Page 81 - 2018食藥署年報(英文版)

TFDA ‧Policy planning
‧Initiate consultation meetings
Core team
CDE ‧Assist in exploring more cases
‧Assist in clinical trial assessments

Medical Device Advisory Board members

External
sources
Experts and scholars in respective fields

Figure 5-3. Operational framework of the medical device project counseling and
assistance team

Implementation Measures

1. In May 2011, the Administration started a program based on the document “Principles for
Medical Device Consultation.” The program aims to support R&D teams through one-on-one
consultation and provide the R&D teams with advice on pre-clinical and clinical validations
during their product development. The targeted medical devices of this program are Class II or
III medical devices still under development and not available in the domestic market or medical
devices seeking for multicenter international clinical trials, in which the medical devices
must meet any of the following criteria: first domestic case (FDC), best in class (BIC), new
indication in health (NIH), milestone for TFDA (MFT), and multicenter clinical trial (MCT).

2. Through the above program, an R&D team can establish a close correspondence with the
regulatory and technical teams within and outside of the Administration since the early R&D
phase. The Administration will hold consultation meetings depending on the circumstances,
where members of the Medical Device Advisory Board, experts, and scholars will also be
invited to help the R&D team to address issues in the consultation meetings.
3. In order to provide manufacturers and the public with quick assistance on medical devices,
the Administration has authorized the Center for Drug Evaluation (CDE) to set up a hotline

at (02)8170-6008 for basic consultation regarding the regulations of medical devices. The
manufacturers and the public can ask questions about laws and regulations on the registration
and clinical trials of medical devices on this hotline. In addition, the CDE also trained seeds
from local communities to address basic regulatory inquiries, and allows manufacturers from
biomedical science parks to reserve in-park regulatory consultation services.

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