RepublicofthePhilippines
Department ofHealth
OFFICEOFTHESECRETARY
JAN262018
ADMINISTRATIVE ORDER
No.%9-l;i/- 20l3-0002
SUBJECT: Guidelines Governing theIssuanceofanAuthorization foraMedical
DevicebasedontheASEANHarmonized Technical Requirements
I.RATIONALE
Thefastevolutionofmedicaltechnology andtheessentialroleofmedicaldevices
inthehealthcaredeliverysystemhavehighlighted theimportance ofensuringthesafety
andeffectiveness ofthesedevicesthroughregulation whilefacilitating tradeamongthe
tenmemberstatesoftheAssociation ofSoutheast AsianNations(ASEAN). Structured
andregionally accepted technical requirements weredeveloped throughtheASEAN
Consultative Committee onStandards andQuality—MedicalDeviceProductWorking
Group(ACCSQ-MDPWG).
Thedevelopment ofthecommon submission dossiertemplate (CSDT)wasa
‘combined effortoftheASEAN member statestakingintoconsideration theglobal
technical requirements developed bytheGlobalHarmonization TaskForce.TheCSDT
isasetoftechnical requirements fortheregistration ofthemedicaldeviceproductsagreed
uponbythetenASEANmembercountries. ThePhilippines iscommitted toalignits
regulatory guidelines withthissetoftechnical requirements, thustheissuanceofthis
Administrative Order.
Pursuant toRepublic ActNo.9711,theFoodandDrugAdministration (FDA)Act
of2009anditsimplementing RulesandRegulations (IRR),thisAdministrative Order
(A0)isbeingissuedtogovernthenewsetsofdocumentary requirements forthe
registration ofmedicaldeviceproducts.
II.OBJECTIVE
ThisOrderaimstoprovideguidelines onthedocumentary requirements forthe
registration ofmedicaldevicesandtoaligntheregistration requirements totheCSDT
basedontheprovisions oftheASEANMedicalDeviceDirective.
Building 1,SanLazaroCompound, RizalAvenue, Sta.Cruz,1003Manila 0TrunkLine651-7800 local1113,08,1135/ DirectLine:711-9502; 711-9503 Fax:743-1829 0URL:http://www.doh.gov.ph; e-mail:ofﬁceofsoh a.,do.ov11
III.SCOPE
Thenewdocumentary requirements shallapplytoallmedicaldevicestobesold,
imported, exported, manufactured, andusedinthePhilippines, exceptin—vitrodiagnostic
andrefurbished medicaldevices,forwhichseparateAdministrative Ordersshallbeissued.
IV.DEFINITION OFTERMS
ForthepurposeofthisAdministrative Order,thetermsbelowshallbedeﬁnedas
follows:
1.Applicant—referstoanyindividual, partnership, corporation, association, and/or
organization, eitheramanufacturer, trader,distributor/importer/ exporter
applying foraCMDN, aCMDL,and/oraCMDRasdeﬁnedbelow.
Authorization ~referstoanycertiﬁcation issuedtotheapplicant byCDRRHR
showingtheproducthascomplied ondocumentary andtechnical requirements
suchasNotiﬁcation andRegistration withcertiﬁcate.
CenterforDeviceRegulation, Radiation HealthandResearch (CDRRHR)—
referstotheregulatory ofﬁceundertheFoodandDrugAdministration (FDA)of
theDepartment ofHealth(DOH)thatisinchargeoftheregulation ofmedical
devicesinthePhilippines.
Certiﬁcate ofMedical DeviceNotiﬁcation (CMDN)—referstothe
authorization issuedforamedicaldevicethatcomplies withalltherequirements
forNotiﬁcation ofamedicaldevice.TheCMDNisissuedformedicaldevices
thatwillfallunderclassA.
Certiﬁcate ofMedical DeviceRegistration (CMDR)—referstothe
authorization issuedforamedicaldevicethatcomplies withalltherequirements
forRegistration ofamedicaldevice.TheCMDRisissuedformedicaldevices
thatfallunderclassesB,C,andD.
Certificate ofMedical DeviceListing(CMDL)—-referstotheauthorization
issuedforamedicaldevicethatisintended forresearch, clinicaltrial,exhibit,
donation, etc.andthatisnotintendedforsale.
Common Submission DossierTemplate (CSDT) -isasetoftechnical
requirements agreeduponbythetenmembercountriesoftheASEANwhichshall
governtheregulation ofmedicaldevicesintheASEAN.
Countryoforigin—referstothecountrywherethedeviceismanufactured or
wherethedevicehasbeenregistered and/orhasbeenissuedamarketapproval
priortodistribution inthePhilippines.
Distributor/importer/exporter -meansanymedicaldeviceestablishment that
importsorexportsrawmaterials, activeingredients and/orﬁnishedproducts for
itsownuseorforwholesale distribution tootherestablishments oroutlets
10.
11.
12.
13.
14.
15.Distributor/wholesaler -meansanymedicaldeviceestablishment thatprocures
rawmaterials, activeingredients and/orﬁnished products fromlocal
establishments forlocaldistribution onawholesale basis.
In-Vitro Diagnostic Medical Device —referstoanyreagent,reagentproduct,
calibrator, controlmaterial, kit,instrument, apparatus, equipment orsystem
whetherusedaloneorincombination, intendedbythemanufacturer tobeused
in-vitrofortheexamination ofspecimens, including bloodandtissuedonation,
derivedfromthehumanbodysolelyorprincipally forthepurposeof
providing information concerning aphysiological orpathological state;or
providing information concerning acongenital abnormality; or
determining thesafetyandcompatibility withpotential recipients; or
monitoring therapeutic measures.9'.“9‘?”
LegalManufacturer —meansanyforeignmedicaldeviceestablishment with
responsibility forthedesign,manufacture, packaging andlabelingofadevice
beforeitisplacedinthemarketunderhisownname,regardless ofwhetherthese
operations arecarriedoutbythatpersonhimselforonhisbehalfbyathirdparty.
LicensetoOperate(LTO)—referstotheauthorization issuedbytheFDAtoa
person orestablishment tooperate asamanufacturer, trader,
distributor/importer/exporter/wholesaler ofmedicaldevices.
Manufacturer —referstoanymedicaldeviceestablishment engagedinanyand
alloperations involved intheproduction ofamedical deviceincluding
preparation, processing, compounding, formulating, ﬁlling,packing, repacking,
altering,ornamenting, ﬁnishing andlabelingwiththeendinViewofitsstorage,
saleordistribution.
