Taiwan’s Food and Drug Administration (TFDA) will streamline documentation requirements for medical device applications starting October 1, 2026. Applicants for Class I, II, and III device registrations may submit color-scanned PDFs electronically rather than mailing physical originals. Companies must retain the original documents on hand for inspection. The TFDA will also stop issuing paper copies of approved labels, instructions for use, and packaging materials for Class II and III device registration and variation applications. Approved versions will instead carry an electronic cross-page seal and remain accessible through the agency’s medical device licensing system.
For companies that continue to file on paper, the TFDA has cut the required draft submissions of labels, instructions for use, and packaging from two copies to one. The agency states the changes are intended to raise administrative efficiency and support energy conservation and carbon reduction goals.
One paper-based obligation remains in place. Companies must still mail the TFDA the original medical device license and approval letter within one month of receiving an electronic approval for a license change or renewal. The measures apply across registration, license-change, and renewal filings for Class I, II, and III devices marketed in Taiwan.