Medical device manufacturers must appoint, and grant Power-of-Attorney to a local, registered company in Taiwan to submit registration applications and act as Taiwan Agent. The Taiwan Agent will be listed on the local labeling and be responsible for post market vigilance reporting, the proactive traceability of devices on the market and retention of device history documents.
Licenses in Taiwan are transferrable and will need to be completed by both the transferor and the transferee jointly. To learn more about license transfers, please visit our Taiwan Medical Device Registration page.
Asia Actual is a full-service provider of medical device license-holder services in Taiwan. Contracting with us as your Taiwan Agent allows you to:
sell directly to multiple regional distributors (avoiding mark-up by a national importer)
increase transfer pricing (as distributors are not investing in registration costs)
improve leverage in distributor negotiations/responses
keep intellectual property away from local commercial agents
expert handling of license maintenance and post market vigilance
License Holders do not need to be involved in the importation of products but will need to authorize qualified Distributors that comply with the new Good Distribution Practices (GDP) requirements when implemented in 2021/2022.
GROW WITH US
Asia Actual is available to help navigate the medical device registration requirements and regulatory pathway for medical device and IVDs in Taiwan.
Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the Taiwanese market.