medical device approvals in brazil
TRANSCRIPT
8/4/2019 Medical Device Approvals in Brazil
http://slidepdf.com/reader/full/medical-device-approvals-in-brazil 1/8
Lfc`goi Cfr`gf Oxx{aroiw `n
K{ot`i4 O [fr`fz onc Vxcosf
8/4/2019 Medical Device Approvals in Brazil
http://slidepdf.com/reader/full/medical-device-approvals-in-brazil 2/8
Lfc`goi Cfr`gf Oxx{aroiw `n K{ot`i4 O [fr`fz onc Vxcosf
xojf ;
Lfc`goi Cfr`gf Oxx{aroiw `n K{ot`i4O [fr`fz onc Vxcosf
Z`se o xaxvios`an ab la{f seon ?08 l`ii`an xfaxif onc o losv{f efoisego{f wpwsfl)
K{ot`i {fx{fwfnsw sef io{jfws lfc`goi fqv`xlfns lo{mfs n Wavse Olf{`go onc anf ab
sef io{jfws lo{mfsw n sef za{ic?. Lonvbogsv{f{w wffm`nj sa fuxonc sef`{ lo{mfs {foge
kp wfii`nj lfc`goi cfr`gfw n K{ot`i z`ii fngavnsf{ on frair`nj {fjviosa{p oxx{aroiw
wpwsfl) ngivc`nj loncosa{p cfr`gf {fj`ws{os`an. Kfgovwf sef K{ot`i`on lo{mfs
{fx{fwfnsw wvge o w`jn`gons axxa{svn`sp) lonvbogsv{f{w ab lfc`goi cfr`gfw gon
kfnfs b{al vncf{wsonc`nj kase sef {fjviosa{p {fqv`{flfnsw onc sef {fj`ws{os`an
onc gf{s`gos`an x{agfww ba{ sef`{ x{acvgsw.
Se`w VI ze`sf xoxf{ {fr`fzw K{ot`i‐w gv{{fns {fjviosa{p b{olfza{m ba{ lfc`goi
cfr`gfw) onc sef {fqv`{flfnsw ba{ seawf fns`s`fw wffm`nj sa lonvbogsv{f) lxa{s a{
wfii lfc`goi cfr`gfw `n sef gavns{p. @s oiwa c`wgvwwfw sef {fj`ws{os`an onc gf{s`gos`an
x{agfww {fqv`{fc ab oii cfr`gf lonvbogsv{f{w) lxa{sf{w onc c`ws{`kvsa{w) onc sef
wsfxw nfgfwwo{p sa wfgv{f onc lo`nso`n oxx{aroi ba{ lfc`goi cfr`gfw. Se`w ze`sf
xoxf{ ngivcfw nba{los`an an {fqv`{flfnsw bavnc n [CG ;:!@N,7 onc [fwaivs`an 768)xvki`wefc kp K{ot`i`on {fjviosa{p ovsea{`s`fw n Dvnf ;8??.
[fjviosa{p Kogmj{avnc
[fwaivs`an [CG Na. ?56 ab Agsakf{ ;;) ;88?; `w sef x{`lo{p {fjvios`an oxxi`gokif sa sef
{fj`ws{os`an ab oii lfc`goi cfr`gfw) fugfxs ba{ n r`s{a c`ojnaws`g %@RC cfr`gfw) ze`ge
o{f garf{fc kp [fwaivs`an [CG Na. ;82 ab Narflkf{ ;882. [CG Na. ?56 cfwg{`kfw sef
oxxi`gokif cfr`gf {fj`ws{os`an x{asagai onc i`wsw sef cagvlfnsw {fqv`{fc sa ifjoiip
{fj`wsf{ o lfc`goi cfr`gf n K{ot`i. Onnfu @@ ab [CG Na. ?56 cfwg{`kfw sef gioww`gos`an
ws{vgsv{f oxxi`gokif sa lfc`goi cfr`gfw) oww`jn`nj lfc`goi cfr`gfw sa anf ab bav{
c`ws`ngs {`wm giowwfw %@) @@) @@@ onc @R ogga{c`nj sa ?5 c`bbf{fns {vifw. Sef gioww`gos an
ws{vgsv{f ba{ lfc`goi cfr`gfw `n K{ot`i ga{{fwxancw sa seos vwfc n sef Fv{axfon Vn`an%FV vncf{ Gavng`i C`{fgs`rf 07!3;!FFG gangf{n`nj lfc`goi cfr`gfw.
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Lfc`goi Cfr`gf Oxx{aroiw `n K{ot`i4 O [fr`fz onc Vxcosf
xojf 7
K{ot`i `w o lflkf{ ab sef Wavsef{n
Gallan Lo{mfs) oiwa mnazn owLF[GAWV[) ze`ge ngivcfw sef gavns{`fw
ab O{jfns`no) Xo{ojvop onc V{vjvop. Ow
wvge) sef x{agfww ba{ sef {fj`ws{os`an ab
lfc`goi cfr`gfw `n K{ot`i eow kffn xo{s`oiip
eo{lan`tfc z`se seos ab sefwf gavns{`fw)
sefa{fs`goiip fow`nj sef x{agfww ab jo`n`nj
ocl`ww`an sa sefwf asef{ lo{mfsw.
ONR@WO [fj`ws{os`an X{agfww
Oii lfc`goi cfr`gfw `lxa{sfc `nsa a{
c`ws{`kvsfc z`se`n K{ot`i lvws {ws kf{fj`wsf{fc z`se sef Ojäng`o Nog`anoi
cf R`j`iëng`o Won`sï{`o) oiwa mnazn
ow ONR@WO a{ sef Nos`anoi Efoise
Wv{rf`iiongf Ojfngp. Fwsoki`wefc n
?0007 vncf{ K{ot`i‐w L`n`ws{p ab Efoise)
ONR@WO w on `ncfxfncfnsip ocl`n`wsf{fc)
nong`oiip ovsanalavw {fjviosa{p
ojfngp {fwxanw`kif ba{ sef {fjvios`an
onc arf{w`jes ab lfc`goi cfr`gfw
onc asef{ lfc`goi x{acvgsw n K{ot`i.
Wxfg`goiip) ONR@WO w {fwxanw`kif ba{ sef
{fj`ws{os`an ab lfc`goi cfr`gfw onc ba{
sef lo`nsfnongf ab o {fj`wsf{fc x{acvgsw
cosokowf3. Vni`mf sef FV Nas`fc
Kacp wpwsfl) sef 6?8%m wpwsfl ab sef
Baac onc C{vj Ocl`n`ws{os`an %BCO
`n sef Vn`sfc Wsosfw) a{ sef Gonoc`on
Lfc`goi Cfr`gf Ganba{l`sp Owwfwwlfns
Wpwsfl %GLCGOW) ONR@WO xf{ba{lw oii
{fj`ws{os`an onc nwxfgs`an bvngs`anw
z`se`n sef ojfngp.
Anip galxon`fw kowfc n K{ot`i gon
oxxip ba{ ONR@WO {fj`ws{os`an. Sef{fba{f)
galxon`fw kowfc fiwfzef{f seos ca nas
eorf wvkw`c`o{`fw `n K{ot`i lvws cfxfncan K{ot`i`on,kowfc se`{c xo{s`fw) wvge
ow eaws`nj galxon`fw) c`ws{`kvsa{w onc
cfoif{w) sa akso`n ONR@WO {fj`ws{os`an
ba{ lfc`goi cfr`gfw. Vncf{ wvge on
o{{onjflfns) sef iagoi se`{c xo{sp
eaicw sef ONR@WO {fj`ws{os`an) onc o
lonvbogsv{f{ lvws lo`nso`n on fbbfgs`rf
gallf{g`oi {fios`anwe`x z`se o se`{c xo{sp
sa fnwv{f sef anja`nj lo`nsfnongf ab o
{fj`ws{os`an. Asef{z`wf) o lonvbogsv{f{
z`ii nffc sa {fxfos sef {fj`ws{os`an
x{agfww z`se onasef{ iagoi se`{c xo{sp sa
lo`nso`n lo{mfs oggfww.
