II类：Post-market Surveillance Plan of XXX--医疗器械上市后监督计划 MDR.docVIP

Confidentiality:This

Confidentiality:This

Post-MarketSurveillancePlan

for

XXXX

Controlledstate：

Rev.:

A/1

Responsibility

Position

Signature

Date

Draft

Review

Approval

Content

TOC\o2-2\h\z\u1. Purpose 3

2. Scope 3

3. Responsibilities 3

4. PMSInput 3

5. DataSummary 7

6. DiscussionofData 7

7. Conclusions 15

8. DocumentConservation 15

9. Reference 15

RevisionHistory 17

Purpose

Asapartofpost-marketsurveillancesystem,toestablishaproactiveandsystematicprocesstocollectanyrelevantdataonthequality,performanceandsafetyofadevicethroughoutitsentirelifetimeasaninputintoclinicalevaluations,riskanalysisandothertechnicaldocumentationandtodrawingthenecessaryconclusionsandtodetermining,implementingandmonitoringanypreventiveandcorrectiveactions.

Scope

Thescopeofthispost-marketsurveillanceplancoversallthespecificationsofSterileBiliaryStoneRetrievalBalloonCatheter.

Note:Productclassification:ClassIIa.

Responsibilities

ThetableinthePMSinputssectiondefinesthepersonnelthatareresponsibleforgatheringeachtypeofPMSdataforSterileBiliaryStoneRetrievalBalloonCatheter.Eachpersonisresponsibleforgatheringthedata,summarizingthatdata,writingabriefdiscussionofthedataanalysisanddocumentingaconclusionthatstateswhetherthedatawarrantsupdatingthePSURreportatthistimeortocontinuegatheringdatauntilthenextcycleiscompleted.Ifnonewclinicaldataisgatheredduringtheperiod,thenthereisnoneedtoupdatetheclinicalevaluationreport.Ifnonewrisksareidentifiedandthedataindicatenochangetothecurrentriskanalysis,thenitmaynotbenecessarytoupdatetheriskanalysis.

PMSInput

ThefollowingtableidentifiesthePSURreportinputsforSterileBiliaryStoneRetrievalBalloonCatheter.

Item

DescriptionofInput

Methodsofcollectingdata

ResponsiblePerson

FrequencyofReview

1

Vigilance