Page 82 - 2019食藥署年報(英文版)

:FBS :FBS :FBS :FBS
5IF ESBGU PG UIF MFHBM GSBNF 5IF ESBGU PG UIF MFHBM GSBNF .BSDIJOH JOUP UIF MFHJTMBUJPO -FHBM JOTUJUVUJPO QSPDFEVSF
XPSL XBT DPNQMFUFE XPSL XBT DPNQMFUFE QSPDFTT
h 5IF BTTFTTNFOU PO UIF JOTUJUVUJPO PG UIF h 0QJOJPOT GSPN UIF -FHBM "GGBJST h 5IF 850 XBT OPUJGJFE h 5IF -FHBM "GGBJST
MFHBM GSBNFXPSL GPS NBOBHFNFOU PG 6OJUT WBSJPVT NJOJTUSJFT BOE PG UIJT ESBGU *U IBT CFFO SFWJFXFE #VSFBV VOEFS UIF -FHJTMBUJWF
NFEJDBM EFWJDFT XBT MBVODIFE EFQBSUNFOUT JO UIF &YFDVUJWF CZ UIF 850 NFNCFS TUBUFT UP :VBO BTTFTTFE UIF TFTTJPOT PG
h 5IF SFMFWBOU MBXT BOE SFHVMBUJPOT :VBO QVCMJD IFBMUI CVSFBVT JO BWPJE UFDIOJDBM CBSSJFST UP USBEF TFNJOBST
DPODFSOJOH UIF NBOBHFNFOU PG NFEJDBM UIF MPDBM HPWFSONFOUT BOE 5#5 h 4FTTJPOT GPS FMBCPSB
EFWJDFT GSPN WBSJPVT DPVOUSJFT XFSF QVCMJD BTTPDJBUJPOT XFSF DPMMFDU h TFTTJPOT PG FMBCPSBUJPO PO UIF UJPO PG UIF ESBGU XFSF IFME "
SFGFSFODFE BOE UIF SFMFWBOU BSUJDMFT FE UP SFDUJGZ UIF MFHBMJUZ PG UIF ESBGU XFSF IFME JOEVTUSJBMJTUT UPUBM PG BQQSPY SFQSFTFOUB
DPODFSOJOH NFEJDBM EFWJDFT JO UIF SFMFWBOU BSUJDMFT JO UIF ESBGU TJHOFE VQ GPS UIF TFTTJPOT UJWFT GSPN UIF QVCMJD IFBMUI
1IBSNBDFVUJDBM "GGBJST "DU XFSF JODPSQP h TFTTJPOT GPS DPNNVOJDBUJPO h 5IF ESBGU XBT TVCNJU CVSFBVT NFEJDBM EFWJDF JOEVT
SBUFE UP DPNQMFUF UIF ESBGU XJUI UIF QVCMJD XFSF IFME UFE UP UIF -FHBM "GGBJST $PNNJU USZ QVCMJD BTTPDJBUJPOT PG
h 5IF FYQFSUT JO WBSJPVT GJFMET QVCMJD IFBMUI h "EESFTTFFT WBSJPVT NJOJTUSJFT UFF VOEFS UIF .JOJTUSZ PG )FBMUI IPTQJUBMT BOE -FHJTMBUJWF :VBO
CVSFBVT JO UIF MPDBM HPWFSONFOUT BOE BOE EFQBSUNFOUT JO UIF &YFDV BOE 8FMGBSF GPS SFWJFX KPJOFE UIPTF TFTTJPOT
SFQSFTFOUBUJWFT PG UIF QVCMJD BTTPDJB UJWF :VBO QVCMJD IFBMUI CVSFBVT h 5IF ESBGU XBT TVCNJU h 5IJT ESBGU DPNQMFUFE
UJPOT XFSF JOWJUFE UP FMBCPSBUF UIF JO UIF MPDBM HPWFSONFOUT QVCMJD UFE UP UIF &YFDVUJWF :VBO GPS UIF BSUJDMF CZ BSUJDMF EFMJCFSBUJPO
QPMJDZ BTTPDJBUJPOT BOE FYQFSUT JO MBX SFWJFX h 5IF ESBGU BDU JT
h TFTTJPOT XFSF IFME XIFSF FYQFSUT DPVME h %FDFNCFS 5IF ESBGU XBT h 5IF -FHJTMBUJWF :VBO QBTTFE UIF JOUFS QBSUZ OFHPUJB
DPNNVOJDBUF XJUI QFPQMF XIP DBSFE SFMFBTFE GPS GFFECBDL GSPN UIF XBT OPUJGJFE UP SFWJFX UIF ESBGU UJPO JO -FHJTMBUJPO :VBO
BCPVU UIJT JTTVF QVCMJD h 5IF GJSTU SFBEJOH XBT
QBTTFE

'JHVSF cc 5IF QSPDFTT PG UIF QSPNPUJOH UIF Draft Medical Device Act

* *NQMFNFOUBUJPO .FBTVSFTNQMFNFOUBUJPO .FBTVSFT

The "Draft Medical Device Act" was released to the public for feedback on December 5,
DQG VXEPLWWHG WR WKH :72 RQ -DQXDU\ IRU SUHYLHZ WR DYRLG WHFKQLFDO EDUULHUV WR
trade (TBT). The Legislative Yuan was served with the "Draft Medical Device Management Act"
RQ 'HFHPEHU IRU UHYLHZ DQG UHVROXWLRQ DQG WKH ¿UVW UHDGLQJ SURFHGXUH ZDV FRPSOHWHG
RQ 'HFHPEHU 2Q 2FWREHU WKH DUWLFOHV KDYH EHHQ UHYLHZHG DUWLFOH E\ DUWLFOH
On December 14, 2018, the inter-party negotiation were completed (Figure 5-1). It is hoped the
domestic medical device management system can be improved through the establishment of the
Medical Device Act.

3FMFWBOU 'PDVTFT JO UIF %SBGU

In the whole-new "Draft Medical Device Act," the most important part includes adopting
the electronic online registration system for some low-risk medical devices, simplifying the pre-
market application process and implementing product risk management. Professionals engaged
in medical device design, such as academic researchers and software developers, can apply

for a license in their own names. This will increase the willingness of the industry/academy/

80