Sef {fj`ws{os`an ab laws Gioww ? onc ;
cfr`gfw nrairfw o {fios`rfip w`lxif
oxxi`gos`an x{agfww ‗ {fbf{{fc sa ow
’gocows{a)“ lfon`nj ’okk{fr`osfc
{fj`ws{os`an“ ‗ kowfc an sef iaz sa
lacf{osf {`wm owwag`osfc z`se cfr`gfw
`n sefwf giowwfw. Eazfrf{) kowfc an sef
j{fosf{ cfj{ff ab {`wm owwag`osfc z`sesef`{ vwf) o la{f {`ja{avw x{agfww oxxi`fw
sa walf Gioww ? onc Gioww ; lfc`goi
cfr`gfw) ow zfii ow oii Gioww 7 onc Gioww 3
cfr`gfw. @n sefwf gowfw) sef xo{sp oxxip`nj
ba{ ONR@WO {fj`ws{os`an lop kf {fqv`{fc
sa x{ar`cf walf a{ oii ab sef baiiaz`nj
cagvlfnsos`an z`se on oxxi`gos`an)
cfxfnc`nj an sef cfr`gf geo{ogsf{`ws`gw
onc gioww`gos`an4
?. B{ff woifw gf{s`gosf %`s gon
kf {fxiogfc kp sef @NLFS[A
gf{s`gosf zefn oxxi`gokif
;. Gf{s`gosf ab Jaac Lonvbogsv{`nj
X{ogs`gf %JLX
7. @nws{vgs`anw lonvoi `n Xa{svjvfwf
3. Iokfi`nj onc xogmoj`nj
6. Ifssf{ b{al sef cfr`gf
lonvbogsv{f{) ovsea{`t`nj o
K{ot`i`on galxonp sa eaic sef
x{acvgs {fj`ws{os`an onc c`ws{`kvsf
o cfr`gf
2. Gi`n`goi s{`oiw %walfs`lfw s gon
kf {fxiogfc kp sef @NLFS[A
gf{s`gos`an a{ i`sf{osv{f x{ar`njsef fbbfgs`rfnfww ab sef cfr`gf
:. I`ws ab oii cfr`gf oggfwwa{`fw
5. Ba{ walf cfr`gfw) wvge ow
`lxionsokif lfc`goi cfr`gfw)
go{c`arowgvio{ x{acvgsw) e`je,{`wm
@RCw) c`oipw`w fqv`xlfns onc
xf{wanoi efo{`nj o`c wpwsflw) on
Fganal`g @nba{los`an [fxa{s
0. @NLFS[A gf{s`gosf)
zefn oxxi`gokif
Sef galxifsf wfs ab cagvlfnsos`an
cfxfncw an sef nosv{f ab sef cfr`gf) f.j.)
@RC cfr`gfw) lxionsw) fifgs{a,lfc`goi
cfr`gfw) fsg. Cfn`nj sef fuogs xogmojf
ab cagvlfnsos`an w o galxifu x{agfww)
onc {fqv`{fw ganwvis`nj ro{`avw iozw
onc cfg{ffw %Ioz 27284?0:2) [CG Na.
?564;88? onc [CG Na. 604;888. Sef
cagvlfnsos`an i`ws okarf oxxi`fw sa sef
loda{`sp ab lfc`goi cfr`gfw= `n x{ogs`gf)eazfrf{) {fqv`{fc cagvlfnsos`an gon kf
lvge la{f fusfnw`rf.
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Lfc`goi Cfr`gf Oxx{aroiw `n K{ot`i4 O [fr`fz onc Vxcosf
xojf 3
JLX @nwxfgs`an
onc Gf{s`bgos`anJLX gf{s`gos`an kowfc an on nwxfgs`an
gancvgsfc kp ONR@WO w {fqv`{fc ba{
{fj`ws{os`an %[CG Na. ;6) Lop ;?) ;880.
Sef JLX gf{s`gosf lvws kf wvkl`ssfc
z`se sef {fj`ws{os`an oxxi`gos`an ba{ oii
Gioww @@@ onc @R cfr`gfw) ow zfii ow ba{ Gioww
@ onc @@ cfr`gfw nasfc an sef Fuflxs`an
I`ws %@nws{vgs`an @N,;) Dvnf 2) ;8??. JLX
`nwxfgs`anw o{f oiwa {fqv`{fc sa {froi`cosf
a{ vxcosf fu`ws`nj {fj`ws{os`anw. Sef
JLX gf{s`gosf w roi`c ba{ sza pfo{w)
onc ONR@WO oianf cfsf{l`nfw zefsef{
wvkwfqvfns froivos anw gon kf galxifsfc
{flasfip se{avje o xoxf{za{m ovc`s. Sef
oxxi`gos`an ba{ JLX weavic ganso`n sef
baiiaz`nj cagvlfnsos`an4
• Cfr`gf cfwg{`xs`an onc `nc`gos an
ab {`wm gioww
• Galxifsf az geo{s cfwg{`k`nj
sef {fios`anwe`x z`se se`{c,xo{sp
lonvbogsv{f{w) b onp
• Xoplfns {fgf xs ba{ sef JLX
`nwxfgs`an bff
• Sef JLX nwxfgs`an gefgm ba{
galxi`ongf z`se [CG Na. 60
@NLFS[A Gf{s`bgos`an X{agfww
K{ot`i‐w @nws`svsa Nog`anoi cf Lfs{aiaj`o)
Na{loi`toêça f _voi`cocf @ncvws{`oi)
oiwa mnazn ow @NLFS[A a{ sef Nos`anoi
@nws`svsf ab Lfs{aiajp) Wsonco{c`tos`anonc @ncvws{`oi _voi`sp) w sef kacp
{fwxanw kif ba{ ogg{fc`s`nj gf{s`gos`an
a{jon`tos`anw seos gf{s`bp x{acvgsw ba{galxi`ongf z`se oxxi`gokif {fqv`{flfnsw
onc ovsea{`tf sef vwf ab oxx{arfc
gf{s`gos`an lo{mw. Se`w gf{s`gos`an
wgeflf `w mnazn ow sef K{ot`i`on
Ganba{l`sp Owwfwwlfns Wpwsfl %WKOG.