Medical Device —meansanyinstrument, apparatus, implement, machine,
appliance, implant, invitroreagentandcalibrator, software, materialorother
similarorrelatedarticle:
0intended bythemanufacturer/product ownertobeused,aloneorin
combination, forhumanbeingsforoneormoreofthespeciﬁcpurpose(s)
of
-diagnosis, prevention, monitoring, treatment oralleviation of
disease;
-diagnosis, monitoring, treatment, alleviation oforcompensation for
aninjury;
-investigation, replacement, modiﬁcation, orsupportoftheanatomy
orofaphysiological process;
-supporting orsustaining life;
-controlofconception;
-disinfection ofmedicaldevices;
-providing information formedicalordiagnostic purposes bymeans
ofinvitroexamination ofspecimens derivedfromthehumanbody;
and
16.
17.
18.
19.
19.
20.
21.0whichdoesnotachieveitsprimaryintended actioninoronthehuman
bodybypharmacological, immunological ormetabolic means,butwhich
maybeassistedinitsintendedfunctionbysuchmeans.
MedicalDeviceSystem—iscomposedofdifferentmedicaldeviceswhereineach
deviceisessentialintheoperationofthesystem.
Notiﬁcation—-istheprocessofseekingauthorization tomanufacture, import,
export,selland/ordistribute ClassAmedicaldevicesinthePhilippines.
ProductOwner —inrelationtoamedical device,meansanypersonwho:
a.suppliesthemedicaldeviceunderhisownname,orunderanytrademark,
design,tradenameorothernameormarkownedorcontrolled byhim;
and
b.isresponsible fordesigning, manufacturing, assembling, processing,
labelling, packaging, refurbishing ormodifying themedicaldevice,orfor
assigning toitapurpose,whetherthosetasksareperformed byhimoron
hisbehalf.
Product Standards —referstomedical devicestandards set,formulated,
developed, and/orestablished byanyofthefollowing:
BureauofProductStandards (Philippine National Standard),
International Organization forStandardization (ISO),
International Electrotechnical Commission (IEC),
OtherInternational Standard Bodiesrecognized bytheDOH,or
Anyforeignstandards thatmayberecognized bytheDOHforthepurpose
ofregistration.sup-99‘s»
Refurbished Medical Device —referstoamedicaldevicethatwaspreviously
ownedandreconditioned forre—saleandmeetsthesafetyandperformance
parameters setbythemanufacturer.
Registration—meanstheprocessofapprovalofanapplication toregistermedical
devicepriortoengaging inthemanufacture, importation, exportation, sale,offer
forsale,distribution, transfer,andwhereapplicable, theuse,testing,promotion,
advertisement, and/orsponsorship ofmedicaldeviceproducts.
Trader —meansanylocalestablishment thatisaregistered productownerofa
medicaldevice,procurestherawmaterials andpackingcomponents, andprovides
theproduction monographs, qualitycontrolstandards andprocedures, but
subcontracts themanufacture ofsuchproduct toalicensedmanufacturer. In
addition, atradermayalsoengageinthedistribution and/ormarketing ofits
products.
V.GENERAL GUIDELINES
1.Theclassiﬁcation systemofmedicaldevicesinthisAdministrative Ordershall
followtheclassiﬁcation systemasagreedonbytheACCSQ-MDPWG whichisrule-
basedandaccording tothelevelofrisklistedbelow:
Class RiskLevel
A Low
B Low-moderate
C Moderate-high
D High
Aguidance document containing thelistofmedicaldevicesperclassiﬁcation shall
beissued.Reclassiﬁcation ofcertaindevicescanbedonewhenthelevelofriskof
thedeviceischangedbyacertainincidentinthemanufacture, distribution oruseof
thedevice.Thisshallbedoneuponproperconsultation withtheadvisorycommittee
createdbythePhilippine FDAand/ortheASEANforthispurpose.
Theapplicant shallclassifythedevicebasedonthelistofmedicaldevicesper
classiﬁcation issuedbytheCDRRHR. Iftheproductisnotincludedinthelist,the
company shallclassifythedevicebasedontheintendeduseandontheclassiﬁcation
rulesoftheASEAN Medical DeviceDirective. TheCDRRHR shallverifythe
classiﬁcation madebytheapplicant andshallreclassify thedeviceifanother
classiﬁcation isdeemedtobemoreappropriate.
AllmedicaldevicesunderclassAshallapplyfornotiﬁcation ofthemedicaldevice
product,whileallmedicaldevicesunderclassesBtoDshallapplyforregistration
ofthemedicaldeviceproduct.
TheNotiﬁcation NumberorRegistration Numbershallbeissuedtothedevicewith
anapproved CMDNorCMDR.TheCMDNandtheCMDRshallbevalidforﬁve
(5)yearsandshallberenewedeveryﬁve(5)yearsaftertheinitialapproval.
Thedistributor/local manufacturer ofthedeviceshallinformtheCDRRHR in
writingWithinthirty(30)calendardaysincasethedistributor/ localmanufacturer has
ceasedtheproduction ordistribution ofsuchdevice.
Thelistofallapproved CMDRsandCMDNsshallbepostedintheFDAwebsite.
Medicaldevicesstrictlyforresearch, clinicaltrial,exhibit,and/ordonatedbrandnew
medicaldevicesareexempted fromNotiﬁcation andRegistration. However, the
researcher, institution, and/oruserofsuchdevicesshallapplyforaCertiﬁcate of
MedicalDeviceListing.
TheCDRRHR reservestherighttoaskforanyotherrequirements notindicated in
thisOrderbutdeemednecessary tosupportthereliability andauthenticity ofthe
submitted documents andsafetyofthemedicaldeviceproduct;orthatmayarise
basedonthesubmitted compliance documents.
Disapproved applications shallbereturnedtotheapplicant. Incasetheapplicant does
notclaimthedisapproved applications within90calendar days,theapplication
documents shallbedestroyed anddiscarded.
