US embassy cable - 05TAIPEI2731

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