Quality assurance: Dahua is designated by the National Health and Family Planning
Commission of the People’s Republic of China (NHFPC) and the China Food and
Drug Administration (CFDA) as an approved manufacturer of contraceptive prod-
ucts. Dahua continually evaluates the quality of the final product by testing each lot
prior to distribution. Since 2008, an independent quality evaluation has been
conducted annually by FHI 360. The findings show Dahua demonstrates the ability to
produce a contraceptive implant that meets international quality standards
Earlier clinical trials: Chinese clinical data from the early 1990s from 4 randomized
trials among over 15,000 women support 4-year duration of use of Sino-implant (II),
with annual pregnancy rates below 1 percent.2 With funding from the Bill & Melinda
Gates Foundation and the U.S. Agency for International Development, FHI 360 and
partners have since completed prospective cohort studies in Bangladesh, Kenya,
Madagascar and Pakistan, following over 2,000 Sino-implant (II) users for 12 months.
The results show Sino-implant (II) is a safe, highly effective method. In Bangladesh
and Madagascar, no post-insertion pregnancies were reported; in Kenya and
Pakistan, the combined annual pregnancy rate was below 1 percent.