VI.SPECIFIC GUIDELINES
1.Anapplication shallbemadeseparately foreachspeciﬁcmedicaldevice.Incaseof
thefollowing conditions, onlyoneapplication canbeﬁled;however, separate
certiﬁcates ofproductregistration shallbeissued:
a.amedicaldevicewith.accessories whereintheaccessories areintended to
besoldseparately,
b.amedical device,ownedbythesamelegalmanufacturer, thatis
manufactured indifferentmanufacturing plantsandwillbebothdistributed
atthesametimeinthePhilippine market,
0.amedicaldevicesystemwheretheuseofonepartofthesystemisneeded
tobeusedtogetherwithalloranypartofthesystem,
(1.medicaldeviceswiththesameintended useandthesamemanufacturing
processbutdifferinoneormorerawmaterials,
6.medicaldeviceswiththesameintended useandthesamemanufacturing
processbutdifferinthedesign,
f.medicaldeviceswiththesamerawmaterials butdifferintypesorshapes
resulting indifferentspeciﬁcintendeduse.
2.Theregistration feeforapplication meetingtheabovementioned condition/s shallbe
equivalent tothetotalregistration feeforalltheindividual products thatwillbe
registered.
VII.PROCEDURAL GUIDELINES
A.Initial
1.Allapplications withdeﬁciencies shallbegivenaone-time compliance
periodofamaximum ofninety(90)calendardays.Ifthedeﬁciencies were
notcomplied duringthecompliance period,theapplication shallbe
considered disapproved. However, theapplicant mayopttosubmitare-
application withinsixty(60)calendar daysafterthedisapproval. Ifno
compliance isreceived withinthesetcompliance period,theapplication
shallbeautomatically considered disapproved.
2.ProductlabelsofthemedicaldeviceswithissuedCMDRorCMDNshall
havethefollowing national labeling requirements priortosaleand
distribution:
a.Nameandaddressoftheimporter
b.Nameandaddressofthedistributor (ifexclusive distributor)
c.CMDNnumberorCMDRnumber.
3.Documentary Requirements
a.Thelistofrequirements fortheNotiﬁcation ofClassAmedical
devices&Registration ofClassesB,CandDmedicaldevicesareas
follows(attached asAnnexes):
a.1AnnexA—LegalRequirements forApplication forthe
Notiﬁcation ofMedical Devices underClassAand
Registration ofMedicalDevicesunderClassesB,Cand
D
a.2AnnexB—Technical Requirements forApplication for
theNotiﬁcation ofMedicalDevicesunderClassA
a.3AnnexC—Technical Requirements fortheInitial
Registration ofMedical Devices underClassBin
Accordance withtheCSDTTemplate
a.4AnnexD—Technical Requirements fortheInitial
Registration ofMedical Devices underClassCin
Accordance withtheCSDTTemplate
a.5AnnexE—Technical Requirements fortheInitial
Registration ofMedical Devices underClassDin
Accordance withtheCSDTTemplate
b.TheCDRRHreservestherighttoaskforadditional documents not
indicated inthisOrderthatmayarisebasedonthesubmitted
compliance documents
4.Theapplication shallbeevaluated withinonehundredeighty(180)days
uponﬁlingoftheapplications. Allapplications thatdonotcomplywith
,thetechnical requirements shallbenotiﬁedthrough aletterandshallbe
givenaone-time chancetocorrectthedeﬁciencies withinninety(90)days.
Iftheapplicant stillfailstocomplywiththerequirements, he/shewillbe
givenachancetore-apply, withacorresponding fee,andtosubmitthe
complete compliance documents withinsixty(60)days.Failuretocomply
withtherequireddocumentation withinthegivenperiodshallbeaground
fordisapproval oftheapplication.
B.Renewal
1.Theﬁlingfortherenewalofthecertiﬁcates ofregistration ornotiﬁcation
shallbeaccepted withinninety(90)calendardayspriortotheexpirydate
oftheCMDRorCMDN.
2.Applications forrenewalofcertiﬁcates ofregistration ornotiﬁcation ﬁled
afterthevaliditydateshallbeﬁnedwiththecorresponding penaltyin
accordance withtheexistingrulesandregulations onfeesandcharges.
3.Anapplication forrenewalofCMDRﬁledafteronehundredtwenty(120)
calendar daysafteritsexpiration shallnotbeaccepted andshallbe
considered aninitialapplication. Thedistribution andsaleofthatmedical
deviceshallautomatically stopuntilsuchtimethatthecertiﬁcation of
productregistration havebeenapproved. Theapplicant canopt,however,
torequesttheretentionoftheproductregistration/notiﬁcation number.
4.Theapplication forrenewalshallbeevaluated withinthirty(30)daysupon
ﬁlingoftheapplication. Allapplications thatdonotcomplywiththe
technical requirements shallbenotiﬁedthroughaletterandshallbegiven
aone-time chancetocorrectthedeﬁciencies withinthirty(30)da3.
w
7
5.Therequirements fortherenewalareattached asAnnexF,Requirements
fortheRenewalofNotiﬁcation/Registration ofMedicalDevicesforall
classiﬁcations.
C.MedicalDeviceListing
1.Theﬁlingofapplication forMedicalDeviceListingshouldbemadeprior
totheimportation ofthemedicaldevices.
2.Thelistofrequirements forMedicalDeviceListingareattached asAnnex
G,Requirements fortheApplication ofMedicalDeviceListing.
VIII.FEESANDCHARGES
ThescheduleoffeesandchargesshallfollowDOHAONo.50s.2001andits
amendments andrevisions.
IX.PHASES OFIMPLEMENTATION
ThisA0shallcoverinitiallyallregistrable products listedinFDAMemorandum
CircularNo.2014-005: “Updated ListofMedicalDevicesrequired toberegistered prior
tosale,distribution anduse”anditsamendments; theNotiﬁcation ofallclassAmedical
devices;andtheMedicalDeviceListing.TheCDRRHR shallreleasethelistofmedical
devicesperclassiﬁcation basedontheclassiﬁcation setforthintheASEAN Medical
DeviceDirective.
Therequirement ofregistration forallmedicaldevicesnotindicated inthelistof
registrable medical devicesshallbeimplemented inphases. Thescheduleof
implementation shallbeissuedinseparatememoranda. Thephasesarelistedasfollows:
1.Phase1:Notiﬁcation ofClassB,CandDthatarenon-registrable medicaldevices
basedonFDAMemorandum CircularNo.2014-005.
