Ensuring Compliance with Taiwan's Medical Devices Regulations

Taiwan, with its nearly 24 million population and a focus on biotechnology, pharmaceuticals, and medical devices sectors, presents a significant opportunity for the medical device industry. Driven by an aging population, the demand for high-end medical devices, of which approximately 60% are imported, is on the rise. The Medical Devices Act (2021) governs the regulatory landscape, emphasizing the importance of adherence to quality and safety standards.

Device Classification and Regulatory Pathways

Navigating the TFDA's Requirements

Regulatory Authority

The Taiwan Food and Drug Administration (TFDA) administers the Medical Devices Act, classifying medical devices into three risk categories: Class I, II, and III. The Act mandates pre-market approval for all devices, with Class I non-sterile devices being the exception. Manufacturers are required to obtain ISO 13485 certification and undergo a quality system review, leading to the issuance of a Certificate of Quality System Registration (QSD) valid for three years.

Classification

Devices are categorized based on risk, with Class I being the lowest and Class III the highest. This classification dictates the regulatory requirements, including the necessity for a technical dossier for Class II and III devices, encompassing test reports and clinical data.

Key Requirements

To enter the Taiwanese market, foreign manufacturers must:

  • Appoint a Taiwan Agent to facilitate interactions with the TFDA.
  • Obtain ISO 13485 certification for all devices, excluding Class I non-sterile devices.
  • Submit a quality system review application to obtain a QSD, followed by the device registration application.
How We Can Help

Tailored Support for Market Entry

Our services are designed to simplify your regulatory process in Taiwan:

  • Assistance with product classification and identification of the regulatory pathway.

  • Compilation of the technical dossier required for TFDA registration.

  • Acting as your Taiwan Agent, managing the registration with TFDA and ensuring compliance with post-market regulations.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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