VI eow kffn ogg{fc`sfc kp @NLFS[A
sa froivosf onc sfws x{acvgsw) cfr`gfw)
fqv`xlfns) losf{`oi) x{agfwwfw onc
wf{r`gfw ba{ galxi`ongf z`se sef
wsonco{cw {fgajn`tfc kp WKOG.
Sa qvoi`bp ba{ @NLFS[A gf{s`gos`an)
lfc`goi cfr`gf lonvbogsv{f{w lvws eorf
sef`{ x{acvgsw sfwsfc sa WKOG,{fgajn`tfc
wsonco{cw kp on @NLFS[A,ogg{fc`sfc
sfws`nj ioka{osa{p. Sef Owwag`oêça
K{ow`if`{o cf Na{low Sàgn`gow) oiwa
mnazn ow OKNS a{ sef K{ot`i`on
Owwag`os`an ba{ Sfgen`goi Wsonco{cw)
`w {fwxanw`kif ba{ sef oxx{aroi ab oii
wsonco{cw onc ba{ sef oxxi`gos`an ab onp
nos`anoi cfr`os`anw) spx`goiip i`l`sfc sa
s{onwios`an ab o wsonco{c `nsa Xa{svjvfwf.
OKNS oxx{arfc wsonco{cw o{f jfnf{oiip
x{fgfcfc kp on NK[ cfw`jnos`an.
Ganw`wsfns z`se sef {fqv`{flfnsw ab
[CG Na. ;: onc @N,7 xvki`wefc `n Dvnf
;8??) oii lfc`goi cfr`gfw waic `n K{ot`i
seos boii vncf{ sef wgaxf ab sef baiiaz`nj
wsonco{cw lvws kf @NLFS[A gf{s`fc4
• NK[ @FG 2828? wf{`fw
• NK[ @WA 25:64?0054
Cfnsoi xos`fns geo`{
• NK[ @WA ::56,?4?0004
Cfnsoi eoncx`fgfw ‗ Xo{s ?4E`je,wxffc o`{ sv{k`nf eoncx`fgfw
• NK[ @WA ::56,;4;8834
Cfnsoi eoncx`fgfw ‗
Xo{s ;4 Ws{o`jes onc jfo{fc
onjif eoncx`fgfw
• NK[ @WA 02584;88?4
Cfns`ws{p , Axf{os`nj i`jesw
• NK[ @WA 00?04?00:4 Lfc`goi
fifgs{`goi fqv`xlfns ‗ Xo{s`gvio{
{fqv`{flfnsw ba{ sef kow`g wobfsponc fwwfns`oi xf{ba{longf ab
xviwf au`lfsf{ fqv`xlfns ba{
lfc`goi vwf
• NK[ @WA ???064;8884 Jow l`uf{w
ba{ lfc`goi vwf ‗ Wsonc,oianf
jow l`uf{w
• NK[ @WA 5576,;4;8?84 @neoios`anoi
onofwsefw o wpwsflw ‗ Xo{s ;4
Onofwsefs`g k{fose`nj wpwsflw
• NK[ @FG 2?2504?0054 Vis{owan`gw
‗ Xepw`asef{oxp wpwsflw ‗ B`fic
wxfg`gos`anw onc lfseacw ab
lfowv{flfns `n sef b{fqvfngp
{onjf 8.6 LEt sa 6 LEt
@lxa{sonsip) vncf{ [CG Na. ;: onc
@nws{vgs`an @N,7) sef se`{c fc`s`an ab @FG
2828?,? w naz oggfxsokif `n K{ot`i ba{
@NLFS[A gf{s`gos`an. Se`w w o w`jn`gons
geonjf b{al [GC Na. 7; seos al`ssfc
sef se`{c fc`s`an ab @FG 2828?,? b{al sefK{ot`i`on gf{s`gos`an wgeflf.
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Lfc`goi Cfr`gf Oxx{aroiw `n K{ot`i4 O [fr`fz onc Vxcosf
xojf 6
Wsfxw sa @NLFS[A Gf{s`bgos`an
Angf o lfc`goi cfr`gf eow kffn sfwsfc sa sef {fqv`{flfnsw ab sef oxx{ax{`osf sfgen`goi
wsonco{c onc oii vwf{ lonvoiw eorf kffn s{onwiosfc `nsa Xa{svjvfwf) on oxxi`gons gon
x{agffc z`se sef @NLFS[A gf{s`gos`an x{agfww. Sef @NLFS[A,ogg{fc`sfc gf{s`gos`an
kacp z`ii sefn gancvgs sef wsfxw cfwg{`kfc n sef baiiaz`nj wfgs`anw.
