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您向美国出口药品和医疗器械吗 ?

请允许美国伟康有限公司 Wellkang LLC 为您提供全套,迅捷,简便,专业化, 高质量,价格优惠的服务!

FDA 对于药品和医疗器械登记和制造商注册的规定

从 2002 年2月11 日起, 所有外国生产的产品(人用药物、动物用药物、生物制品和医疗器械) 被进口或被提供为进口到美国,其生产制造商必须向美国食品和药物管理局FDA登记。所有外国厂 家必须指定一个美国代理商- US Agent。美国代理商必须在美国有经营场所,且必须身处美国。 美国代理商的目的是担当一条在国外设施和FDA之间的沟通渠道。


  1. 医疗设备制造商
  2. 人用药物制造商
  3. 动物用药物制造商
  4. 生物制品制造商

美国伟康有限公司为美国境外的药品、医疗器械制造商, 提供全套,迅捷,高质量,价格优惠的服务。 在协助您与美国FDA打交道的过程中,美国伟康有限公司为 您提供完整的FDA套餐服务:

  • 根据FDA要求,担当您的FDA注册的美国代理商- US Agent
  • 将您的工厂及设施在美国FDA登记注册备案,(使用表格 2891)
  • 回答FDA关于您产品的问题
  • 必要的话,协助安排FDA人员赴外国厂家实地审核
  • 当您的情况(比如,地址,电话等)变更时,对您已在FDA注册的资料及时修改和更新
  • 回复FDA关于您产品的问题
  • 据FDA规定,每年定期更新您的工厂及设施在美国FDA的注册信息,(使用表格 2891A)
  • 如果您的工厂设施关闭或不需再登记,取消您在FDA的注册
  • 向第三方确认您已在FDA注册备案 (如果您需要这项服务的话。)
  • 担当一条在国外设施和FDA之间的沟通渠道

美国伟康有限公司将代表您,递交注册表给食品和药物管理局, 并将为您的设施获得确认和注册号。使用美国伟康有限公司的服务,您将发现它不仅高效、 便捷、而且价格公道。除了作为您的美国代理商外,伟康还可以在 涉及美国食品和药物管理局FDA的其它与医疗器械相关的业务中为您服务, 包括: 510(k)档案建立, 进入市场预先申报 PMN 等等。 我们对药品与医疗器械生产厂家的FDA服务项目及收费,视产品而定。 请联系我们以便获得进一步信息。

FDA Requirements for Pharmaceutical Products & Medical Devices



Medical Devices are classified by Regulation, that is detail descriptions are contained within the Code of Federal Regulations (21 CFR 862 - 892), and various classifications and requirements listed for each device. There are three classes: class 1 are the lowest risk devices and class 3 are the highest risk devices.

The classification regulation will also state whether the device is subject to Good Manufacturing Practice (GMP) requirements: most class 1 devices are exempt and most class 2 or 3 devices are subject to them.

All Medical Devices have to be listed with FDA, in addition: most class 2 devices are subject to a Pre-Market Notification 510(k) procedure and most class 3 devices are subject to a Pre-Market Approval (PMA) Process.

Establishment Registration and Product Listing

The owner or operator of an establishment for the manufacture, preparation, propagation, compounding, assembly or processing of a Medical Device is required to register it with FDA. Each Medical Device must be listed with FDA.

U.S. Agent

Since February 11, 2002, ALL Foreign Establishments whose products (Human Drugs, Animal Drugs, Biological Products, and Devices) are imported or offered for import into the United States MUST be REGISTERED with the FDA and designated a United States Agent, i.e. a US Agent. The U.S. agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.

    The Foreign Establishment means any of the follows:
  1. Medical device manufacturers
  2. Human drug manufacturers
  3. Animal drug manufacturers
  4. Biological manufacturers

The agent will assist FDA in communications with the foreign establishment, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign establishment.

As your US agent, as defined and required by the FDA final rule, Wellkang LLC will:
  • Assist the FDA in communications with the foreign establishment.
  • Respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States.
  • Assist FDA in scheduling inspections of the foreign establishment.
  • If the FDA is unable to contact the foreign establishment directly or expeditiously, the agent will facilitate information or document exchange between the FDA and the foreign establishment.
  • The agent will file either the Initial Registration Device Establishment Form 2891 (if you have previously never registered with FDA) or file the Annual Registration of Device Establishment Form 2891(a).

As one establishment can only appoint one U.S. Agent it is not always desirable to appoint a distributor, for example, where the manufacturer uses more than one distributor.

Pre-Market Notification, frequently called 510(k)

This is a notification made under section 510(k) of the Federal Food , Drug and Cosmetic Act, FD+C Act, of the intention to manufacture a Medical Device. The notification is to demonstrate to FDA that the device is substantially equivalent to another that was on the market prior to May 28, 1976, or a device the has already been cleared through the 510(k) process. If FDA agrees, they will issue a determination of substantial equivalence.

There are many variations to this procedure that may be applicable to a particular situation, for example: third party review, special 510(k)'s (for changes to existing devices), abbreviated 510(k)'s (for products conforming to agreed standards). In certain circumstances some additional certifications are also required.

Pre-Market Approval (PMA)

This is a formal approval of the safety and effectiveness of a device by FDA based on valid scientific data and rational. A PMA is an order of magnitude more stringent than a 510(k) because it is an absolute, not merely a comparison, process

A PMA can be a traditional large submission at the end of the design process, or a Modular submission, where modules are submitted and reviewed at agreed project-milestones. A Product Development Protocol, PDP, is an extension of this concept, where a protocol for development is agreed in advance and data reviewed in realtime. Both these options can reduce the time spent waiting for an approval at the end of the project but require confidence that the development will proceed according to plan.


GMP- Good Manufacturing Practice (Quality System Regulation, QSR)

The Good Manufacturing Practice (GMP) regulations in 21 CFR 820 are based on ISO 9001 (pior to the inclusion of continuous improvement et al in ISO9000:2000) and usually refered to as the Quality System Regulation (QSR). There are however significant differences between the requirements and for a manufacturer selling into both US and EU markets it is essential to design a quality system that meets both.

FDA conduct inspections of manufacturers to assess compliance. FDA have a program of recognizing third parties to conduct these inspections on their behalf. Non-Compliances are legal infractions and consequently far more significant than any found during a Notified Body's or Registrar's Audit.

Medical Device Reports

There are specific legal requirements and time-frames for reporting to FDA instances of malfunction, harm or death involving devices, as well as "near-misses". It is important to assess all customer communications against the reporting criteria.

Changes and Re-Designs

Depending on the circumstances these can require: no formal submission to FDA (merely in-house documentation), a full or partial prospective resubmission or a retrospective submission. Compliance with the Design Control elements of the QSR is essential.


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出口欧洲?请务必访问: CE认证网  CE信息网
出口美国?请务必访问: FDA注册认证网  FDA美国代理网
中国市场?请务必访问: CCC认证网
Worldwide food standards & regulations: