Taiwan's device licence moves with the agent, not the maker

Three classes, and a licence that doesn't sit with the manufacturer

Taiwan's Medical Device Act — passed by the Legislative Yuan in December 2019 and in force since 1 May 2021, replacing the device-specific provisions that had previously sat inside the older Pharmaceutical Affairs Act — sorts devices into three risk classes, I through III, low to high. What the Act doesn't do, for a foreign manufacturer, is let that manufacturer hold the resulting device licence directly. A manufacturer with no Taiwan establishment has to appoint a Taiwan-licensed domestic agent, and it's the agent, not the manufacturer, whose name the licence is actually issued to.

The agent applies, reports, and answers to the regulator

That assignment isn't a formality that ends at filing. The domestic agent is the party of record who submits the registration application, and who carries the Act's own reporting duties once the device is on the market — serious adverse event reports, corrective and preventive actions, and recalls all run through the agent, because the agent is who Taiwan's Food and Drug Administration has on file as accountable for the device, not the overseas company that designed and built it. A distribution agreement that treats a Taiwan agent as a sales channel, without naming it as the party legally holding and answering for the device licence, has left the actual regulatory relationship undocumented.

Two clocks, one of them waivable

Once issued, a device licence is valid for five years. Most Class II and III devices — and sterile or measuring Class I devices — also depend on a second, separate credential: Quality System Documentation, TFDA's own site-level certification of the manufacturer's quality management system, built around ISO 13485 and reviewed on a document basis for a foreign manufacturing site rather than through an on-site inspection. That certification runs on a three-year cycle, shorter than the five-year licence it supports, and only a non-sterile Class I device is exempt from needing one at all. For a foreign manufacturing site, TFDA reviews the QSD application on the documents alone, without an on-site inspection; a local Taiwan manufacturer goes through an on-site audit run by a TFDA-authorized auditing organization instead. Either way, the certificate that comes out expires on its own three-year schedule, and a renewal calendar keyed to the licence's own five-year date alone is missing the shorter clock the licence depends on to stay valid in between.

Moving the licence takes the old agent's cooperation, not a fresh filing

Because the domestic agent holds the licence rather than merely representing the device, changing agents isn't a new application — it's a transfer, and Taiwan's own registration regulations require the outgoing and incoming agents to file that transfer jointly, with the Quality System Documentation certificate able to move alongside it in the same transaction. That structure works cleanly when both agents are willing to sign. It becomes a real constraint when they aren't: a manufacturer that wants to leave an underperforming agent, and finds that agent unwilling to co-execute the transfer, doesn't have a unilateral path to reclaim the licence and hand it to someone else. The relationship a manufacturer signs with its first Taiwan agent is, in that sense, harder to exit than the licence application that follows it.

Where this meets the file

A Taiwan market-access record needs the domestic agent named as the licence holder of record, not as a distributor line item, with its own renewal date tracked separately from the shorter Quality System Documentation cycle underneath it — and a standing note of what a change of agent actually requires before one becomes necessary. A cross-border registration tracker built to carry that structure, alongside the launch catalog's other device-registration templates, is previewed there now. If your program has run a Taiwan agent transfer and found a gap this one misses, the shelf takes that correction directly.