This case study demonstrates Artixio’s Successful Registration of a Surgical Device in Taiwan with FDA.
Client: A leading global surgical device company
Challenge: The client had a surgical device that they wanted to register in Taiwan. The regulatory body in Taiwan, the Food and Drug Administration (FDA), has stringent requirements for medical device registration.
Solution: Artixio, with its deep understanding of international regulatory standards and quality management systems for medical devices, stepped in to streamline the process. The team at Artixio worked closely with the client to understand the specifics of the surgical device and prepared a comprehensive dossier for the product as per Taiwan FDA guidelines.
The registration process involved several steps:
Determine Classification: The team determined the classification of the surgical device according to the risk-based classification system established by the Taiwan FDA.
Prepare Documentation: The team prepared the required documentation, which included manufacturer information, device description, technical documentation, clinical data, labeling and Instructions for Use (IFU) in Chinese, quality management system documentation, and regulatory documents.
Appoint an Authorized Representative: As the client was a foreign manufacturer, Artixio acted as the authorized representative in Taiwan.
Submit Application: The team prepared and submitted the application for registration to the Taiwan FDA.
Review and Evaluation: The Taiwan FDA reviewed the submitted documentation and evaluated the compliance of the device with regulatory requirements.
Inspections and Audits: The Taiwan FDA conducted inspections or audits of the manufacturing facilities to verify compliance with quality and safety standards.
Outcome: With Artixio’s expert guidance, the client successfully registered their surgical device with the Taiwan FDA, enabling them to expand their market reach in Taiwan. This case underscores Artixio’s commitment to helping medical device companies navigate complex regulatory landscapes and achieve their business objectives.
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