2.Phase2:Registration ofClassD(Notiﬁcation ofClassDshallceaseduringthis
phase)
3.Phase3:Registration ofClassBandClassC(Notiﬁcation ofclassesBandC
shallceaseduringthisphase)
X.SANCTIONS
Thefollowing arethegroundsfordisapproval, cancellation, revocation and/or
non-renewal ofaCMDNandaCMDR:
l.Themanufacture, sale,offerforsale,ortransferofamedicaldevicethatdoesnot
meetalltherequirements ofsafetyandeffectiveness;
2.Misrepresentation orconcealment ofsigniﬁcant dataorinformation aboutthe
productsoughttoberegistered;
3.Alteration, mutilation, destruction, obliteration, orremovalofanypartofalabel‘
W
8
4.Amedicaldevicethathasabiological, chemical orphysicalproperty thatmay
causeanunacceptable healthrisk;
5.Submission offalsiﬁeddocument(s);
6.Alteration orfalsiﬁcation ofanissuedCMDNorCMDR.
Thesanctions hereinareinaddition totheappropriate sanctions listedintheFDA
Actof2009anditsImplementing RulesandRegulations.
XI.MOTION FORRECONSIDERATION/APPEAL
Theprocedure fortheﬁlingofMotionforReconsideration orAppealshallbein
accordance withtheprovisions stipulated inRepublic Act9711anditsImplementing
RulesandRegulations.
XII.CONFIDENTIALITY OFINFORMATION
Anyofﬁcersandemployees ofCDRRHR shallnotmakepublicorusefortheir
ownpersonalgainanytradesecretorproprietary information whichtheyobtainorbecome
familiarwithduringthecourseoftheirofﬁcialduties.Anyofﬁcialwhoviolatesthis
provision shallbedealtwithinaccordance withtheCodeofConductforPublicOfﬁcials.
XIII.SEPARABILITY CLAUSE
IfanyportionorprovisionofthisOrderisdeclaredinvalidorunenforceable or
unconstitutional, thevalidityorenforceability oftheremaining portionsorprovisions shall
notbeaffected, andthisOrdershallbeconstrued asifitdidnotcontaintheparticular
invalidorenforceable orunconstitutional portionorprovision.
XIV.REPEALING CLAUSE
FDAMemorandum CircularNo.2014-005, Updated ListofMedical Devices
required toberegistered priortosaledistribution anduse,andallotherissuances
inconsistent withtheprovisionofthisOrderareherebyrepealedormodiﬁed accordingly.
XV.EFFECTIVITY
ThisAOshalltakeeffectﬁfteen(15)daysfollowing thecompletion ofits
publication intwo(2)newspapers ofgeneralcirculation andﬁlingofthree(3)copies
hereoftotheUniversity ofthePhilippines OfﬁceoftheNational Administrative Register
(UPONAR).
Theimplementation oftheregistration ofmedicaldevicesfollowing thenewset
ofregulatory requirements shallbeone(1)yearaftertheeffectivityofthisAdministrative
Order.
TheCDRRHR mayallowthevoluntary submission ofapplications usingthenew
setofrequirements earlierthantheindicated implementation ofthisguidelines.
UQUEIII,MD,MSc
SeretaryofHealth
10
ANNEX A
LegalRequirements forApplication fortheNotiﬁcation ofMedicalDevicesunder
ClassAandRegistration ofMedicalDevicesunderClassesB,CandD
1.
2.
3.Notarized Application Form(AnnexGorH)
Payment
CopyofLetterofAuthorization. Forimported medicaldevices,thecopyof
theLetterofAuthorization shallbeaccompanied byanoriginalcopyofa
notarized declaration fromthelegalmanufacturer orproductownerattesting
thattheauthorization istrueandcorrect.
Agovernment—issuedcertiﬁcate attesting tothestatusoftheManufacturer
withregardtothecompetence andreliabilityofthepersonnel andfacilities,
aQualitySystemsCertiﬁcate ofapproval, oracompliance certiﬁcate forISO
13485.Forimported medicaldevices,thecopyofthecertiﬁcate shallbe
accompanied byanoriginalcopyofanotarized declaration fromthelegal
manufacturer orproductownerattesting thatthecertiﬁcate istrueand
correct.
Forimported medical devices, theCertiﬁcate ofProductNotiﬁcation,
Certiﬁcate ofProductRegistration, oranyequivalent document attesting to
thesafetyandeffectiveness ofthedeviceissuedbytheregulatory agencyor
accredited notiﬁedbodyinthecountryoforigin.Thecopyofthecertiﬁcate
shallbeaccompanied byanoriginalcopyofanotarized declaration fromthe
legalmanufacturer orproductownerattestingthatthecertiﬁcate istrueand
correct.
Coloredpictureofthedevicefromallsides.However, theCDRRHR can
requirearepresentative sampleorcommercial presentation forveriﬁcation
purposes.
11
ANNEX B
Technical Requirements forApplication fortheNotiﬁcation ofMedicalDevices
underClassA
1.Devicedescription consisting ofthefollowing:
a.Intendeduse
b.Instruction foruse
0.Listofallrawmaterials
(1.Technical speciﬁcation oftheﬁnishedproduct
e.Listofreference codes,sizes,colors,modelsandvariance, whichever
isapplicable.
2.Certiﬁcate ofConformity (issuedbygovernment agencydealingwith
metrology) ontheaspectofmanufacture relatingtometrology fordevices
withmeasuring functions,ifapplicable
3.Declaration ofConformity (selfdeclaration bythemanufacturer) with
productstandards,ifapplicable
4.Clearandcomplete coloredpicturesoflabelfromallsidesofthepackaging
(looselabelorartworksofalllayersofpackaging)
5.Declaration ofshelflife
12
ANNEX C
Technical Requirements fortheInitialRegistration ofMedicalDevicesunderClassBin
Accordance withtheCSDTTemplate
1.Executive Summary. Theexecutive summary shallincludethefollowing
information:
a.
worm?anoverview, e.g.,introductory descriptive information onthe
medicaldevice,theintended usesandindications foruseofthe
medicaldevice,anynovelfeatures andasynopsisofthecontentof
theCSDT;
thecommercial marketing history;
theintendedusesandindications inlabeling;
thelistofregulatory approvals ormarketing clearances obtained;
thestatusofanypendingrequestformarketclearance; and
theimportant safety/performance relatedinformation.
2.Relevant essentialprinciples andmethod/s usedtodemonstrate conformity,
ifapplicable. (SeeAnnexK)
3.Devicedescription withthefollowing information:
r'P‘qorm9-99‘s»IntendedUse
Indications ofuse
Instruction foruse
Contraindications
Warnings
Precautions
Potential adverseeffects
Alternative therapy(practices andprocedures)
Materials. Adescription ofthematerialsofthedeviceandtheir
physical properties totheextentnecessary todemonstrate
conformity withtherelevantEssential Principles. Theinformation
shallinclude complete chemical, biological andphysical
characterization ofthematerialsofthedevice.
