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食品、医疗器械、化妆品、OTC药品FDA注册、FDA验厂咨询服务 QQ 3007276201 电话 13661555246 张女士
21CFR part 807.40(a) 规定任何从事生产、准备、组合或加工成品医疗器械并将产品进口到美国的美国海外厂商都需要进行工厂注册(EstablishmentRegistration)和医疗器械列示(MedicalDevice Listing)。
美国境外企业的美国代理人的信息使用FDA Unified Registration and Listing System (FURLS system) 以电子方式提交，并且是企业注册流程的一部分。每个外国企业只能指定一名美国代理人。
外国企业也可以（但不是必须）指定其美国代理人作为其官方通讯员。外国企业应提供美国代理人的名称，地址，电话和传真号码以及电子邮件地址。
确定的美国代理人将被要求完成自动程序以确认他们已同意担任美国代理人。自动程序会将电子邮件验证请求转发给美国代理人。他们将被要求确认她/他同意代表外国企业担任代表/联络人。如果美国代理人拒绝同意（或在10个工作日内没有回复），外国企业的官方通讯员/所有者运营商将收到通知，并且必须指定一名新的美国代理人以履行监管义务。
根据联邦法规807.40(b)的要求，美国代理人的职责包括以下：
1）根据FDA的要求，协助FDA与国外厂商沟通；
2）对国外厂商进口到美国的产品出现的问题进行回复；
3）帮助FDA安排国外厂商的厂商检查活动；
4）如果FDA无法直接或迅速联系外国企业，FDA可能会向美国代理人提供信息或文件，此类行为应被视为等同于向外国企业提供相同的信息或文件。
请注意，美国代理人不负责根据医疗器械报告法规（21 CFR Part 803）报告不良事件，或提交510（k）上市前通知（21 CFR Part 807，Subpart E）。
技术支持有：
510k注册
工厂注册和产品列名
产品列名
美国代理人
FDA 预提交
FDA验厂QSR820
凭借全球网络和专业队伍为全球客户提供法规性服务，帮助企业消除贸易壁垒，在医疗器械行业尤为专长。这主要包括：欧盟CE认证（MDD/MDR）、欧盟授权代表、医疗器械欧盟注册、自由销售证书、FDA注册、FDA验厂、ISO9001/ISO13485，药监局注册证、生产许可证等项目。
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.
The U.S. agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the U.S. agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the U.S. agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new U.S. agent to satisfy the regulatory obligation.
Responsibilities of a U.S. agent
The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.
The responsibilities of the U.S. agent are limited and include:
assisting FDA in communications with the foreign establishment,
responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
assisting FDA in scheduling inspections of the foreign establishment and
if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E). |
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发表于 2019-8-16 14:25:00