Taiwan’s Pharmaceutical Affairs Act regulates both pharmaceutical products and medical devices. Under the provisions of the Act, medical device manufacturers seeking access to the Taiwan market must obtain a license for the manufacture or selling of medical devices, and have their devices reviewed and approved by the Taiwan Food and Drug Administration (TFDA) and the Department of Health (DOH). Documentation required in support of a medical device review and approval varies based on the degree of risk the device poses to humans.
At a minimum, most manufacturers are required to submit a detailed company description, a description of their production process and, most important, quality system documentation (QSD) that meets Taiwan’s good manufacturing practice (GMP) requirements. QSD must be audited and certified by an independent third-party. Prior certification to ISO 13485, is accepted in some cases as evidence of compliance with Taiwan’s QSD/GMP requirements, and may streamline the device review and approval process.
Taiwan and the European Union (EU) have entered into a technical cooperation program, which can also facilitate access to the Taiwan market for medical devices that have received prior EU approval.
TÜV SÜD Taiwan has been identified as a TFDA partner under the Taiwan-EU technical cooperation program, and is also accredited by the International Laboratory Accreditation Cooperation (ILAC) for testing to IEC 60601-1. TÜV SÜD can provide complete electrical safety testing for medical devices, as well as testing for medical packaging. TÜV SÜD is also an accredited certification body (CB) for ISO 13485, and can provide comprehensive auditing and certification services in support of Taiwan’s QMD/GMP requirements.
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