?4 Cagvlfnsos`an Onoipw`w
B`{ws) sef gf{s`gos`an kacp z`ii {fr`fz sef x{acvgs cagvlfnsos`an) ganw`ws`nj ab
sef baiiaz`nj4
• Vwf{ lonvoiw s{onwiosfc `nsa Xa{svjvfwf
• _voi`sp lonvoi onc lowsf{ gans{ai i`ws ab o lonvbogsv{f{‐w qvoi`sp
lonojflfns wpwsfl• Walf gf{s`gos`an ojfng`fw z`ii oggfxs o lonvbogsv{f{‐w sfws {fxa{sw) wvge ow
@FGFF GK Wgeflf sfws {fxa{sw) seos eorf kffn wwvfc z`se`n sef xows sza pfo{w.
Asef{ sfws seos o{f oggfxsokif sa o z`cf{ {onjf ab gf{s`gos`an ojfng`fw ngivcf
{fxa{sw wwvfc kp a{jon`tos`anw ogg{fc`sfc kp w`jnosa{`fw ab sef @nsf{nos`anoi
Ioka{osa{p Ogg{fc`sos`an Gaaxf{os`an %@IOG) ngivc`nj sef Olf{`gon Owwag`os`an
ba{ Ioka{osa{p Ogg{fc`sos`an %O;I O onc sef V.W. Nos`anoi Raivnso{p Ioka{osa{p
Ogg{fc`sos`an X{aj{ol %NRIOX.
• @b o cfr`gf {flo`nw vngeonjfc w`ngf sef sfws {fxa{sw zf{f a{`j`noiip `wwvfc)
o lonvbogsv{f{ weavic x{ar`cf o cfgio{os`an sa seos fbbfgs
Sef gf{s`gos`an kacp z`ii {fr`fz sef sfws {fxa{sw sa owwfww zefsef{ o lfc`goi cfr`gfeow kffn galxifsfip froivosfc sa oii oxxi`gokif wsonco{cw) ngivc`nj gaiiosf{oi onc
xo{s`gvio{ wsonco{cw) onc galxifsf onp occ`s`anoi sfwsw seos l`jes kf {fqv`{fc.
Cv{`nj se`w onoipw w) sef gf{s`gos`an kacp lop oiwa g{fosf o if seos ganso`nw
sfgen`goi nba{los an okavs o cfr`gf) ngivc`nj o i`ws ab g{`s`goi galxanfnsw. Zefn sef
gf{s`gos`an kacp w wos`wfc seos o x{acvgs galxi`fw z`se oxxi`gokif {fqv`{flfnsw)
o x{f,i`gfnwf `nwxfgs`an `w xf{ba{lfc.
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Lfc`goi Cfr`gf Oxx{aroiw `n K{ot`i4 O [fr`fz onc Vxcosf
xojf 2
;4 X{f,I`gfnwf @nwxfgs`an
Se`w bogsa{p nwxfgs`an w w`l`io{ sa
GFNFIFG‐w Gallan @nsf{fws J{avx
%G@J ;7 qvoi`sp `nwxfgs`an. Sef wgaxf
ab sef x{f,i`gfnwf nwxfgs`an `ngivcfw
rf{`gos`an ab galxi`ongf z`se sef
baiiaz`nj giovwfw ab @WA ?73564;8874
3.;.74 Gans{ai ab cagvlfnsw
3.;.34 Gans{ai ab {fga{cw
:.?4 Xionn`nj ab x{acvgs {foi`tos`an
:.;.74 Gvwsalf{ gallvn`gos`an
:.7.24 Cfw`jn onc cfrfiaxlfns roi`cos`an
:.7.:4 Gans{ai ab cfw`jn onc
cfrfiaxlfns geonjfw
:.3.74 Rf{`gos`an ab xv{geowfc x{acvgs
:.6.?4 Gans{ai ab x{acvgs`an onc
wf{r`gf x{ar`w`an
:.6.;4 Roi`cos`an ab x{agfwwfw ba{
x{acvgs`an onc wf{r`gf x{ar`w`an
:.6.74 @cfns`gos`an onc s{ogfok`i`sp
:.6.64 X{fwf{ros`an ab x{acvgs
:.24 Gans{ai ab lan`sa{`nj onc
lfowv{`nj cfr`gfw
5.;.74 Lan`sa{`nj onc lfowv{flfns
ab x{agfwwfw
5.;.3 4 Lan`sa{`nj onc lfowv{flfns
ab x{acvgs
5.74 Gans{ai ab nanganba{l`nj x{acvgs
5.6.;4 Ga{{fgs`rf ogs`an
@n occ`s`an sa sef @WA giovwfw okarf)
on ovc`sa{ gancvgs`nj o x{f,i`gfnwf
`nwxfgs`an z`ii iaam ba{ fr`cfngf seos
sef baiiaz`nj x{acvgs`an sfwsw o{f kf`nj
xf{ba{lfc kp o lonvbogsv{f{ an ?88&
ab seawf lfc`goi cfr`gfw kfo{`nj sef
@NLFS[A lo{m4
• Ifomojf gv{{fns
%fo{se) fngiawv{f) xos`fns
%Giovwf ?0 ab @FG 2828?,?
