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Food and Drug Administration


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


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