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[医疗保健]美国客人要你做QSR820体系 进来可以帮助你解决

楼主#
更多 发布于:2014-01-26 12:41
企业出口医疗产品美国需要注册FDA, 其中对企业要求建立QSR 820 质量管理体系

美国FDA QSR820质量体系

 

什么是美国FDA QSR820质量体系
FDA QSR820也叫QSR (Quality System Regulation) ,是21 CFR 820的一种简易叫法。
美国国会是法律的制定机构.其制定的《联邦食品药品和化妆品法案(Federal Food, Drug and Cosmetic
Act)》是美国关于医疗器械管理的最高法律性文件。
 
美国食品药品监督管理局(FDA)是负责医疗器械管理的政府机构。其根据各相关法律授权而制定的各类法规性的文件编号为21CFRxxxx(xxxx为阿拉伯数字)。
其中21CFR820是FDA根据<联邦食品,药品和化妆品法案>第501、502、 510、 513、 514、 515、 518、 519、 520、 522、 701、 704、 801、 803条款的授权而制定的规范医疗器械企业质量体系要求的法规,即Quality System Regulation,简称QSR或QSR820。
 
QSR
820质量体系规范中描述了现行的生产管理规范的要求(CGMP)。本规范要求规定了所有医用器械成品在设计、制造、包装、标签、贮存、安装和服务中使用的方法,设施和控制。这些要求是为了确保医疗器械成品的安全和有效,并遵从美国食品药品和化妆品法。本规范提出了适用于医疗器械成品制造商的基本要求,如果某制造商只进行本规范规定的一部分操作,而不进行其他操作,则该制造商仅需执行适用于他所进行操作的那些要求。有关1类器械,设计控制仅按在§820.30(a)(2)中列出的要求进行。这个规范不适用于成品组件和零件的制造商,但鼓励这样的制造商使用规范的适当规定作为指导。
 
谁要遵守QSR820?
21QSR820.1规定,所有在美国和波多黎各境内的,或者有产品出口到美国和波多黎各境内的医疗器械企业必须按QSR820的要求建立质量体系。各企业可以根据实际情况,满足QSR中与自己活动相关的条款。
 
QSR820不适用于医疗器械零件生产商,但FDA鼓励这类企业以QSR820中适用的条款为指导。
QSR820不适用于人血和血制品生产商,这类企业应遵循21CFR606的规定。
 
谁来检查企业是否符合QSR820?
FDA下属的CDRH(器械与放射健康中心)是专职负责医疗器械企业管理的政府机构,其根据FDA的授权安排检查员到个企业进行工厂检查。对美国境内企业一般每两年检查一次,境外企业不定期检查。所有检查费用由FDA承担,检查只是一个符合性检查,不颁发任何证,不属于认证活动。
 
QSR820全文的内容是什么?
参见QSR820中文全文,请点击此处“QSR820中文全文”
参见QSR820英文全文,请点击此处“QSR820英文全文”
参见QSR820质量体系地图,请点击此处“美国FDA QSR820质量体系地图”
 
我们提供的服务包括:
1) 审核企业目前已经建立的医疗器械质量体系
2) 根据审核结果提出整改意见,并完善现有的体系,达到FDA QSR 820的规定
3) 提供企业培训提升企业从上到下的员工对于美国FDA QSR820质量体系的认识
4) 模拟FDA QSR820工厂审核
5) 长期为企业提供跟进评审服务
 
我们具有丰富的QSR820质量体系管理经验,成功协助包括多家上市企业在内的医疗器械企业建立和完善了美国FDA QSR820体系。

如果你公司出口美国又没建立这个体系 欢迎来咨询 medicaldevice@qq.com

QSR 820 法规从1996年发布以来,历史上进行了6次小型的技术修改。如下

PART 820—QUALITY SYSTEM REGULATION
7. The authority citation for 21 CFR part 820 continues to read as follows:
Authority: 351, 352, 360, 360c, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383.
8. Amend § 820.1 by removing paragraphs (e) and (f).

Change restored paragraph (e) to 820.1 Scope.
PART 820—QUALITY SYSTEM REGULATION
5. The authority citation for 21 CFR part 820 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383.
6. Section 820.1 is amended by adding paragraph (e) to read as follows:
§ 820.1 Scope.
* * * * *
(e) Exemptions or variances. (1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in § 10.30 of this chapter, the FDA’s administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Small Manufacturers Assistance (HFZ–220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1–800–638–2041 or 1–301–443–6597, FAX 301–443–8818.

(2) FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.

69 FR 11313
(10-Mar-2004)  Change removed reference to 21 CFR 804, which was deleted from the CFR.

PART 820—QUALITY SYSTEM REGULATION
14. The authority citation for 21 CFR part 820 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l 371, 374, 381, 383.
15. Section 820.198(d) is revised to read as follows
§ 820.198 Complaint files.
* * * * *
(d) Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by § 820.198(e), records of investigation under this paragraph shall include a determination of:
(1) Whether the device failed to meet specifications;
(2) Whether the device was being used for treatment or diagnosis; and
(3) The relationship, if any, of the device to the reported incident or adverse event.
* * * * *
16. Section 820.200(c) is revised to read as follows:
§ 820.200 Servicing.
* * * * *</P> [/td][/tr][tr][td][/td][td]<P>c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 820.198.<

(
Changed to specifically note applicability of 21
CFR 820 to tissue products, under newly released 21 CFR 1271.</P><SPAN class=text>Also, the Quality System regulation contains a typographic error: it has a date of 2005, but 2004 is the correct date.

PART 820—QUALITY SYSTEM REGULATION
6. The authority citation for 21 CFR part 820 is revised to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.
7. Section 820.1 is amended by adding two sentences to the end of paragraph (a)(1), and by revising paragraph (b) to read as follows:
§ 820.1 Scope.
(a) Applicability. (1) * * *
Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in § 1271.3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.
* * * * *
(b) The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.

71 FR 16228
(31-Mar-2006)
3. The authority citation for 21 CFR part 820 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383.

4. Amend paragraph (a)(3) of § 820.198 by removing ‘‘or 804’’

(09-Apr-2007)</P>Change updated title, address, and phone numbers for DSMICA.
PART 820—QUALITY SYSTEM REGULATION</P>6. FDA is revising Sec.  820.1(e) and replacing “Division of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-8818” with “Division of Small Manufacturers, International and Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.”
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发布于:2014-01-26 15:50
祝大家新年快乐!!!!!!
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板凳#
发布于:2014-01-27 11:44
谢谢eric的分享!
如果能将实际申请流程分享出来就更好啦!!
开心工作,认真生活!
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