Page 54 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

b. Outcomes of the Regulatory Inquiry and Consultation for the Industry
As of December 2015, a total of 16 domestically manufactured medical devices were approved
for marketing, 10 were approved for clinical trials, and five outcomes of R&D efforts were
successfully transferred to the industry. This included the world' s first clinical trial for high level
treatment of cartilage defect, the world's first portable negative pressure wound therapy (NPWT)
system, computer-aided ultrasound diagnostic system for thyroid glands, and the approval for
marketing of Taiwan's first domestically manufactured bio-tissue adhesive.

c. Expanding the Medical Device Inquiry and Consultation Center
A total of six helplines for medical device inquiry (with four dedicated personnel and two voice
message lines) were established. The helplines received a total of 19,926 incoming calls in
2015, which were 3,650 more calls compared to 2014. TFDA also worked with the Biomedical
Science Park and provided four inquiry and consultation sessions to companies within the
park.

d. Training Seed Regulatory Personnel
In 2015, seed personnel were newly recruited from units in the centers of industry-academia
partnerships, innovation & incubation, and medical device research & development. After the
annual training and assessment, there were 45 qualified seed personnel and 11 reserved seed
personnel who were announced publicly on the TFDA website, allowing external parties to
contact them for inquiry services.

Section 2. Medical Devices Source Management

Current Status
To ensure the stable production and management of medical devices are maintained,
a source management system for medical devices has been enforced in Taiwan in order
to supervise the quality management system and support product quality improvements of
medical device manufacturers. A systematic management to align with international GMP
regulatory mechanisms for medical devices were also employed to improve the competitiveness
of the medical device industry in Taiwan and allow the industry to export their products to
the international market. Through a two-track system of on-site audit and quality system
documentation review for medical device manufacturers, objectives of source management would
thereby be achieved.
Policies and Outcomes

1. Enhancing the Consistency of Inspections Carried out by Auditing Organizations
There are four GMP auditing organizations for medical devices in Taiwan, including the Center
for Measurement Standards of the Industrial Technology Research Institute (ITRI), Taiwan
Electronics Testing Center (ETC), Metal Industries Research Development Centre (MIRDC), and
Plastics Industry Development Center (PIDC). In 2015, a Quality and Competence Improvement
Program for Medical Device Inspection was carried out to review case studies of inspection
processes and suspect issues in order to ensure that the inspection results are traceable to
a consistent standard and ensure that relevant systems, regulations, and criteria employed in
factory audits are harmonized with international standards. Guidelines for Commissioning GMP
Certification of Medical Devices (Draft) were also developed which stipulated responsibilities,
competences, experiences, and training required for auditing organizations and personnel
52 commissioned to conduct GMP certification processes.