NEW MARKETS ARE READY…

Your job is to develop medical devices that

improve the delivery of care. Our job is

to certify the safety of these devices and

to help you get them to multiple global

markets quickly to an audience that’s

eager to accept them. UL’s Health Sciences

industry delivers innovative, customer

focused, market access solutions locally.

LET’S GET MOVING

When: DuringDesignPhase

Purpose: Assessdesignincludingthe componentselections

Value: AccesstoaULengineerearlyinthe designprocessandidentificationof potentialareasofnon-conformitybefore youcommittocertificationtesting

> Deliverable: Completeandintegratedtestreport planforthemarketsyouneed

Put time on Your Side

Closing the distanceA host of divergent standards and processes for testing and

certification stand in the way of timely access. You need a

partner that knows the fastest, most efficient route to new

markets. Wherever you’re going, UL will get you there in a

timely manner.

Streamlining the processWith just one product submission, you can receive the

test reports you need to complete your technical files.

We can also provide any specific certificates needed

to indicate your product’s compliance with local and

global regulations and industry standards.

Ourcomprehensiveassessmentprocessassessesthesafetyandreliabilityof

yourproductaccordingtothestandardsofeachregulatorybody.Ourthird-party

testreportsassistinobtainingimmediateaccesstoandrecognitionwithinthe

marketsyouvaluethemost.

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WITh UL, YOUR ADMINISTRATIVE AND PROjECT

MANAGEMENT ACTIVITIES ARE CUT TO A MINIMUM.

Since approximately 63% of medical devices fail certification testing the first time through, our two-stage process to certification helps you build in conformity, reduce rework and get to market more quickly.

2 STAGE ASSESSMENT PROGRAM

When: AfterStage1onproductionsamples

Purpose: Provideindependent3rdpartytest reportsyoucanuseforglobal regulatorysubmissions

Value: Lesssurprisesduringcertification,reduction ofcostsassociatedwithreworkandamore predictableproductlaunch

> Deliverable: ULprovidescertificationformultiple markets,includingtheULMarkfortheUS

• DesignReview

• Stage1Assessment

• RiskManagementReview/GapAssessment

• MaterialsCharacterization

• UsabilityReview

• StandardsReviewandMarketRequirementsReview

• PublicandPrivateTrainings

Product Concept/ Design Development

• Stage1Assessment

• Wireless,Interoperability,Security&EMCServices

• SoftwareReviews

• ClinicalResearchOrganization(Trials)

• BiocompatibilityandAnalyticalChemistry

• PackagingValidationsandreview

Design Realization

• CBCertification

• Stage2Assessment

• TechnicalFileReviews

• QualityManagementSystemsCertification

• CountryThirdPartyRegulatoryapprovals(INMETRO,JPAL,SFDA,CMDCASetc…)

• ApplicationAssistance(Taiwan,Korea)

Market Access/Product Commercialization

hOW UL SUPPORTS YOU DURING ThE MEDICAL PRODUCT DEVELOPMENT PROCESS

1 2

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A start to finish comprehensive program that moves your product through global approvals.

YOUR TEChNICAL FILE

With integrated assessments, UL gives you the data to support multiple regulatory submissions.

• CSAC22.2No.601.1Canadarequirements

• EMC—IEC60601-1-2

• ANSI/UL60601USrequirements

• CBScheme“MED”

• NBRIEC60601-1Brazilrequirements

• EN60601EUrequirements

• JIS60601Japanrequirements

> Base Standard: IEC 60601-X-X

Integrated Safety Certification Assessment

Integrated Quality & Management Systems Assessment

Pre-clinical Analytical Testing & Verification Services

• ISO13485

• FDAQSR

• JapanMONo.169

• ISO13485underCMDCAS

• EUAnnexesunderMDDandIVDD

• ISO14971

> Base Standard: ISO 13485

• Biocompatibility—ISO10993,USP

• Sterility—ISO11137

• Packaging—ISO11607

• Physico-chemical

• Clinicalinvestigationsusing—ISO14155

> And other applicable standards

European Union Regulatory Approvals

Regulatory approvals for global emerging markets

Canadian Regulatory Approvals

Japanese Regulatory Approvals

FDA Approvals

BrazilianApprovals

Chinese Approvals

REGULATORY SUBMISSIONS WITh UL

NO MATTER WhERE YOU DO BUSINESS,

WE’RE ALREADY ThERE.

