出口美國注意!已有74家中國生產企業獲EUA!附名單!

分類:海運新聞 來源:維運網 時間:2020/04/16

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1. 現在有針對中國KN95型口罩的EUA申請,FDA在短期內快速審核口罩的資料,并在關網上公布獲得EUA授權的企業和產品型號,相當于發一個簡易臨時的合格證替代NIOSH認證。


2、范圍是中國生產的一次性防護型口罩,就是立體的那種。醫用平面口罩不算在內。

3、什么機構可以申請EUA?

在FDA的指導里面寫明,可以申請EUA的目前有兩種機構:一是實驗室,可以申請EUA獲得檢測允許;第二種就是醫療器械公司,有研發制造能力的可以申請EUA,給器械獲取緊急時期的使用資格。

4、根據FDA文件,中國生產的口罩獲得EUA授權,需要滿足三個要求

一是擁有一個或多個NIOSH(美國國家職業安全衛生研究所)認證產品的制造商,按照其他國家/地區的適用授權標準生產的其他型號的過濾式面罩呼吸器(FFR),FDA可以進行驗證;

二是中國以外的其他地區授權的,FDA可以進行驗證;

三是有獨立的測試實驗室出具的檢測報告,能顯示其產品性能符合適用的測試標的,FDA可以進行驗證。


這其中最容易滿足的應該是第3個條件。注意:

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(EUA)有效期:這個授權僅在爆發期間有效,FDA認為結束的時候該EUA就會失效。疫情結束后需要重新做NIOSH認證

5、如何申請EUA

未在美國境內的上市的醫療用途的外科口罩、N95口罩,不管是美國境內還是境外制造商,都可以申請緊急授權。需要遞交以下資料,并發送到FDA 這個郵箱:[email protected],由FDA審核是否可以授予緊急授權,讓該產品在新冠疫情期間在美國境內銷售。

資料如下:

1、General information such as your contact information, name and place of business,email address, and contact information for a U.S. agent (if any) in addition to generalinformation about the device such as the proprietary or brand name, model number,and marketing authorization in your country (or region).

2、copy of the product labeling.

3、Whether the device currently has marketing authorization in another regulatory jurisdiction (including certification number, if available).

4、Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO13485: Medical Devices – Quality Management Systems – Requirements forRegulatory Purposes or an equivalent quality system and the manufacturer or importer has documentation of such.

5、Description of testing conducted on the device, including any standards met, such as

6、liquid barrier protection, flammability, biocompatibility, and filtration performance, asappropriate. For surgical N95 respirators, FDA recommends including fluid resistance testing (liquid barrier performance).

以上遞交資料適用于本來就已經生產醫療器械、但口罩尚未在美國境內上市的制造商。有兩點是需要注意的:

1、FDA只是減免了510(k)技術文檔要求,但關于產品測試,生產車間質量體系的要求是從未有放棄的;

2、在新冠肺炎疫情爆發期間內,FDA不拘泥于任何區域的產品標準,只要你是做相關產品測試,歐盟的、中國的,都可以將測試報告遞交,由FDA決定是否可以授予緊急授權。

此外,FDA也歡迎非醫療器械企業生產銷售醫療器械,可以粗暴理解成就是連生產車間QSR820都未外審過的制造商,至于要怎么操作,發郵件問FDA。

額外要求

FDA對于緊急授權下的口罩產品,有如下要求:

Appropriate conditions designed to ensure that health care professionals administering the device are informed—

that FDA has authorized the emergency use of the device;

of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown;

of the alternatives to the device that are available, and of their benefits and risks.

Appropriate conditions designed to ensure that individuals to whom the device is administered are informed—

that FDA has authorized the emergency

of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown;

of the option to accept or refuse administration of the device, of the consequence,if any, of refusing administration of the device, and of the alternatives to the device that are available and of their benefits and risks.

獲得EUA授權的口罩,要在包裝標識上明確這是FDA緊急授權的產品。

冠狀病毒?。–OVID-19)緊急使用授權(EUA)信息官網:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

文章來源:12360海關熱線,維運網綜合整理匯編轉載請注明


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