• Fo{se`nj
%x{asfgs`rf!bvngs`anoi onc
xasfns`oi fqvoi`tos`an
%Giovwf ?5 ab @FG 2828?,?
• C`fifgs{`g ws{fnjse
%Giovwf ;8 ab @FG 2828?,?
• Bvngs`anoi sfws74 Gf{s`bgos`an onc X{acvgs Lo{m`nj
Obsf{ o gf{s`gos`an kacp eow
galxifsfc `sw {fr`fz ab sfws {fxa{sw
onc vwf{ lonvoiw ow zfii ow `sw
x{f,i`gfnwf bogsa{p nwxfgs`an onc eow
cfsf{l`nfc seos o cfr`gf onc sef cfr`gf
lonvbogsv{f{ o{f galxi`ons z`se oii
oxxi`gokif {fqv`{flfnsw) sef gf{s`gos`ankacp wwvfw on @NLFS[A gf{s`gosf.
On @NLFS[A gf{s`gosf w roi`c ba{ rf
pfo{w) onc fr`cfngf ab sef gf{s`gos`an
`w xvki`wefc n @NLFS[A‐w c`{fgsa{p ab
oxx{arfc x{acvgsw. @n occ`s`an) fr`cfngf
ab gf{s`gos`an lop oiwa kf xvki`wefc kp
sef gf{s`gos`an kacp `n `sw azn c`{fgsa{p
ab oxx{arfc x{acvgsw.
Os sef fnc ab o gf{s`gos`an x{agfww)
on oxxi`gons `w ovsea{`tfc sa vwf
gf{s`gos`an lo{mw sa cflanws{osf o
cfr`gf‐w galxi`ongf %fuolxifw ab lo{mw
`wwvfc kp VI o{f weazn n B`jv{f ?.
Sefwf lo{mw weavic kf xiogfc an kase
sef oxx{arfc lfc`goi cfr`gf onc an sef
x{acvgs xogmoj`nj. Sef a{onjf,gaia{fc)
{fgsonjvio{ lo{m weavic kf o l`n`lvl
ab 68 ll n w`tf. Sef kiogm onc ze`sf
lo{mw z`se sef za{c`nj @NLFS[A onc
AGX,88;0 weavic kf os ifows ;; ll. Sef
wloiifws lo{m z`se sef za{c WFJV[ONÊO
weavic kf os ifows ?? ll. Sefwf sza
wloiif{ lo{mw o{f vwfc anip n gowfw
zef{f sef{f w nwvbg`fns wxogf ba{ sef
io{jfws {fgsonjvio{ lo{m. Sef gf{s`gos`an
kacp weavic x{ar`cf `nws{vgs`anw ba{
oxx{ax{`osf vwf ab sef gf{s`gos`an lo{mw
ow zfii ow o{sza{m ba{ x{`ns`nj xv{xawfw.
B`jv{f ?4 @NLFS[A Gf{s`gos`an Lo{mw
8/4/2019 Medical Device Approvals in Brazil
http://slidepdf.com/reader/full/medical-device-approvals-in-brazil 7/8
Lfc`goi Cfr`gf Oxx{aroiw `n K{ot`i4 O [fr`fz onc Vxcosf
xojf :
Onnvoi @nwxfgs`an
I`mf laws asef{ x{acvgs gf{s`gos`an
wpwsflw) lo`nso`n`nj on @NLFS[A
gf{s`gos`an {fqv`{fw gf{so`n xf{`ac`g
ogs`r`s`fw. Ba{ on oxx{arfc lfc`goi
cfr`gf sa {flo`n @NLFS[A gf{s`fc ba{
sef bvii rf pfo{ gf{s`gos`an xf{`ac)
o lonvbogsv{f{‐w bog`i`sp w wvkdfgs sa
onnvoi wv{rf`iiongf nwxfgs`anw. On
onnvoi @NLFS[A `nwxfgs`an weavic somf
xiogf oxx{au`losfip ?; lansew obsf{ sef
a{`j`noi gf{s`gos`an eow kffn wwvfc onc
os wvggffc`nj ?; lanse `nsf{roiw ba{ sef
cv{os`an ab sef gf{s`gos`an xf{`ac. Ba{
fuolxif) ba{ o gf{s`gos`an a{`j`noiip
`wwvfc `n Narflkf{ ;8?8) sef {ws
onnvoi wv{rf`iiongf nwxfgs`an zavic kf
gancvgsfc o{avnc Narflkf{ ;8??) onc
ojo`n `n Narflkf{ ;8?;) Narflkf{ ;8?7
onc Narflkf{ ;8?3.