Global market acceSS + univerSal recoGnition

Reach globally. Serve locally. UL can help you with global certification and regulatory services

locally through our worldwide offices. You get to interact with

someone in your own language and within your time zone who

can assess your products and management systems to standards

and regulations required for local and global acceptance.

The expertise you need. The service you deserve.With UL as your partner, you have a single point of contact to

manage your project delivery team, fluent in your language

and business practices. When it comes to comprehensive

service every step of the way, we provide everything you need.

Intermsofglobalreach,ULhasnopeers.Ourknowledgenetworkspans71countries,pluswe

provideaccesstoallmajormarkets,includingtheUS,Europe,Canada,Japan,Brazil,Taiwan

andChina.ULprovidesyouwithdedicatedlocalprojectmanagementandtechnicalteamsno

matterwhereyouare,plusend-to-endglobalregulatorysolutionswhereveryouwanttogo.

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INTEGRATED PRODUCT SAFETY TEST REPORTS & CERTIFICATION FOR GLOBAL MARKET ACCESS

Country Service Mark or Deliverable

Global BiocompatibilityTesting Third Party Test Report

NCBunderIECEECBSchemewithmultiple,globalCBTLs

CB Test Certificate

Stabilityofdevicesandtheirpackagingsystemduringtheshelflifeandtransportation

Third Party Test Report

Validationofcleaning,disinfectionandsterilization

Third Party Test Report

MicrobiologicalandVirologicalTesting Third Party Test Report

Testingofophthalmicdeviceslikeintraocularlenses,contactlensesandlenscareproducts

Third Party Test Report

EMC,WirelessSecurityandinteroperabilityvalidationtestingandmitigation

Third Party Test Report

Brazil TestingtoIEC/NBRStandardsresultinginINMETROCertification

Canada ClassificationtoCanadianSafetyStandards

Denmark D-MarkCertification

EU TestingToENStandards Third Party Test Report

japan TestingandCertificationtoJISstandards Third Party Test Report

US ClassificationtoUL60601andANSI/AAMI606013rdEdition

CertificationtoUL2560forNursecallequipment

MARKET ENTRY ASSESSMENT / AUThORIzED ThIRD PARTY ASSESSMENT

Country Service Mark or Deliverable

EU IVDNotifiedBody

MDDNotifiedBody

japan PAL3rdPartyRecognizedCertificationBody

Approval from MhLW

US FDA510(k)3rdPartyReview FDA SE Letter

OPERATION / MANUFACTURING SYSTEM REGISTRATION

Country Service Mark or Deliverable

Global ISO9000andISO13485Registration

ISO14971Registration

Canada ULisarecognizedregistrarunderHealthCanada’sCMDCASprogram

japan PAL3rdPartyRecognizedCertificationBody

Approval from MhLW

Taiwan TCPProgramallowingmanufacturerstousetheirUL-UKissuedMDDorIVDDcertificatetoapplyforTaiwanapproval

Taiwan approval

Get to market QuicklY and confidentlY

UL will test your devices to the appropriate internationally

harmonized standards and where UL is a recognized third-party

reviewer or Notified Body, UL will assess your technical file for

compliance with regulatory requirements. In many cases, we

can get your product approved for multiple markets through a

single submission.

Certificate transferIf you already have an ISO 13485 registration or your product

is covered by a different Notified Body, we can review your last

few audit reports and very often issue a new certificate or allow

you to transfer to UL without an additional on-site audit. After

deciding which markets you intend to launch your product,

contact the nearest UL office. Your project management

team will help you determine which marks will be required,

if sterilization and packaging validation is needed and which

regulatory bodies will be involved.

Afterdecidingwhatmarketsyouintendtolaunchyourproduct,contactthenearestULoffice.