OtherRelevant Speciﬁcations toincludethefollowing:
j.lThefunctional characteristics andtechnical performance
speciﬁcations ofthedeviceincluding, asrelevant:
accuracy, sensitivity, speciﬁcity ofmeasuring and
diagnostic medicaldevices,reliability, andotherfactors
j.2Ifapplicable, otherspeciﬁcations including chemical,
physical, electrical, mechanical, biological, software,
sterility,stability,storageandtransport, andpackaging.
OtherDescriptive Information todemonstrate conformity withthe
relevantEssential Principles (e.g.biocompatibility categoryforthe
ﬁnishedmedicaldevice)
4.SummaryofDesignVeriﬁcation andValidation Documents:
Thevalidation documents shallconsistofthefollowing:
a.
b.Declaration/Certiﬁcates ofConformity totheproductstandards
issuedbythemanufacturer
Summaries orreportsoftestsandevaluation basedonother
standards, manufacturer methodsandtests,oralternative waysof
demonstrating compliance, suchasalistingofandconclusions
13
NF"drawnfrompublished reportsthatconcern thesafetyand
performance ofaspectsofthemedicaldevicewithreference tothe
Essential Principles;
0.Datasummaries ortestsreportsandevaluations covering the
following appropriate testreports,whichever isapplicable:
c.1Engineering test
02Laboratory test
c.3Biocompatibility test
c.4AnimalTest
05Simulated Use
0.6Software Validation
c.7Pre-clinical studies
Clearandcomplete coloredpicturesoflabelinallanglesofthepackaging (loose
labelorartworksofalllayersofpackaging)
RiskAnalysis toincludetheresults
PhysicalManufacturer information
a.Manufacturing process, including qualityassurance measures.
Thisshouldincludethemanufacturing methods andprocedures,
manufacturing environment orconditions, facilities andcontrols.
Theinformation maybepresented intheformofaprocessﬂow
chartshowinganoverviewofproduction, controls,assembly, ﬁnal
producttesting,andpackagingofﬁnishedmedicaldevice.
b.Abriefsummaryofthesterilization methodshouldbeincluded.
14
ANNEX D
Technical Requirements fortheInitialRegistration ofMedicalDevicesunderClassCin
Accordance withtheCSDTTemplate
1.Executive Summary. Theexecutive summary shallincludethefollowing
information:
a.
“urea-99‘anoverview, e.g.,introductory descriptive information onthe
medicaldevice,theintended usesandindications foruseofthe
medicaldevice,anynovelfeaturesandasynopsisofthecontent
oftheCSDT;
thecommercial marketing history;
theintendedusesandindications inlabeling;
thelistofregulatory approvals ormarketing clearances obtained;
thestatusofanypendingrequestformarketclearance; and
theimportant safety/performance relatedinformation.
2Relevant essentialprinciples andmethod/s usedtodemonstrate conformity, if
applicable. (SeeAnnexK)
3.Devicedescription withthefollowing information:
#qurho999‘s»Intendeduse
Indications ofuse
Instruction foruse
Contraindications
Warnings
Precautions
Potential adverseeffects
Alternative therapy(practices andprocedures)
Materials. Adescription ofthematerialsofthedeviceandtheir
physical properties totheextentnecessary todemonstrate
conformity withtherelevantEssential Principles. Theinformation
shallinclude complete chemical, biological andphysical
characterization ofthematerialsofthedevice.
OtherRelevant Speciﬁcations toincludethefollowing:
j.1Thefunctional characteristics andtechnical performance
speciﬁcations ofthedeviceincluding, asrelevant:
accuracy, sensitivity, speciﬁcity ofmeasuring and
diagnostic medicaldevices,reliability, andotherfactors
j.2Ifapplicable, otherspeciﬁcations including chemical,
physical, electrical, mechanical, biological, software,
sterility,stability,storageandtransport, andpackaging.
OtherDescriptive Information todemonstrate conformity withthe
relevantEssential Principles (e.g.biocompatibility categoryforthe
ﬁnishedmedicaldevice)
4.Summary ofDesignVeriﬁcation andValidation Documents:
Thevalidation documents shallconsistofthefollowing:
a.Declaration/Certiﬁcates ofConformity totheproductstandards
issuedbythemanufacturer
b.Summaries orreportsoftestsandevaluation basedonother
standards, manufacturer methodsandtests,oralternative waysof
demonstrating compliance, suchasalistingofandconclusions
15
>19C.drawnfrompublished reportsthatconcern thesafetyand
performance ofaspectsofthemedicaldevicewithreference tothe
Essential Principles;‘
datasummaries ortestsreportsandevaluations covering the
following appropriate testreports,whichever isapplicable:
c.lEngineering test
c.2Laboratory test
c.3Biocompatibility test
c.4AnimalTest
05Simulated Use
d.Clinicalevidence forthefollowing:
d.1Implantable devices
d.2Newlyintroduced devices
d.3Devicesincorporating newmaterials comingintocontact
withthepatient.
d.4Existing materials appliedinabodypartnotpreviously
exposedtothatmaterial, andforwhichnopriorchemical
experience exists.
d.5Anexistingdevicethatismodiﬁed andthemodiﬁcation
mightaffectsafetyandeffectiveness.
6.Software validation studies,ifapplicable.
f.Biological evaluation, ifapplicable.
Clearandcomplete coloredpicturesoflabelfromallsidesofthepackaging (loose
labelorartworksofalllayersofpackaging)
Riskassessment consistingofriskanalysis,evaluation andreduction measures.
PhysicalManufacturer information
a.Manufacturing process, including qualityassurance measures.
Thisshould includethemanufacturing methodsandprocedures,
manufacturing environment orconditions, facilitiesandcontrols.
Theinformation maybepresented intheformofaprocessﬂow
chartshowinganoverviewofproduction, controls,assembly, ﬁnal
producttesting,andpackagingofﬁnishedmedicaldevice.
Abriefsummaryofthesterilization methodshouldbeincluded.