Zefn o gf{s`gos`an kacp eow iagoiip
qvoi`fc wsobb onc bog`i`s`fw) sef onnvoi
@NLFS[A wv{rf`iiongf nwxfgs`anw gon kf
gancvgsfc kp iagoi owwfwwa{w. Sef wgaxf
ab sefwf onnvoi lo`nsfnongf `nwxfgs`anw
`w sef wolf ow sef x{f,i`gfnwf nwxfgs`an
gancvgsfc os sef kfj`nn`nj ab sef
gf{s`gos`an x{agfww.
[fgf{s`bgos`an
Ow x{fr`avwip lfns`anfc) sef @NLFS[A
gf{s`gosf `w roi`c ba{ o xf{`ac ab rf
pfo{w) obsf{ ze`ge o cfr`gf lvws kf
{fgf{s`fc. @b o gf{s`gosf eaicf{ z`wefw
sa {fnfz o lfc`goi cfr`gf gf{s`gos`an ba{occ`s`anoi rf pfo{ sf{l) o cfr`gf nffcw
sa kf bviip {fsfwsfc kp onp ioka{osa{p okif
sa `wwvf GK Sfws [fxa{sw a{ seos `w @IOG
ogg{fc`sfc. O cfr`gf nffcw sa kf {fsfwsfc
frfn `b `sw cfw`jn `w vngeonjfc w`ngf sef
`n`s`oi x{acvgs oxx{aroi.
Asef{ @wwvfw onc Gangf{nw
Laws wobfsp gf{s`gos`anw x{ar`cf
sfws`nj sa o kowf wsonco{c onc oxxi`gokif
xo{s`gvio{ wsonco{cw. ONR@WO {fqv`{fw
x{acvgsw sa kf sfwsfc sa laws ab sef
xo{s`gvio{ onc gaiiosf{oi wsonco{cw)`ngivc`nj @FG 2828?,?,; %FLG onc @FG
2828?,?,3 %wabszo{f.
Galxon`fw seos ca nas galxip z`se
sef oxx{aroi {fqv`{flfnsw ba{ lfc`goi
cfr`gfw gon bogf wfrf{f xfnois`fw) b{al
nong`oi owwfwwlfnsw sa sef ganwgos`an
ab vnoxx{arfc x{acvgsw. Gvwsalw
abg`oiw n K{ot`i z`ii anip ovsea{`tf sef
`lxa{sos`an ab x{acvgsw obsf{ ganwvis`nj
z`se ONR@WO‐w oxx{arfc x{acvgsw
cosokowf sa fnwv{f seos o x{acvgs eow
kffn x{axf{ip {fj`wsf{fc. @n gowf ab
cavks) gvwsalw abg`oiw z`ii spx`goiip
eaic oii x{acvgsw os on aznf{‐w fuxfnwfvns`i {fj`ws{os`an onc gf{s`gos`an gon
kf rf{`fc.
8/4/2019 Medical Device Approvals in Brazil
http://slidepdf.com/reader/full/medical-device-approvals-in-brazil 8/8
Lfc`goi Cfr`gf Oxx{aroiw `n K{ot`i4 O [fr`fz onc Vxcosf
xojf 5
Gangivw`an
Sef gv{{fns w`tf onc ons`g`xosfc gans`nvfc j{azse ab sef K{ot`i`on lo{mfs x{fwfnsww`jn`gons axxa{svn`s`fw ba{ lonvbogsv{f{w ab lfc`goi cfr`gfw. K{ot`i‐w {fjviosa{p
oxx{aroi wgeflf ba{ lfc`goi cfr`gfw `w w`l`io{ sa seos bavnc `n asef{ gavns{`fw. @n
occ`s`an) K{ot`i {fi`fw an nos`anoi rf{w`anw ab z`cfip oggfxsfc nsf{nos`anoi wsonco{cw
sa owwfww x{acvgs galxi`ongf.
Cfwx`sf sefwf w`l`io{`s`fw) sef ifnjse ab s`lf kfszffn i`nj on oxxi`gos`an ba{ o
{fj`ws{os`an ab o lfc`goi cfr`gf onc sef noi jarf{nlfns oxx{aroi gon kf ifnjsep.
