ISO/CE marking/ROSH/REACH/510K专区(510K registration process)

cyj147

回复 319# ken77


    BSI竟然还有这样的配套，我还真的不知道。我也是有上网找过BSI，但没深入了解，看来要打电话询问了。。。我之前原本还有机会去美国的AAMI拿QSR COURSE + EXAM， 那里知道到最后不了了之，好可惜。 不然可以在FDA方面发展。。其实我也是在三年前才接触ISO13485 和FDA QSR， 在新山MEDICAL 厂少到可怜，所已才想朝这方面发展。。。

ISO13485 LEAD ASSESSOR COURSE + EXAM会难考吗？？ 我还大算把ISO13485 背熟，应该很有帮助吧。。。

外国buyer 的agent， 我没听说过。可是听你说薪水真的还不错。。

cyj147

回复 320# ken77


    counsultancy line 我有想过，可能先进入AUDIT LINE拿经验，看看别人的INDUSTRY如何，不同人有不同的做法嘛。。。

care

基本上我只是公司里面的sales executive, 但是两个ISO 系统都是属于我管治范围

Vicky1314

基本上我只是公司里面的sales executive, 但是两个ISO 系统都是属于我管治范围
care 发表于 2011-1-18 17:50

很少听过sales executive管iso system的。钦佩！钦佩！
除了iso以外，我还接触不同的certification，如vds,afnor。基本上都是跟着iso的标准为本。
但，我想接触iso 13485。以目前情况来看，应该还不能实现。
老板要我先学iso 14001。唉！

ken77

很少听过sales executive管iso system的。钦佩！钦佩！
除了iso以外，我还接触不同的certification， ...
Vicky1314 发表于 19-1-2011 10:55 AM

    １４０００ 简单过 １２３８５。 １３４８５ 有很多 regulatory requirement 及 product recall 的要求。

754017

我是operation的，也是公司的QMR，目前在为公司setting up ISO...paper work 是多一点，就当是学东西咯，一个经验 ~~ 弱弱问一句，这对以后前途有什么帮助吗？

Vicky1314

我想请问关于PPAP的requirement。如果change plant layout需要submit PPAP 给customer吗?我在manual里面找不到，但我的上司一直说有。
希望有人能给我一个确实的答案。

Vicky1314

想请问谁有经验申请FDA for medical devices?

ken77

Ken哥， 你好
一路以来我都有在看《办公憩园》， 虽然都是在潜水

我先介绍我自己
我今年26岁， 本地大学毕业，在shah alam一间日本电子公司上班....
QA engineer, customer service section..... 简单来说， 就是要面对customer的，customer complaint, customer request... 有时需要去customer厂看看, 不过通常还是在公司... meeting, prepare report, 3D, 8D, evaluation report等等.....
算起来也工作了3年了.... 可是最近发觉自己好像遇到一些瓶颈....

我发现我自己越来越没兴趣在这一行了， 或是说我看不到自己的前途... 看了你开的帖ISO/CE marking/ROSH/REACH/510K专区
你提到过“其实如果有机会成为经理是不错的。 但是， 你的exposure 就没那么多了。 u will become expert in system, but 可能只是在你自己的那一行。” 这就是我说顾虑的， 会不会以后都局限自己在这个圈子呢？
然后customer complaint很多， 每天就是troubleshooting, find root cause, countermeasure, send 8D report.... 是, 是有学到东西， 不过都是soft skill.... communication skill, presentation skill, how to handle customer, 然后大概理解一间MNC company 的system... ISO system只懂表面，不是我不想学， 而是我的工作单单面对customer complaint就够了

ken哥， 就以上所讲的， 你有何意见？
看了你的ISO帖， 明白精通QMR真的对career path比较好...
请问做ISO consultant需要怎样的资格？

然后， 在customer service, 或多或少都会接触customer, 慢慢的发觉自己想试看做sales & marketing， 原因无他， 就想试看做business， 接触不一样的层面..... 你现在是在做business development对吗？ 当时为何你会从quality field 转进business 的？ 可以分享吗？

不好意思... 我的pm有点长


ken哥， 就以上所讲的， 你有何意见？

个人觉得，在QA line 毕竟是不错。 但是必须看性格。我的性格是比较喜欢与陌生人接触那种。所以我不适合在 operation。不过， 无论如何 行行出状元。最重要的是你必须精通你的工作。时常买书来看，多参加training。