16
ANNEX E
Technical Requirements fortheInitialRegistration ofMedicalDevicesunderClassDin
Accordance withtheCSDT
1.Executive Summary. Theexecutive summary shallincludethefollowing
information:
a.anoverview, e.g.,introductory descriptive information onthemedical
device,theintended usesandindications foruseofthemedical
device,anynovelfeaturesandasynopsisofthecontentofthe
CSDT;
b.thecommercial marketing history;
0.theintendedusesandindications inlabeling;
d.thelistofregulatory approvals ormarketing clearances obtained;
e.thestatusofanypendingrequestformarketclearance; and
f.theimportant safety/performance relatedinformation.
2.Relevant essential principles andmethod/s usedtodemonstrate conformity, if
applicable. (SeeAnnexK)
3.Devicedescription withthefollowing information:
Intendeduse
.Indications ofuse
Instruction foruse
.Contraindications
Warnings
Precautions
.Potential adverseeffects
.Alternative therapy(practices andprocedures)
Materials. Adescription ofthematerialsofthedeviceandtheirphysical
properties totheextentnecessary todemonstrate conformity withthe
relevantEssential Principles. Theinformation shallincludecomplete
chemical, biological andphysicalcharacterization ofthematerialsofthe
device.
.
j.OtherRelevant Speciﬁcations toincludethefollowing:
j.1Thefunctional characteristics andtechnical performance
speciﬁcations ofthedeviceincluding, asrelevant:
accuracy, sensitivity, speciﬁcity ofmeasuring and
diagnostic medicaldevices,reliability, andotherfactors
j.2Ifapplicable, otherspeciﬁcations including chemical,
physical, electrical, mechanical, biological, software,
sterility,stability,storageandtransport, andpackaging.
k.OtherDescriptive Information todemonstrate conformity withthe
relevant Essential Principles (6.g.biocompatibility category forthe
ﬁnishedmedicaldevice)
4.SummaryofDesignVerification andValidation Documents:
Thevalidation documents shallconsistofthefollowing:
a.Declaration/Certiﬁcates ofConformity totheproductstandards issued
bythemanufacturer
b.Summaries orreportsoftestsandevaluation basedonotherstandards,
manufacturer methods andtests,oralternative waysofdemonstrating
compliance, suchasalistingofandconclusions drawnfrompublishedrumor-raga:190‘9:
17
(1°ngreportsthatconcernthesafetyandperformance ofaspectsofthe
medicaldevicewithreference totheEssential Principles;
Datasummaries ortestsreportsandevaluations coveringthefollowing
appropriate testreports,Whichever isapplicable:
c.1Engineering test
c.2Laboratory test
c.3Biocompatibility test
c.4AnimalTest
c.5Simulated Use
Clinicalevidence
Software validation studies,ifapplicable.
Biological evaluation, ifapplicable.
Abibliography ofallpublished reportsdealingwiththeuse,safety,and
effectiveness ofthedevice.
5.Clearandcomplete coloredpicturesoflabelfromallsidesofthepackaging (loose
labelorartworksofalllayersofpackaging)
6.Riskassessment consistingofriskanalysis,evaluation andreduction measures.
7.PhysicalManufacturer information
a.Manufacturing process,including qualityassurance measures. This
shouldinclude themanufacturing methods andprocedures,
manufacturing environment orconditions, facilitiesandcontrols. The
information maybepresented intheformofaprocessﬂowchart
showinganoverviewofproduction, controls, assembly, ﬁnalproduct
testing,andpackaging ofﬁnishedmedicaldevice.
Abriefsummaryofthesterilization methodshouldbeincluded.
18
ANNEX F
Requirements fortheRenewalofNotiﬁcation/Registration ofMedicalDevices
forAllClassiﬁcations
Notarized Application Form(AnnexHor1)
Payment
CopyofLetterofAuthorization. Forimported medicaldevices,thecopyofthe
LetterofAuthorization shallbeaccompanied byanoriginalcopyofanotarized
declaration fromthelegalmanufacturer orproductownerattesting thatthe
authorization istrueandcorrect.
4.Agovernment—issuedcertiﬁcate attesting tothestatusoftheManufacturer with
regardtothecompetence andreliabilityofthepersonnel andfacilities, aQuality
SystemsCertiﬁcate ofapproval, oracompliance certiﬁcate forISO13485.For
imported medicaldevices,thecopyofthecertiﬁcate shallbeaccompanied byan
originalcopyofanotarized declaration fromthelegalmanufacturer orproduct
ownerattestingthatthecertiﬁcate istrueandcorrect.
5.Coloredpictureofthedevicefromallsides.However, theCDRRHR canrequire
arepresentative sampleorcommercial presentation forveriﬁcation purposes.
6.Clearandcomplete coloredpicturesofcommercial labelfromallsidesofthe
packaging.UJNH
19
ANNEXG
Requirements forApplication fortheCertiﬁcate ofMedicalDeviceListing
1.Notarized Application Form(AnnexJ)
2.Notarized letteraddressed totheDirector, CenterforDeviceRegulation, Radiation
Health,andResearch, statingthatthemedicaldevicewillbeusedsolelyfor
research, analysis,orisbeingdonatedbyacertainorganization andisnotintended
forsale.Thelettershouldcontainthefollowing information:
a.Complete listofthedevicesindicating thequantity,brandandthe
nameofthemanufacturer oftheproduct
b.Declaration thattheorganization shallbethesoleentityresponsible
forthemedicaldevicesandthattheCDRRHR—FDA, DOHwillnotbe
heldliableforanysafetyissueconcerning theproduct.
Certiﬁcate ofProductNotiﬁcation orCertiﬁcate ofProductRegistration orany
equivalent document attesting tothesafetyandeffectiveness ofthedeviceissued
bytheregulatory agencyinthecountrywherethedevicewillcomefrom.
Foradonatedmedicaldevice(brandnew),acertiﬁedtruecopyofthedeedof
donation, thedeedofacceptance, andthepackinglistoranydocument thatwill
showthequantityoftheproduct.
5.CopyofSECorDTIregistration, whenapplicable
20
ANNEX H:APPLICATION FORMFORMEDICAL DEVICE NOTIFICATION
(www.fda.gov.ph)
TOTHEDIRECTOR GENERAL
FoodandDrugAdministration
Department ofHealth
ATTN:TheDirector
CenterforDeviceRegulation, Radiation Health,andResearch
Sir/Madam:
Inaccordance withRA.9711andotherrelatedissuance/s, wewishtoapplyforthe()initial()renewal
notiﬁcation ofourproduct.