Yourprojectmanagementteamwillhelpyoudeterminewhichtestswillberequiredand

whichregulatorybodieswillbeinvolved.

1. Market DeterminationIn which markets will the device be sold?

3. Regulatory Approvals BodiesProduct launch

4. Periodic AuditInternational Quality and Product Safety Programs

2. Single SubmissionTechnical file review

4 STEP SIMPLE TRANSFER PROCESS

REGULATORY APPLICATION SERVICES

Country Service Mark or Deliverable

China ExperiencedSFDAApplicationServices Approval from SFDA

Korea ExperiencedKFDAApplicationSer-vices

Approval from KFDA

CLINICAL RESEARCh ORGANIzATION

Country Service Mark or Deliverable

Global •Writingstudydocuments.e.g.informedconsentform,clinicalinvestigationplan,casereportforms.

•Manageandmonitortheclinicaltrials

•Choosethesitesandinvestigators

•EnsureGoodClinicalPracticeISO14155

•RegulatoryAffairsspecialists

•StatisticalEvaluationofthestudy

Third Party Test Report

GLOBAL REGULATORY SERVICES FOR ThE hEALTh SCIENCES INDUSTRIES

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the comPanY You keePWhatdoourinitialsdoforyou?Athird-partytestreportfromULdelivers

marketequityforstakeholdersandincreasesthelegitimacyofyour

productwithregulatorybodiesworldwide.HavingULattachedtoyour

productcreatesasenseoftrustforconsumersthroughouttheworld

regardingsafetyandquality.Ifyouwanttomakeanameforyourselfin

globalmarkets,ournamewilltakeyoualongway.

Global leadership speaks for itself in dozens of languages:

• COmpreHeNSIve ServICeS — UL provides end-to-end testing,

global regulatory and 3rd party certification services for the

Health Sciences industries.

• ACCeSS frOm A SINGLe SOUrCe — UL maintains global

accreditations and staff certifications that allow us to provide

integrated audits, covering multiple regulatory requirements at

once, avoiding redundant audits.

• THe LeAdING 510(k) 3rd pArTY revIeWer — UL has reviewed

more 510(k)s than any other 3rd party reviewer under the fdA 3rd

party review program set up by the medical device User fee and

modernization Act of 2002.

• THe #1 CB TeST CerTIfIer — UL has been the #1 issuer of CB Test

Certificates since 2002 for the category “med”.

• fIrST IN ISO 14971 reGISTrATION — UL issued the industry’s first

ISO 14971 registration in 2007.

• A WOrLd LeAder IN preSeNTING ANd pUBLISHING —

UL publishes articles and conducts presentations at industry

conferences on topics critical to medical device developers on

the world stage.

• UNBIASed revIeWS — UL experts participate in standards

development at the international level on multiple fronts.

• A LeAder IN CerTIfICATION fOr eLeCTrOmedICAL

eqUIpmeNT — UL is the #1 certification agency for

electromedical equipment in the U. S.

• eUrOpeAN NOTIfIed BOdY — UL is one of only a handful of

european Notified Bodies under the Ivd directive (Ivdd) and

only one of a few that have full device, technology and

conformity assessment route scope under the Ivdd.

leadinG the Pack

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UNderWrITerS LABOrATOrIeS333 pfINGSTeN rOAdNOrTHBrOOk, IL 60062

UL and the UL logo are trademarks of UL LLC © 2012. 450/2m/12/11 BdI 110906 A4

UL is a premier global safety science company with more than 100 years of proven

history. employing more than 7,000 professionals in over 100 countries, UL is evolving

the future of safety with five distinct business units — product Safety, environment,

Life & Health, verification and University — to meet the expanding needs of

customers and the global public. for more information on UL’s family of companies

and network of 68 laboratory, testing and certification facilities, go to ul.com.

for a complete list of all UL enterprise contact information by location, visit www.ul.com/contactus

UL Health Sciences Industry contact email addresses by region:

www.ul.com/medical

North America healthSciencesNA@ul.com

South America healthSciencesLA@ul.com

europe healthSciencesEU@ul.com

Asia and others healthSciencesAP@ul.com