Sef @nsf{nos`anoi S{ocf Ocl`n`ws{os`an ab sef V.W. Cfxo{slfns ab Gallf{gf fws`losfw
seos s gon somf ow i`ssif ow se{ff lansew a{ ow ianj ow sza pfo{w sa oge`frf x{acvgs
{fj`ws{os`an) cfxfnc`nj an sef spxf ab wvkl`ww`an sa ONR@WO) `.f.) nfz {fj`ws{os`an)
vxcosf a{ {froi`cos`an.6
Lfc`goi cfr`gf lonvbogsv{f{w gon fowf sef x{agfww ab jo`n`nj oggfww sa se`w ivg{os`rf
lo{mfs kp vncf{wsonc`nj sef w`l`io{`s`fw onc c`bbf{fngfw kfszffn K{ot`i‐w lfc`goi
cfr`gf oxx{aroi wgeflf onc sef wgeflfw vwfc `n asef{ loda{ lo{mfsw. Wsop`nj
`nba{lfc ab ons`g`xosfc geonjfw n {fjvios`anw gon x{ar`cf roivokif s`lf sa cfrfiax
oisf{nos`rf xionw onc ws{osfj`fw ba{ jo`n`nj onc lo`nso`n`nj lo{mfs oggfww. B`noiip)
za{m`nj z`se on fuxf{`fngfc onc mnazifcjfokif ogg{fc`sfc gf{s`gos`an kacp n
K{ot`i wvge ow VI gon wlaase sef galxi`ongf x{agfww onc l`s`josf wfskogmw b{al
vnons`g`xosfc `wwvfw onc geoiifnjfw.
Ba{ la{f `nba{los`an okavs sef ’Oxx{aroi ab Lfc`goi Cfr`gfw `n K{ot`i“ ze`sf xoxf{)
xifowf gansogs So{o Molkf`st) jiakoi lo{mfs`nj lonojf{ ‗ Efoise Wg`fngfw os
So{o.I.Molkf`stHvw.vi.gal.
VI onc sef V I iaja o{f s{ocflo{mw ab Vncf{z{`sf{w Ioka{osa{`fw @ng. ;8??.
Gaxp{`jes;8?? Vncf{z{`sf{w Ioka{osa{`fw @ng. Oii {`jesw {fwf{rfc. Na xo{s ab se`w cagvlfns lop kf gax`fc a{ c`ws{`kvsfc z`seavs sef
x{`a{ z{`ssfn ganwfns ab Vncf{z{`sf{w Ioka{osa{`fw @ng. :!??
SE@W CAGVLFNS @W X[AR@CFC BA[ @N BA[LOS@ANOI XV[XAWFW ANIP ONC @W NAS @ NSFNCFC SA GANRFP ONP IFJOI OCR@GF.
VWF AB SEF @NBA[LOS@AN @N SE@W CAGVLFNS @W OS PAV[ AZN [@WM. XIFOWF GANWVIS Z@SE IFJOI GAVNWFI BA[ OCR@GF AN
GALXIP@NJ Z@SE SEF [FJVIOS@ANW CFWG[@KFC OKARF.
? V.W. Cfxo{slfns ab Gallf{gf) @nsf{nos`anoi S{ocf Ocl`n`ws{os`an) ’Efoisego{f Sfgenaiaj`fw [fwav{gf Jv`cf ‗ O [fbf{fngf
ba{ VW Fuxa{sf{w sa Za{ic Lo{mfsw)“ ;880,;8?8 fc`s`an.; K{ot`i [fwaivs`an [CG Na. ?56 ) Agsakf{ ;;) ;88?) essx4!!zzz.onr`wo.jar.k{!ifj`w!{fwai!;88?!?56Q8?{cg.esl
%iows oggfwwfc an Dvnf ?8) ;8??.7 zzz.onr`wo.jar.k{!fnj!ifj`w!iozQ0:5;.esl
3 O bvii cfwg{`xs`an ab ONR@WO‐w ws{vgsv{f onc {fwxanw`k`i`s`fw w oro`iokif os essx4!!zzz.onr`wo.jar.k{!fnj!`nws`svs`an!`ncfu.esl %iowsoggfwwfc an Dvnf ??) ;8??.
6 ’Lfc`goi Cfr`gf [fjviosa{p [fqv`{flfnsw ba{ K{ot`i) @nsf{nos`anoi S{ocf Ocl`n`ws{os`an)“ V.W. Cfxo{slfns ab Gallf{gf) vxcosfc
Lo{ge ;8??) essx4!!zzz.`so.cag.jar!sc!efoise!k{ot`ilcx{aif.xcb %iows oggfwwfc an Dvnf ?8) ;8??.