Page 17 - 2021 Taiwan Food and Drug Administration Annual Report
P. 17

Act”   FRQWUROOHG  GUXJV  DUH  FDWHJRUL]HG  LQWR          Section 5

four categories: their potential for habitual             Overview of Medical
XVH   GHSHQGHQFH   DEXVH   DQG  GDQJHU  WR  VR-           Devices and Cosmetics
                                                          Management
ciety. The source management of various
W\SHV  RI  XVHUV   VXFK  DV  LQVWLWXWLRQV   LQGXVWU\      I. Medical devices management
RSHUDWRUV   SK\VLFLDQV   GHQWLVWV   YHWHULQDUL-             framework
DQV  RU SDUDYHWHULQDU\ ZRUNHUV  LV FRQGXFWHG 
WKURXJK FHUWL¿FDWLRQV VXFK DV FRQWUROOHG GUXJ                Following technological advancement
UHJLVWUDWLRQ  FHUWLILFDWH   XVH  OLFHQVH   DQG  H[-       and increasing demand for technological
SRUW   LPSRUW   DQG  PDQXIDFWXULQJ  DJUHHPHQW             PHGLFDO  DQG  KHDOWK  GHYLFHV   WKH  PHGLFDO  GH-
7KH  IORZ  PDQDJHPHQW  LV  DOVR  VWUHQJWKHQHG             vice industry has become one of the most
                                                          promising industries in the biotechnology
requiring users to register and declare the               sector in Taiwan. In response to the booming
LQFRPH   H[SHQVH   DQG  EDODQFH  RI  FRQWUROOHG           development of domestic medical device
GUXJV LQ OHGJHUV  WR SUHYHQW WKH XVH RU DEXVH             LQGXVWU\   7)'$  KDV  HVWDEOLVKHG  D  TXDOLW\ 

of controlled drugs. Its management struc-

ture is shown in Figure 1-6.

Registration                                   Reporting  Inspection          • Registration certificate of
                                                                                controlled drug
                                 Institutions  Health authorities
                                                                                (institutions, business operators)
                                      Diversion                    Licensing
                                    management                       system   • License of controlled drug

                                   Schedule                                     [dentists, physicians, and veterinarian]
                                 management
                                                                              • Permit for exporting, importing
                                                                                and manufacturing

                                                                                (Source management)

                                                                              • Relevant license: transportation
                                                                                permit, letter of approval for
                                                                                medical education, research,
                                                                                and trial

Four schedules of management
according to addictiveness,
dependence, abuse, and social
risks. Schedule 1 is relatively
risky.

              Figure1-6 Management structure of controlled drugs

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