APPLICATION FORMEDICAL DEVICE NOTIFICATION
DeviceName:
DeviceProprietary/Brand Name
Model/Reference Number/Property Code/Item Code:
IntendedUseofDevice:
Applicant’s Company Name:
Address:
LTONo. Validity:
TelNo.Fax.No. E-mailaddress:
Company President/ GeneralManager:
Regulatory Ofﬁcer:
LegalManufacturer(Product Owner):
Address:
Manufacturing site:
Weherebycertifythattheforegoing information andallotherdatasubmitted inconnection withthisapplication
aretrueandcorrect.Weunderstand thatthefailuretoreportallrequiredinformation orsubmission offalseor
misleading information isanoffensepunishable bylaw.Wecertifythatwehaveexamined thefollowing
statements andweattesttotheiraccuracy:
21
1.TheCurrentGoodManufacturing Practice/ QualityManagement System(ISO)isappliedinfull
inthemanufacture ofthisproduct.
Themanufacturing procedure isexactlyasspeciﬁed inthesubmitted manufacturing process.
3.Theﬁnishedproduct istestedandcertiﬁed tobefullycompliant withthespeciﬁcations inthe
accompanying documentation.N
4.Thepersonreleasing theproductforsaleisanauthorized and/orqualiﬁed person.
5.Theprocedures forcontroloftheﬁnishedproducthavebeenvalidated.
6.Theapplicant hasastandardoperating procedure forhandlinganyadverseeventrelatedtotheuse
ofthedevice.
7.Theapplicant hasastandardoperating procedure forhandlingproductrecalls.
8.Allthedocumentation referred tointhisapplication isavailable forreviewduringcomprehensive
inspection oftheestablishment.
9.Weshallchangethebrandnamesosubmitted shouldtheproperauthority decideswithﬁnality
thatwehavenorighttoappropriate andutilizethesaidbrandname;and
10.Weshallacknowledge andagreetoindemnify and/orholdFDAfreeandharmless againstanyand
allthirdpartyclaimsarisingfromtheacceptance ofsuchbrandnameoftheproductforregistration
withFDA.
11.Theproductcoveredbythisdeclaration willnotundergoanychangeintheownership, registrant’s
address/location, manufacturer, ingredients, formulation, size,reference number, use,
manufacturing process(ifapplicable), labelingorcommercial presentation, andpackaging ofthe
productcoveredbythiscertiﬁcate ofnotiﬁcation withoutpriorapprovalofthisofﬁce.
12.Weacknowledge andagreethatintheeventthatthereisanunauthorized changeintheownership,
itsaddress/location, manufacturer, ingredients, formulation, size,reference number, use,
manufacturing process(ifapplicable), labelingorcommercial presentation, andpackaging ofthe
product:
i.TheCDRRHR mayautomatically suspendtheLTOand/0rCMDNoftheproduct;
ii.Wewillvoluntarily recalltheproductﬁ'omthemarket;and
iii.Wewillindemnify and/orholdCDRRHR freeandharmless againstanyandallthird
partyclaimsand/oractionspertaining totheaboveunauthorized change(s).
Regulatory Ofﬁcer: Owner/General Manager:
SIGNATURE OVERPRINTED NAME SIGNATURE OVERPRINTED NAME
Government issuedIDNumber: Government issuedIDNumber:
DateIssued: DateIssued:
PlaceofIssuance: PlaceofIssuance:
SUBSCRIBED ANDSWORN beforemethis dayof afﬁantexhibiting to
mehis/herGovernment issuedIDNumberindicated above.
NOTARY PUBLIC
Doc.No.
PageNo.
BookNo.
Seriesof
22
ANNEX 1:APPLICATION FORMFORMEDICAL DEVICE REGISTRATION
(www.fda.gov.ph)
TOTHEDIRECTOR GENERAL
FoodandDrugAdministration
Department ofHealth
ATTN:TheDirector
CenterforDeviceRegulation, Radiation Health,andResearch
Sir/Madam:
Inaccordance withRA.971landotherrelatedissuance/s, wewishtoapplyforthe()initial()renewal
registration ofourproduct.
APPLICATION FORMEDICAL DEVICE REGISTRATION
DeviceName:
DeviceProprietary/Brand Name:
Model/Reference Number/Property Code/Item Code:
Classiﬁcation:
ClassB ClassC ClassD
IntendedUseofDevice:
Applicant’s Company Name:
Address:
LTONo. Validity:
TelNo. Fax.No. E-mailaddress:
Company Owner/General Manager:
Regulatory Ofﬁcer:
LegalManufacturer(Product Owner):
Address:
Manufacturing site:
Weherebycertifythattheforegoing information andallotherdatasubmitted inconnection withthisapplication
aretrueandcorrect.Weunderstand thatthefailuretoreportallrequiredinformation orsubmission offalseor
misleading information isanoffensepunishable bylaw.Wecertifythatwehaveexamined thefollowing
statements andweattesttotheiraccuracy:
23
1.TheCurrentGoodManufacturing Practice/ QualityManagement System(ISO)isappliedinfull
inthemanufacture ofthisproduct.
2.Themanufacturing procedure isexactlyasspeciﬁed inthesubmitted manufacturing process.
3.Theﬁnishedproduct istestedandcertiﬁed tobefullycompliant withthespeciﬁcations inthe
accompanying documentation.
4.Thepersonreleasing theproductforsaleisanauthorized and/orqualiﬁed person.
Theprocedures forcontroloftheﬁnishedproducthavebeenvalidated.
6.Theapplicant hasastandardoperating procedure forhandlinganyadverseeventrelatedtotheuse
ofthedevice.
.Theapplicant hasastandardoperating procedure forhandlingproductrecalls.
Allthedocumentation referredtointhisapplication isavailable forreviewduringcomprehensive
inspection oftheestablishment.
9.Weshallchangethebrandnamesosubmitted shouldtheproperauthority decidewithﬁnalitythat
wehavenorighttoappropriate andutilizethesaidbrandname;and
10.Weshallacknowledge andagreetoindemnify and/orholdFDAfreeandharmless againstanyand
allthirdpartyclaimsarisingfromtheacceptance ofsuchbrandnameoftheproductforregistration
withFDA.
11.Theproductcoveredbythisdeclaration willnotundergoanychangeintheownership, registrant’s
address/location, manufacturer, ingredients, formulation, size,reference number, use,
manufacturing process(ifapplicable), labelingorcommercial presentation, andpackaging ofthe
productcoveredbythiscertiﬁcate ofnotiﬁcation withoutpriorapprovalofthisofﬁce.
