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台湾における医療機器の承認 (英語)

医療機器市場における承認に確信を

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. Overseas manufacturers must engage a local legal representative, which e.g. can be a distributor or importer.

Taiwan’s Pharmaceutical Affairs Act

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 (e.g. for class 1, a statement of conformity is sufficient, for class III Technical Documentation has to follow the STED format).

At a minimum, manufacturers of class II and class III medical devices are required to submit a detailed company description, a description of their production process , technical documentation, a clinical report 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.

R.O.C. TFDA Authorized Medical Device GMP Auditing Organizations and EU AIMD/MDD/IVDD Notified Body Partners have entered into a Technical Cooperation Program which can facilitate access to the Taiwan market for medical devices that have received prior EU approval. In this context, TÜV SÜD played a major role in the negotiations and implementation of this private agreement. An audit report issued by TÜV SÜD for European medical device manufacturers, including the Taiwanese regulations plus certification under ISO 13485 and a Free Sales Certificate, suffice for the GMP compliance letter which is required for the registration of products in Taiwan.

Why choose TÜV SÜD

TÜV SÜD is a TFDA partner under the Taiwan-EU technical cooperation program.

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