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b. Outcomes of the Consulting Program
As of the end of 2014, TFDA has successfully assisted 13 domestically manufactured medical
devices through to approval, 9 cases entering the clinical trial, and transferred 3 academic research
and development outcomes to the industry, which included clinical trials for the world's first high-
end treatment of cartilage defects, clinical trials for the first innovative negative pressure sleep
apnea treatment device, and approval for the first domestically made one-step artificial dental
implant.
c. Establishing a Regulatory Counseling Center
In collaboration with Center for Drug Evaluation (CDE), TFDA established the medical device
regulations counseling center, which offered up to four dedicated inquiry service helplines starting in
2013 and an additional two voice mailboxes in 2014. A total of 16,276 inquiry calls were received.
d. Training Seed Regulatory Personnel
Personnel for providing consultation are from TFDA, the Center for Drug Evaluation, and 48
well-trained seed regulatory personnel. The namelist of the 48 trained personnel has also been
published online for public access in order to expand the scope of services provided. It is hoped
that the provision of comprehensive and local consultation will help local businesses overcome the
legal barriers as early as possible.
Section 2 Medical Devices Source Management
Current Status
As of the end of 2014, Taiwan had a total of 1,290 registered medical device manufacturers. Ensuring
sustained stable production and management to meet the needs or specifications of the original design is
an important quality assurance for medical devices. The implementation of quality management for medical
device manufacturing is an effective measure for source control. Consistent systematization of management
and alignment with international GMP for medical devices are carried out in order to support the international
marketing of medical device industries. Also, in order to achieve the objectives of source management,
existing quality systems of medical device manufacturers are reviewed using manufacturer site audits or
quality system document checks (for importers). Manufacturers that satisfy Taiwan's GMP will be issued an
approval letter of registration with a valid period of three years.
Policies and Outcomes
1. Systemic Oversight of Authorized Auditing Organizations
There are currently four authorized medical device GMP auditing organizations in Taiwan, including the
Center for Measurement Standards of the Industrial Technology Research Institute (ITRI), Electronics
Testing Center (ETC), Metal Industries Research & Development Centre (MIRDC), and Plastics Industry
Development Center (PIDC). To improve TFDA's capabilities in assessing the certification agencies and
to enhance global alignment of relevant systems, TFDA has commissioned a special program entitled
Enhancement of Assessment Capabilities of Authorized Auditing Organizations, Audit Standards, and
Relevant Regulations for Auditing
to carry out
Headquarter Assessment and Witness Assessment
of the
authorized auditing organizations to ensure audit quality. Training was also provided to the personnel of
these four auditing organizations so that manufacturer auditing results would be based on identical and
consistent standards.
2. Registration Management of Medical Device Manufacturing Factories
Medical device importers should apply for registration letters to demonstrate the compliance of
overseas manufacturing factories with the regulation of R.O.C. Quality System Documentation (QSD).
The audit inspections for domestic manufacturers are primarily conducted on-site. Importers may