看了你的ISO帖， 明白精通QMR真的对career path比较好...
请问做ISO consultant需要怎样的资格？

必须有set up system 的经验 或者 supplier audit 的经验。internal audit 而已是不大能帮你value added 的。 最好精通不同的system， 如 QMS， EMS， OSHA， TS１６９４９， MDOMS １３４８５， ５１０K， CE。。。。

然后， 在customer service, 或多或少都会接触customer, 慢慢的发觉自己想试看做sales & marketing， 原因无他， 就想试看做business， 接触不一样的层面..... 你现在是在做business development对吗？ 当时为何你会从quality field 转进business 的？ 可以分享吗？

分享， 我其实是误打误撞的进入 mkt咯。虽然那时候我非常想换去mkt。但是，没想到因为一些误会， 被打入冷宫。。接着。。。故事很长。。你自己去看回我以前写的故事。。。无间地狱。。。

wish u good luck...

ken77

想请问谁有经验申请FDA for medical devices?
Vicky1314 发表于 23-3-2011 05:40 PM

    i got experience.. 510k (FDA)

u mean 510k registration??

Vicky1314

回复 330# ken77


应该是吧。要如何申请510K?

ken77

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm#who

Premarket Notification (510k)

你是那一种device？ condom？ glove？ 还是其他的？

Who is Required to Submit a 510(k)
The Act and the 510(k) regulation (21 CFR 807) do not specify who must apply for a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission.

The following four categories of parties must submit a 510(k) to the FDA:

Domestic manufacturers introducing a device to the U.S. market;

Finished device manufacturers must submit a 510(k) if they manufacture a device according to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices. However, manufacturers of device components are not required to submit a 510(k) unless such components are promoted for sale to an end user as replacement parts. Contract manufacturers, those firms that manufacture devices under contract according to someone else’ s specifications, are not required to submit a 510(k).
Specification developers introducing a device to the U.S. market;

A specification developer develops the specifications for a finished device, but has the device manufactured under contract by another firm or entity. The specification developer submits the 510(k), not the contract manufacturer.
Repackers or relabelers who make labeling changes or whose operations significantly affect the device.

Repackagers or relabelers may be required to submit a 510(k) if they significantly change the labeling or otherwise affect any condition of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or adding warnings, contraindications, etc. Operations, such as sterilization, could alter the condition of the device. However, most repackagers or relabelers are not required to submit a 510(k).
Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.
Please note that all manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls (21 CFR 820.30) during the development of their device. The holder of a 510(k) must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (21 CFR 820) and may be subject to a new 510(k).  Please see our guidance, "Deciding When to Submit a 510(k) for a Change to an Existing Device4."

When a 510(k) is Required

A 510(k) is required when:

Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. If your device was not marketed by your firm before May 28, 1976, a 510(k) is required.
You propose a different intended use for a device which you already have in commercial distribution. The 510(k) regulation (21 CFR 8075) specifically requires a 510(k) submission for a major change or modification in intended use. Intended use is indicated by claims made for a device in labeling or advertising. Most, if not all changes in intended use will require a 510(k). Please note that prescription use to over the counter use is a major change in intended use and requires the submission of a new 510(k).
There is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. The burden is on the 510(k) holder to decide whether or not a modification could significantly affect safety or effectiveness of the device. Any modifications must be made in accordance with the Quality System regulation, 21 CFR 820, and recorded in the device master record and change control records. It is recommended that the justification for submitting or not submitting a new 510(k) be recorded in the change control records.

A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use. See Is a new 510(k) required for a modification to the device?6 for additional information.
When a 510(k) is Not Required
The following are examples of when a 510(k) is not required.

