MEDICAL DEVICE REGISTRATIONS FACE DECEMBER DEADLINE

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