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47
Food and Drug Administration
c. Train seeded regulatory personnel
In collaboration with the Center for Drug Evaluation (CDE) and the 37 seeded regulatory
personnel, TFDA began on-site consultation in the Hsinchu Biomedical Science
Park and the Lujhu Kaohsiung Biomedical Park to help industry overcome regulatory
obstacles.
Section 2 Medical Devices Source Control
Status
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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.
Policy and Outcome
1. The Internationalized GMP Regulation for Medical Devices
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was
announced and the
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was amended.
The 2003 version of ISO 13485 was thereby adopted for implementation. It was set forth
that
“
Class 1 medical devices that are non-sterile or without a measuring function
”
and
“
medical devices for use in clinical trials
”
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domestic manufacturing factories to a higher level.
(2) Signing of Technical Cooperation Programme between authorized auditing organizations
of Taiwan and European Union
In 2013, the signing of
“
Technical Cooperation Programme, TCP II
”
was completed
between 4 TFDA authorized auditing organizations and 11 EU notified bodies. Both
sides would recognize the mutual acceptance of audit reports, which effectively reduced
duplicate inspections of the quality system for 18 manufacturers and enhanced the pace
of medical device entrance into the global market.
2. Systemic Oversight of Authorized Auditing Organizations
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Plastics Industry Development Center. In order to facilitate the global alignment of medical
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“
headquarter assessment
”
and
“
witness
assessment
”
on authorized auditing organizations to ensure the quality of audit.