US embassy cable - 05TAIPEI4396

C O N F I D E N T I A L SECTION 01 OF 02 TAIPEI 004396 
 
SIPDIS 
 
STATE FOR EAP/RSP/TC AND EB/TPP/BTA, STATE PASS AIT/W AND 
USTR, USTR FOR WINELAND AND WINTERS, USDOC FOR 
4431/ITA/MAC/AP/OPB/TAIWAN/MBMORGAN 
 
E.O. 12958: DECL: 10/27/2015 
TAGS: ETRD, ECON, TW 
SUBJECT: MEDICAL DEVICE REGISTRATIONS FACE DECEMBER DEADLINE 
 
REF: A. TAIPEI 2626 
     B. TAIPEI 2731 
 
Classified By: Acting Director David Keegan, reason 1.4 b 
 
1.  (SBU) Summary: Medical device manufacturers continue to 
face administrative difficulties in securing registration 
documents from the Department of Health (DOH), but are 
optimistic that registration will be completed for almost all 
products by the December 20 deadline.  DOH has a timeline for 
progress and the new Director General of the Bureau of 
Pharmaceutical Affairs (BOPA) has repeatedly insisted he is 
willing to find creative ways to overcome obstacles. 
However, the BOPA staff is not getting the message.  End 
Summary. 
 
======================== 
The Origins of a Problem 
======================== 
 
2.  (SBU) In 2004, Taiwan DOH announced that all medical 
device manufacturers would be required to register all 
products (including Class 1, 2, and 3 products) beginning in 
2005 before these goods would be allowed to be imported or 
sold.  Previously, only selected devices that raised specific 
safety concerns were required to be registered (Class 3 and 
some Class 2 products).  Due to unclear registration 
procedures, a lack of staff, uneven application of 
requirements and foot-dragging on the part of some medical 
device suppliers, the June 20 deadline for registration was 
unachievable.  Of the several thousand applications submitted 
by medical device manufacturers and importers, only about 200 
licenses were issued before June 15.  After frantic attempts 
to meet the deadline failed and AIT was forced to make strong 
representations to the Taiwan government in support of 
American medical device suppliers, DOH decided to postpone 
the registration deadline to December 20 and allow continued 
use and importation of unregistered medical devices. 
 
========================= 
"Problem?  What Problem?" 
========================= 
 
3.  (C) With less than two months before the new deadline, 
medical device manufacturers express optimism that the 
majority of their products will be able to complete the 
registration process and be issued licenses before December 
20.  Xie Wen-jian, Managing Director for Johnson & Johnson, 
the largest medical device supplier in Taiwan, told AIT that 
80% of J&J's applications had already been approved by DOH 
and licenses had been received.  This was compared to about 
60% at the end of June.  Those that had not yet received 
approval included some in-vitro diagnostic devices (IVDs) and 
others that were facing restrictions because of rules of 
origin concerns.  He noted specifically a diabetes testing 
kit that was facing exclusion because the meter was made in 
China. 
 
4.  (C) Xie praised the new BOPA Director General, Dr. Liao 
Chi-chou but expressed concern that BOPA staff was not fully 
supportive of the DG's willingness to solve problems. 
According to Xie, many of the registration examiners are 
leaving because of long hours and pressure to complete the 
registration process on time.  Examiners are unwilling to 
make judgment calls when protocols do not exactly fit 
circumstances, he complained.  For example, J&J is 
encouraging DOH to accept U.S. and EU approval documents in 
lieu of additional documentation from companies, but have 
been rebuffed by examiners in spite of the BOPA DG's express 
support for J&J's suggestion.  These factors slowed the 
registration process.  J&J's offer of training assistance was 
declined by DOH. 
 
========================================== 
Well...If there is a problem, we'll fix it 
========================================== 
 
5.  (U) In a meeting with members of the American Chamber of 
Commerce Medical Devices Committee October 25, DG Liao 
recognized that many in DOH were not open to change and 
complained that even his own staff did not always follow the 
policies he put in place, but he vowed that DOH would fix any 
problems that prevented suppliers from registering their 
products in a timely fashion.  He noted that by June 20 DOH 
had received 9600 applications for registration, far more 
than they had anticipated.  However, he was also optimistic 
that most, if not all, registrations could be completed by 
the December deadline.  He reiterated DOH's commitment to 
protecting the health of Taiwan citizens and promised that 
DOH would make every effort to assure that applications filed 
on time and in good faith would not be excluded from the 
Taiwan market - even if not approved by the deadline. 
However, he rejected the possibility of again extending the 
registration deadline beyond December 20. 
 
================================= 
Comment: If Wishes were Horses... 
================================= 
 
6. (C) Dr. Liao's positive can-(and will)-do attitude is a 
welcome change from that of his predecessor at BOPA, Dr. Wang 
Hui-bo.  But Dr. Wang's staff remains in place within BOPA 
and several members of the AmCham medical devices committee 
commented to AIT Econoff that the reluctance of these 
staff-members to follow Dr. Liao's orders was leading to 
questions about his ability to survive in DOH's bureaucratic 
and conservative culture.  Despite clear problems with the 
registration process, the medical device community continues 
to tell AIT that they are optimistic that registrations can 
be completed by December.  We are skeptical. 
 
7.  (C) We note J&J's claim that 60% of their products had 
been approved by last June -- given that according to DOH at 
that time only about 200 products total had been certified by 
that date, J&J's statement casts doubt on their current claim 
that 90% of their products already have or will soon complete 
the registration process.  In the months prior to the June 
deadline, we heard similar expressions of misplaced optimism 
until suppliers came face to face with the reality that most 
of their products would not be allowed to enter Taiwan.  The 
resulting near-crisis was averted only after a strong AIT 
intervention on behalf of American medical device suppliers 
when DOH decided to ignore the advice of its own legal staff 
and extend the registration deadline.  While we are hopeful 
that a similar exercise can be avoided in December, we do not 
share the optimism of the medical devices community.  End 
Comment. 
KEEGAN