Taiwan Market Access
Understanding Taiwan’s Pharmaceutical Affairs Act for medical devices
The medical device market in Taiwan has been enjoying steady growth. With the majority of all medical devices sold or marketed in Taiwan imported, there are significant opportunities for medical device manufacturers.
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.
- Product safety testing and certification - TÜV SÜD Taiwan has been accredited by the ILAC for testing to IEC 60601-1, and can provide complete electrical safety testing for medical devices. TÜV SÜD Product Service is also the largest, most experienced EU Notified Body for all types of medical devices.
- Quality management system certification - TÜV SÜD is an accredited CB for ISO 13485, and can review, certify and audit quality management systems as required by the TFDA.
- Technical and design review - Medical device experts at TÜV SÜD can review technical issues specific to medical device regulations and standards, including requirements related to essential performance, functional safety and risk management.
- Other testing and certification services - TÜV SÜD can provide compliance testing for medical devices for other relevant regulations and standards, including electromagnetic compatibility (EMC).
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.
- Product safety testing and certification - TÜV SÜD Taiwan has been accredited by the ILAC for testing to IEC 60601-1, and can provide complete electrical safety testing for medical devices. TÜV SÜD Product Service is also the largest, most experienced EU Notified Body for all types of medical devices.
- Quality management system certification - TÜV SÜD is an accredited CB for ISO 13485, and can review, certify and audit quality management systems as required by the TFDA.
- Technical and design review - Medical device experts at TÜV SÜD can review technical issues specific to medical device regulations and standards, including requirements related to essential performance, functional safety and risk management.
- Other testing and certification services - TÜV SÜD can provide compliance testing for medical devices for other relevant regulations and standards, including electromagnetic compatibility (EMC).
Your benefits at a glance
- Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Affairs Department, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards. TÜV SÜD clients can enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
- Regional and local proficiency - Our regional medical health experts speak your local language and understand regional and local regulations and knowledge needs.
- Single source solution - TÜV SÜD offers testing services for major medical device markets according to international standards and regulations.