哦
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cn1001681283
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9重天#
发布于:2013-07-23 15:09
强烈建议版主弄一个FDA群啊。我也可以帮忙建
Hearing aid manufacturer
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cn1500352896
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10楼#
发布于:2013-07-31 13:34
增长见识,谢谢楼主。
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11楼#
发布于:2013-08-07 11:27
详细的介绍!
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cn1501602639
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12楼#
发布于:2013-08-07 11:30
FDA真让人头疼~
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cn1501602654
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13楼#
发布于:2013-08-07 11:33
太有用了
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