12.Weacknowledge andagreethatintheeventthatthereisanunauthorized changeintheownership,
itsaddress/location, manufacturer, ingredients, formulation, size,reference number, use,
manufacturing process(ifapplicable), labelingorcommercial presentation, andpackaging ofthe
product:
i.TheCDRRHR mayautomatically suspendtheLTOand/orCMDRoftheproduct
ii.Wewillvoluntarily recalltheproductfromthemarket;and
iii.Wewillindemnify and/orholdCDRRI-IR freeandharmless againstanyandallthird
partyclaimsand/oractionspertaining totheaboveunauthorized change(s).E"
.ooq
Regulatory Ofﬁcer: Owner/General Manager:
SIGNATURE OVERPRINTED NAME SIGNATURE OVERPRINTED NAME
Government issuedIDNumber: Government issuedIDNumber:
DateIssued: DateIssued:
PlaceofIssuance: PlaceofIssuance:
SUBSCRIBED ANDSWORN beforemethis dayof afﬁantexhibiting to
mehis/hergovernment issuedIDNumberindicated above.
NOTARY PUBLIC
Doc.No.
PageNo.
BookNo.
Seriesof
24
ANNEX J:APPLICATION FORM FORMEDICAL DEVICE LISTING
(www.fda.gov.ph)
TOTHEDIRECTOR GENERAL
FoodandDrugAdministration
Department ofHealth
ATTN:TheDirector
CenterforDeviceRegulation, Radiation Health,andResearch
Sir/Madam:
InAccordance withRA.9711andotherrelatedissuances, weWishtoapplyforthelistingofourproduct.
APPLICATION FORMEDICAL DEVICE LISTING
DeviceName:
DeviceProprietary/Brand Name:
Model/Reference Number/Property Code/Item Code:
Classiﬁcation:
ClassA ClassB ClassC ClassD
Intended UseofDevice:
Applicant’s Company Name:
Address:
TelNo. Fax.No. E-mailaddress:
Company Owner/General Manager:
Regulatory Ofﬁcer/Company Representative:
LegalManufacturer(Product Owner):
Address:
Manufacturing site:
Weherebycertifythattheforegoing information andallotherdatasubmitted inconnection withthisapplication
aretrueandcorrect.Weunderstand thatthefailuretoreportallrequiredinformation orsubmission offalseor
misleading information isanoffensepunishable bylaw.
25
Regulatory Officer:
SIGNATURE OVERPRINTED NAME
Government issuedIDNumber:
DateIssued:
PlaceofIssuance:
SUBSCRIBED ANDSWORN beforemethis
mehis/hergovernment issuedIDindicated above.Owner/General Manager:
SIGNATURE OVERPRINTED NAME
Government issuedIDNumber:
DateIssued:
PlaceofIssuance:
dayof afﬁantexhibiting to
NOTARY PUBLIC
26
ANNEX K:EXAMPLE OFAN
CHECKLISTESSENTIAL PRINCIPLES CONFORMITY
Essential PrincipleApplicable
tothe
device?Methodof
ConformityIdentityof
Speciﬁc
Documents
1.Medicaldevicesshouldbedesigned andmanufactured insuchawaythat,
whenusedundertheconditions andforthepurposes intendedand,where
applicable, byvirtueofthetechnical knowledge, experience, education or
trainingofintendedusers,theywillnotcompromise theclinicalcondition
orthesafetyofpatients, orthesafetyandhealthofusersor,where
applicable, otherpersons,provided thatanyriskswhichmaybeassociated
withtheiruseconstitute acceptable riskswhenweighed againstthe
beneﬁtstothepatientandarecompatible withahighlevelofprotection
ofhealthandsafety.Yes
2.Thesolutions adoptedbythemanufacturer forthedesignand
construction ofthedew'cesshouldconformtosafetyprinciples, taking
accountofthegenerally acknowledged stateoftheart.Inselecting the
mostappropriate solutions, themanufacturer shouldapplythefollowing
principles inthefollowing order:
0Identifyhazardsandtheassociated risksarisingfromthe
intendeduseandforeseeable misuse;
0Eliminate orreducerisksasfaraspossible(inherently safe
designandconstruction);
0Whereappropriate takeadequate protection measures
including alarmsifnecessary, inrelationtorisksthatcannotbe
eliminated,
0Informusersoftheresidualrisksduetoanyshortcomings of
theprotection measures adopted.Yes
3.Devicesshouldachievetheperformance intended bythemanufacturer
andbedesigned, manufactured andpackaged insuchawaythattheyare
suitableforoneormoreofthefunctions withinthescopeofthedeﬁnition
ofamedicaldeviceapplicable ineachjurisdiction.Yes
4.Thecharacteristics andperformances referredtoinClausesl,2and3
_shouldnotbeadversely affected tosuchadegreethattheclinical
conditions andsafetyofthepatientsand,whereapplicable, ofother
personsarecompromised duringthelifetimeofthedevice,asindicated by
themanufacturer, whenthedeviceissubjected tothestresseswhichcan
occurduringnormalconditions ofuseandhasbeenproperlymaintained
inaccordance withthemanufacturer’s instructions.Yes
5.Thedevicesshouldbedesigned, manufactured andpackedinsuchaway
thattheircharacteristics andperformances duringtheirintendedusewill
notbeadversely affectedduringtransport andstoragetakingaccountof
theinstructions andinformation provided bythemanufacturer.Yes
7.1Thedevicesshouldbedesigned andmanufactured insuchawayasto
ensurethecharacteristics andperformance referredtoinSection Iofthe
“General Requirements”. Particular attention shouldbepaidto:
oThechoiceofmaterials used,particularly asregardstoxicityand,
whereappropriate, ﬂammability,
0Thecompatibility between thematerials usedandbiological
tissues,cellsandbodyﬂuids,takingintoaccounttheintended
purposeofthedevice.
0Thechoiceofmaterials usedwhichshouldreﬂect,where
appropriate, matterssuchashardness, wearandfatiguestrength.
7.2Thedevicesshouldbedesigned, manufactured andpackedinsuchaway
astominimize theriskposedbycontaminants andresiduestothepersons
involved inthetransport, storageanduseofthedevicesandtothepatients,
takingaccountoftheintended purposeoftheproduct. Particular attention
shouldbepaidtothetissuesexposedandtothedurationandfrequency of
exposure
27