TAIWAN DOH ISSUES EMERGENCY EXTENSION FOR MEDICAL

UNCLAS TAIPEI 002731

SIPDIS

STATE FOR EAP/RSP/TC, STATE PASS USTR FOR WINELAND, WINTERS
AND FREEMAN, USDOC FOR 4431/ITA/MAC/AP/OPB/TAIWAN/MBMORGAN

E.O. 12958: N/A
TAGS: ECON ETRD TW
SUBJECT: TAIWAN DOH ISSUES EMERGENCY EXTENSION FOR MEDICAL
DEVICE IMPORTS

REF: TAIPEI 2626


1. The Taiwan Department of Health issued an administrative
notice on June 20 that allows the emergency importation of
medical devices for an additional six months. Medical device
manufacturers that have applied for registration of their
products but have not yet received licenses will be allowed
to continue to import their products until December 20, 2005.
Those manufacturers that did not apply for registration by
June 20, 2005 will not benefit from this amendment. Those
products that have been registered and have received import
licenses (as of June 17 barely 200 out of more than 4000
applications) can be imported without restriction. An
informal AIT translation of the relevant portion of the
announcement is below.


2. AIT informal translation of the relevant portion of the
DOH announcement: "The implementing regulations shall be
amended as follows: Article 4 -- The written application
shall be reviewed in accordance with agreed procedures, the
applicant having followed the relevant registration rules and
having paid the registration fee within the deadline
according to the relevant procedures.

"While awaiting the results of the review, the applicant
must, in accordance with the inspection result regulation,
pay the inspection fee within the deadline and at the same
time enclose all relevant information and necessary samples
in accordance with the inspection procedures.

"(amended) The competent Central Health Authority, due to the
public's critical need, after the application has been filed,
is able to issue a six month temporary permit."


3. Comment: The Department of Health told manufacturers and
AIT on June 17 that the administrative notice would allow the
continued importation of all medical devices that have
submitted registration applications but not yet received
licenses. An additional six months should give DOH ample
time to work through its backlog of applications. However,
given the slow pace of registration approvals DOH's ability
to avoid another snafu is far from certain. End Comment.
PAAL