Page 69 - 2021 Taiwan Food and Drug Administration Annual Report
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In order to fulfill the framework of the convergence. This event also fully demon-
cooperation between Taiwan and Japan on strates the regulatory capacity of Taiwan in
PHGLFDO SURGXFWV UHJXODWLRQ WKH th Joint medical device review while facilitating the
Conference of Taiwan and Japan on Medical establishment of cooperative agreement and
Products Regulation was held by video con- mutual recognition. The AHWP TC WG2
IHUHQFLQJ RQ 2FWREHU DQG 5HS- led by Taiwan has produced a total of 12
resentatives of both sides shared experience international guidances related to in vitro di-
on the reviewing of COVID-19 diagnostic DJQRVWLF PHGLFDO GHYLFHV RYHU WKH \HDUV DQG
test kits and principles of medical device the results are considered fruitful. Taiwan’s
cybersecurity regulation. In-depth discus- H൵RUWV DQG FRQWULEXWLRQV WR WKH LQWHUQDWLRQDO
sions included topics such as the compari- harmonization of in vitro diagnostic medical
son results of medical device product items device regulations have been recognized in-
between Taiwan and Japan and subsequent ternationally. The hosting of or participation
collaboration direction of the medical device in AHWP related activities has intensified
Product Registration Working Group. The the harmonization of laws and regulations
Conference on International Medical Device DQG UHJLRQDO FROODERUDWLRQ DQG LQFUHDVHG H[-
Regulations was held online from October changes between Taiwan and countries of the
WR 1RYHPEHU ,QGXVWU\ DQG JRY- 1HZ 6RXWKERXQG 3ROLF\ ,Q DGGLWLRQ 7)'$
HUQPHQW UHSUHVHQWDWLYHV IURP WKH (8 7KDL- actively participates in biannual meetings
ODQG DQG 7DLZDQ ZHUH LQYLWHG WR H[FKDQJH and working group meetings of IMDRF to
information on the EU and ASEAN medical help expand Taiwan’s global visibility and
GHYLFH UHJXODWLRQV DUWLILFLDO LQWHOOLJHQFH participation level in important international
PHGLFDO GHYLFHV ULVN PDQDJHPHQW DQG VRIW- organizations. And by conducting annual
ware validation. Joint Conference of Taiwan and Japan on
0HGLFDO 3URGXFWV 5HJXODWLRQ 7)'$ FRQWLQ-
$FKLHYHPHQWV DQG %HQH¿WV ues to promote interaction and understand-
ing of regulatory information between both
For the APEC Medical Devices Regu- VLGHV VWUHQJWKHQ WKH FROODERUDWLRQ EHWZHHQ
latory Science Center of Excellence Work- LQGXVWU\ DQG JRYHUQPHQW DOLJQ ZLWK LQWHUQD-
VKRS KHOG LQ RYHUDOO VDWLVIDFWLRQ UDWH WLRQDO VWDQGDUGV DVVLVW WKH LQGXVWU\ WR GHSOR\
of trainees was 4.5 points (out of 5 points). LQWR LQWHUQDWLRQDO PDUNHWV DQG SURWHFW WKH
$ WRWDO RI WUDLQHHV IURP WKH JRYHUQPHQW public health and welfare. Years of case re-
LQGXVWU\ DQG DFDGHPLF VHFWRUV RI $3(& view and regulatory communication also en-
member economies participated. After the hance the mutual trust between both sides. It
FRPSOHWLRQ RI WUDLQLQJ WUDLQHHV ZRXOG EH is hoped that the product registration process
able to assist in promoting the concept of may be accelerated in the future to benefit
medical device standards to APEC mem- medical device manufacturers of both sides.
ber economies and help achieve regulatory
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