【医疗器械国外法规】Medical Device Reporting (MDR) regulation (21 CFR 803)

豌豆机枪

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 803 MEDICAL DEVICE REPORTING

Subpart A--General Provisions
§ 803.1 - What does this part cover?
§ 803.3 - How does FDA define the terms used in this part?
§ 803.9 - What information from the reports do we disclose to the public?
§ 803.10 - Generally, what are the reporting requirements that apply to me?
§ 803.11 - What form should I use to submit reports of individual adverse events and where do I obtain these forms?
§ 803.12 - Where and how do I submit reports and additional information?
§ 803.13 - Do I need to submit reports in English?
§ 803.14 - How do I submit a report electronically?
§ 803.15 - How will I know if you require more information about my medical device report?
§ 803.16 - When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
§ 803.17 - What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
§ 803.18 - What are the requirements for establishing and maintaining MDR files or records that apply to me?
§ 803.19 - Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
Subpart B--Generally Applicable Requirements for Individual Adverse Event Reports
§ 803.20 - How do I complete and submit an individual adverse event report?
§ 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?
§ 803.22 - What are the circumstances in which I am not required to file a report?
Subpart C--User Facility Reporting Requirements
§ 803.30 - If I am a user facility, what reporting requirements apply to me?
§ 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?
§ 803.33 - If I am a user facility, what must I include when I submit an annual report?
Subpart D--Importer Reporting Requirements
§ 803.40 - If I am an importer, what kinds of individual adverse event reports must I submit, when must I submit them, and to whom must I submit them?
§ 803.42 - If I am an importer, what information must I submit in my individual adverse event reports?
Subpart E--Manufacturer Reporting Requirements
§ 803.50 - If I am a manufacturer, what reporting requirements apply to me?
§ 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?
§ 803.53 - If I am a manufacturer, in which circumstances must I submit a 5-day report?
§ 803.56 - If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
§ 803.58 - Foreign manufacturers.
[/td][/tr][tr][td]Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Source: 70 FR 9519, July 13, 2005, unless otherwise noted

孙艳红

英文的，建议同步共享中文

毛毛球

看不懂啊！

sanchongyan

21 CFR 803

lvyan402

看着头疼啊

zcwzy

英文的，建议同步共享中文[/quote]
标题21——食品和药品
章,我——食品和药物管理局
卫生和人类服务
分章H——医疗设备
       
部分803        医疗设备的报告

部分——一般规定
   §803.1 ——这部分内容是什么?
   §803.3 ——FDA如何定义术语用于这部分?
   §803.9 ——我们的信息报告向公众披露?
   §803.10 ——一般来说,适用于我的报告要求是什么?
   §803.11 ——我应该用什么形式提交个人不良事件的报告和我在哪里得到这些表格吗?
   §803.12 ——我怎么提交报告和其他信息吗?
   §803.13 ——我需要提交报告在英语吗?
   §803.14 ——我怎么电子提交一份报告?
   §803.15 ——我怎么知道如果你需要更多的信息关于我的医疗器械报告吗?
   §803.16 ——当我提交了一份报告,报告中的信息构成一个承认设备造成或者促成可报告的事件吗?
   §803.17 ——什么是要求开发、维护和实现写MDR程序适用于我吗?
   §803.18 ——建立和维护MDR的要求是什么文件或记录,适用于我吗?
   §803.19 ——有豁免、方差或替代形式的不良事件报告要求?
部分B——通常适用要求个别不良事件报告
   §803.20 ——我怎么完成并提交个人不良事件报告吗?
   §803.21 ——我在哪里可以找到我的报告为不良事件编码使用医疗器械报告?
   §803.22 ——是什么情况下,我不需要提交一份报告吗?
部分C——用户设施的报告要求
   §803.30 ——如果我是一个用户设备,报告要求适用于我吗?
   §803.32 ——如果我是一个用户设备,什么信息我必须提出我个人不良事件报告吗?
   §803.33 ——如果我是一个用户设备,我必须包括当我提交年度报告吗?
部分D——进口商报告要求
   §803.40 ——如果我是一个进口商,什么样的个人不良事件报告我必须提交,当我必须提交他们的时候,我和谁必须提交他们?
   §803.42 ——如果我是一个进口商,什么信息我必须提出我个人不良事件报告吗?
部分E -制造商报告要求
   §803.50 ——如果我是一个制造商,报告要求适用于我吗?
   §803.52 ——如果我是一个制造商,什么信息我必须提出我个人不良事件报告吗?
   §803.53 ——如果我是制造商,在哪些情况下我必须提交日报告吗?
   §803.56 ——如果我是制造商,在什么情况下我必须提交一份补充或跟踪报告,这些报告的要求是什么?
   §803.58 ——外国制造商。