You sell unfinished devices to another firm for further processing or sell components to be used in the assembling of devices by other firms. However, if your components are to be sold directly to end users as replacement parts, a 510(k) is required.
Your device is not being marketed or commercially distributed. You do not need a 510(k) to develop, evaluate, or test a device. This includes clinical evaluation. Please note that if you perform clinical trials with your device, you are subject to the Investigational Device Exemption7 (IDE) regulation (21 CFR 812).
You distribute another firm's domestically manufactured device. You may place a label on the device, "Distributed by ABC Firm" or "Manufactured for ABC Firm," (21 CFR 801.18) and sell it to end users without submission of a 510(k).
In most cases, if you are a repackager or a relabeler you are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.
Your device was legally in commercial distribution before May 28, 1976 and you have documentation to prove this. These devices are "grandfathered" and have Preamendment Status9. You do not have to submit a 510(k) unless the device has been significantly modified or there has been a change in its intended use.
The device is made outside the U.S. and you are an importer of the foreign made medical device. A 510(k) is not required if a 510(k) has been submitted by the foreign manufacturer and received marketing clearance. Once the foreign manufacturer has received 510(k) clearance for the device, the foreign manufacturer may export his device to any U.S. importer.
Your device is exempted from 510(k) by regulation (21 CFR 862-892). That is, certain Class I or II devices can be marketed for the first time without having to submit a 510(k). A list of the Class I and II exempted devices can be found on Medical Device Exemptions 510(k) and GMP Requirements10. However, if the device exceeds the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9), such as the device has a new intended use or operates using a different fundamental scientific technology than a legally marketed device in that generic type of device, or the device is a reprocessed single-use device, then a 510(k) must be submitted to market the new device.
Preamendment Devices
The term "preamendments device" refers to devices legally marketed in the U.S. by a firm before May 28, 1976 and which have not been:

significantly changed or modified since then; and
for which a regulation requiring a PMA application has not been published by FDA.
Devices meeting the above criteria are referred to as "grandfathered" devices and do not require a 510(k). The device must have the same intended use as that marketed before May 28, 1976. If the device is labeled for a new intended use, then the device is considered a new device and a 510(k) must be submitted to FDA for marketing clearance.

Please note that you must be the owner of the device on the market before May 28, 1976, for the device to be grandfathered. If your device is similar to a grandfathered device and marketed after May 28, 1976, then your device does NOT meet the requirements of being grandfathered and you must submit a 510(k). In order for a firm to claim that it has a preamendments device, it must demonstrate that its device was labeled, promoted, and distributed in interstate commerce for a specific intended use and that intended use has not changed. See Preamendment Status11 for information on documentation requirements.

Third Party Review Program
The Center for Devices and Radiological Health (CDRH) has implemented a Third Party Review Program. This program provides an option to manufacturers of certain devices of submitting their 510(k) to private parties (Recognized Third Parties) identified by FDA for review instead of submitting directly to CDRH. For more information on the program, eligible devices and a list of Recognized Third Parties go to Third Party Review Program Information12 page.

ken77

回复  ken77


应该是吧。要如何申请510K?
Vicky1314 发表于 1-4-2011 09:18 AM

５１０K 是－premarket notification。 就是说如果医疗用品等要出口到美国前，你们必须要register 510k 。
Registration / Evaluation period minimum 6 months

接着submit sample给 FDA，同时你们必须要送你们的产品到external lab test。

不同的 medical device 所要求的test 也是不一样的。

同时他们也是会要求你们提供你们的产品的formulation，用的chemical等。全部必须要有 MSDS 来证明你们用的产品不伤害人体健康。

接着FDA会evaluate 你们的产品。

如果通过检验过后，你们就会得到 ５１０K 认证。如果你们客户要从美国进口你们的产品， 他们必须先用你们的５１０K 来向有关当局register。 过后才可以进口你们的产品。

但是，
５１０k register 时是用厂址来决定要不要接受你的申请。所以不管你register 几个５１０k，用不同公司注册也是没用。因为，一个地址只可以注册一个５１０k。除非，你老板设立很多的厂， 这么一来你就可以register 多几个不同的５１０K。

ken77

http://www.fda510k.com.tw/index.php?option=com_content&task=view&id=22&Itemid=69

FDA 510(k) 上市（出口）前通知申請介紹

任何人或製造商若要將醫療器材產品（Class I,II,III）行銷到美國，除部分免510(k)品項及無須進行上市前核准（Premarket Approval, PMA）外，都必須在進口美國至少90天前向美國食品藥品管理局（U.S.Food and Drug Administration,簡稱FDA）提出上市前通知（Premarket Notification,PMN）申請，取得輸入許可（510(k) Clearance Letter）。

Premarket Notification, 510(k):510(k)是向FDA提出的上市前申請文件，目的是證明申請510(k)的醫療器材不需進行上市前核准(PMA)且與已合法上市之產品具相同安全性及有效性，此即實質相等性(substantially equivalent)。

申請人或公司必須將欲申請上市的醫療器材與已在美國FDA上市之一種或多種相似產品做比對，證明其具實質相等性。

合法上市之器材之定義為在1976年5月28日之前合法上市的器材 (Preamendment device)，或者從第III類中重新分類入II或I類的器材，或者通過510(k)申請程序證明具實質相等性的器材，或者依III 類醫療器材評估定義的器材。這些醫療器材被稱為“predicate device(s)”。

