美国FDA 医疗器械体系法规QSR820中英文对照(九)

Subpart M--Records 记录Sec. 820.180 General requirements.一般要求 All records required by this part shall bemaintained a

Subpart M--Records 记录

Sec. 820.180 General requirements.一般要求

All records required by this part shall bemaintained at the manufacturing establishment or other location that isreasonably accessible to responsible officials of the manufacturer and toemployees of FDA designated to perform inspections. Such records, includingthose not stored at the inspected establishment, shall be made readilyavailable for review and copying by FDA employee(s). Such records shall belegible and shall be stored to minimize deterioration and to prevent loss.Those records stored in automated data processing systems shall be backed up.


(a) Confidentiality.Records deemed confidential by the manufacturer may be marked to aid FDA indetermining whether information may be disclosed under the public informationregulation in part 20 of this chapter.

a)保密性。制造商应标识认为是保密的记录,以帮助FDA按照本章part 20公众信息法规的要求确定其信息是否公开。

(b) Recordretention period. All records required by this part shall be retained for aperiod of time equivalent to the design and expected life of the device, but inno case less than 2 years from the date of release for commercial distributionby the manufacturer.


(c) Exceptions.This section does not apply to the reports required by 820.20(c) Managementreview, 820.22 Quality audits, and supplier audit reports used to meet therequirements of 820.50(a) Evaluation of suppliers, contractors, andconsultants, but does apply to procedures established under these provisions.Upon request of a designated employee of FDA, an employee in management withexecutive responsibility shall certify in writing that the management reviewsand quality audits required under this part, and supplier audits whereapplicable, have been performed and documented, the dates on which they wereperformed, and that any required corrective action has been undertaken.

c例外。本部分虽然不适用于Sec.820.20c所要求的管理评审、Sec.820.22质量审核的报告,同时也不适用于用于满足Sec.820.50a)供应商(suppliers, contractors, and consultants)评价的供应商审核报告,但是适用于依据这些规定建立的程序。依据FDA检查员的要求,制造商*负责人应以书面形式证明,本部分所要求的管理审核、质量审计以及相应的供应商审计活动已经得以实施并予以记录,实施的日期和相应的纠正预防措施应包含记录当中。

Sec. 820.181 Device master record.器械主记录

Each manufacturer shall maintain device masterrecords (DMR's). Each manufacturer shall ensure that each DMR is prepared andapproved in accordance with 820.40. The DMR for each type of device shallinclude, or refer to the location of, the following information:


(a) Device specifications including appropriatedrawings, composition, formulation, component specifications, and softwarespecifications;


(b) Production process specifications includingthe appropriate equipment specifications, production methods, productionprocedures, and production environment specifications;


(c) Quality assurance procedures andspecifications including acceptance criteria and the quality assuranceequipment to be used;


(d) Packaging and labeling specifications,including methods and processes used; and


(e) Installation, maintenance, and servicingprocedures and methods.


Sec. 820.184 Device history record.器械历史记录

Each manufacturer shall maintain device historyrecords (DHR's). Each manufacturer shall establish and maintain procedures toensure that DHR's for each batch, lot, or unit are maintained to demonstratethat the device is manufactured in accordance with the DMR and the requirementsof this part. The DHR shall include, or refer to the location of, the followinginformation:


(a) The dates of manufacture;  制造日期

(b) The quantity manufactured; 生产数量

(c) The quantity released for distribution; 放行用于销售的数量

(d) The acceptance records which demonstratethe device is manufactured in accordance with the DMR; 证明器械依据DMR进行生产的检验记录。

(e) The primary identification label andlabeling used for each production unit; and用于每个生产单元的主要标识标签和标签;并且

(f) Anyunique device identifier (UDI) or universal product code (UPC), and any otherdevice identification(s) and control number(s) used.使用的UDIUPC,以及其他器械标识和控制码

文件修订历史:[61 FR 52654, Oct. 7,1996, as amended at 78 FR 55822, Sept. 24, 2013]

Sec. 820.186 Quality system record. 质量体系记录

Each manufacturer shall maintain a qualitysystem record (QSR). The QSR shall include, or refer to the location of,procedures and the documentation of activities required by this part that arenot specific to a particular type of device(s), including, but not limited to,the records required by 820.20. Each manufacturer shall ensure that the QSR isprepared and approved in accordance with 820.40.


Sec. 820.198 Complaint files. 投诉文档

(a) Each manufacturer shall maintain complaintfiles. Each manufacturer shall establish and maintain procedures for receiving,reviewing, and evaluating complaints by a formally designated unit. Suchprocedures shall ensure that:


(1) All complaints are processed in a uniform andtimely manner; 所有投诉都应及时的按既定的程序进行处理。

(2) Oral complaints are documented upon receipt;and 口头投诉应当予以记录,并且

(3) Complaints are evaluated to determine whetherthe complaint represents an event which is required to be reported to FDA underpart 803 of this chapter, Medical Device Reporting.


(b) Each manufacturer shall review and evaluateall complaints to determine whether an investigation is necessary. When noinvestigation is made, the manufacturer shall maintain a record that includesthe reason no investigation was made and the name of the individual responsiblefor the decision not to investigate.


(c) Any complaint involving the possible failureof a device, labeling, or packaging to meet any of its specifications shall bereviewed, evaluated, and investigated, unless such investigation has alreadybeen performed for a similar complaint and another investigation is notnecessary.


(d) Any complaint that represents an event whichmust be reported to FDA under part 803 of this chapter shall be promptlyreviewed, evaluated, and investigated by a designated individual(s) and shallbe maintained in a separate portion of the complaint files or otherwise clearlyidentified. In addition to the information required by 820.198(e), records ofinvestigation under this paragraph shall include a determination of:


(1) Whether the device failed to meetspecifications; 器械是偏离标准的要求。

(2) Whether the device was being used fortreatment or diagnosis; and 器械是否用于治疗和诊断,并且

(3) The relationship, if any, of the device tothe reported incident or adverse event.如果有,解释器械与所报告事件或不利影响之间的关系。

(e) When an investigation is made under thissection, a record of the investigation shall be maintained by the formallydesignated unit identified in paragraph (a) of this section. The record ofinvestigation shall include:


(1) The name of the device; 器械的名称;

(2) The date the complaint was received;接到投诉的日期;

(3) Any unique device identifier (UDI) oruniversal product code (UPC), and any other device identification(s) andcontrol number(s) used;使用的UDIUPC,以及其他器械标识和控制号;

(4) The name, address, and phone number of thecomplainant;投诉者的姓名、地址、电话号;

(5) The nature and details of the complaint; 投诉的细节和性质;

(6) The dates and results of the investigation; 检查的结果和日期;

(7) Any corrective action taken; and 所有纠正措施;并且

(8) Any reply to the complainant.  所有投诉的回复。

(f) When the manufacturer's formally designatedcomplaint unit is located at a site separate from the manufacturing establishment,the investigated complaint(s) and the record(s) of investigation shall bereasonably accessible to the manufacturing establishment.


(g) If a manufacturer's formally designatedcomplaint unit is located outside of the United States, records required bythis section shall be reasonably accessible in the United States at either:


(1) A location in the United States where themanufacturer's records are regularly kept; or


(2) The location of the initial distributor.



[61 FR 52654, Oct. 7, 1996, as amended at 69 FR11313, Mar. 10, 2004; 71 FR 16228, Mar. 31, 2006; 78 FR 55822, Sept. 24, 2013]





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