申請者必須提出描述性的資料，必要的時候，要提出功能性報告來證明與predicate device的實質相等性。所以510(k)的資料是顯示比對性的資料，即新器材與predicate device的實質相等性。

綜合以上內容可知，絕大部分產品在完成企業註冊、產品列名和GMP品質系統，完成510（k）申請後，即可上市。

ken77

1．FDA對醫療器材的定義如下：

“所謂醫療器材是指符合以下條件的儀器、裝置、工具、機具、器具、插入管、體外試劑或其他相關物品，包括組件、零件或附件等：明列於官方National Formulary或美國藥典(the United States Pharmacopeia)或前述二者的附件中者；意圖使用於動物或人類疾病或其他身體狀況的診斷；或用於疾病之治癒、減緩、治療者；意圖影響動物或人類身體的功能或結構，但不經由動物或人類身體或身體上的化學反應來達成其首要目的，同時也不依賴新陳代謝來達成其主要目的”。

醫療器材依據風險等級的不同，FDA將醫療器材分為四類（Ⅰ，Ⅱ，Ⅲ，Unclassified），Ⅲ類風險等級最高目前FDA醫療器材品目項共有1，700多種。醫療器材想要進入美國市場，首先必須了解產品分類和管理要求。


2. FDA醫療器材相關法案有聯邦食品、藥品與化妝品法案（FD&C Act）；包裝和標識法案；健康和安全輻射控制法案；安全醫療器材法案；現代化法案等。

3. 醫療器材廠商在計畫進入美國市場前，需詳細評估針對自己產品相關的法規和具體要求（包括不同的產品標準要求）在詳細了解上述資訊後，企業就可以準備相關的申報資料，經由申請程序向FDA申請以取得核准及認可。  

4.對於任何產品，企業都需進行註冊（Establishment Registration）和產品列名（Device  Listing）。

·  Ⅰ類產品，需符合一般管制（General Control），絕大部分產品只需進行註冊、列名和實施GMP規範，產品即可進入美國市場（部分產品連GMP也免除，部分產品則需向FDA提出510（k）申請即PMN（Premarket Notification））

·  Ⅱ類產品則需符合特殊控制（Special Control），企業在進行註冊和列名後，還需實施GMP和提出510（k）申請（少數產品可免除510（k））

·  Ⅲ類產品，需進行上市前許可(即510(k))申請程序，企業在完成註冊和列名後，須實施GMP並向FDA提出PMA（Premarket Application）申請（部分Ⅲ類產品還是PMN）。


5.對於Ⅰ類產品，企業向FDA交相關資料後，FDA只進行公告，並無相關證書發給企業；對Ⅱ、Ⅲ類器材，企業須完成PMN或PMA，FDA在公告的同時，會給企業正式的市場核准函（Clearance Letter），企業即可以自己的名義在美國醫療器材市場上直接銷售其產品。至於申請過程中是否到企業進行現場GMP考核，則由FDA根據產品風險等級、管理要求和市場回饋等綜合因素決定。

綜合以上內容可知，絕大部分產品在完成企業註冊、產品列名和GMP品質系統，完成510（k）申請後，即可獲得FDA核准上市。

ken77

５１０k requires 的test 必须花好多钱。。。一个test大业 USD 几千。。。

Vicky1314

回复 336# ken77


如果那件医药用品已经得到FDA认证，只是多加生产地方，请问还是需要申请510k吗？

ken77

回复  ken77


如果那件医药用品已经得到FDA认证，只是多加生产地方，请问还是需要申请510k吗？
Vicky1314 发表于 4-4-2011 09:01 AM

re-submission...not need to apply the new one

ken77

Miss Vicky，

忘记问你

A） 你的process 有 major changes 吗？
B） 你的formulation 有改 (major)吗？

如果没的话。

个人觉得，不如静静咯。何必要自己挖洞给自己。你自己知道啦， GMP 一改。。很麻烦的。。。

你应该知道GMP 吧。

ken77

我是operation的，也是公司的QMR，目前在为公司setting up ISO...paper work 是多一点，就当是学东西咯，一 ...
754017 发表于 9-2-2011 11:02 PM

    通常会QMS 的人， 出路比较多咯。因为基本上他们已经了解不同部门的运作。