Taiwan FDA Announces 2026 Recognized Medical Device Standards and Abolished Standards List

On August 3, 2026, the Taiwan Food and Drug Administration (TFDA) released its 2026 Medical Device Standard Recognition List, alongside an updated list of standards repealed over the years.

This update significantly overhauls the compliance landscape for medical devices in Taiwan, requiring foreign and domestic manufacturers to audit their technical dossiers immediately to avoid unexpected regulatory delays.

What Changed in the 2026 Medical Standards List?

The 2026 recognition list includes 1,393 recognized medical device standards covering a range of therapeutic and technical areas.

Key changes include:

• 87 new standards added to address emerging technologies, updated testing methods, and evolving international standards
• 8 standards abolished and removed from the recognized list
• 1,306 standards carried over from the previous list of 1,314 recognized standards, including 175 standards with revised or updated versions

Note: The TFDA also published a separate list covering 272 previously recognized standards that have been repealed or superseded.

What Manufacturers Should Do Next

Because relying on outdated or repealed standards is one of the quickest ways to stall market access, manufacturers should proactively adjust their technical documentation:

• Audit Technical Files: Scan your technical documentation for references to ISO, IEC, ASTM, or CNS standards. Replace any obsolete or repealed versions with current references.
• Review Ongoing Submissions: Check pending market applications, renewals, and registrations to verify whether test data or declarations of conformity require a refresh.
• Conduct Gap Analyses: Where standards have been revised, evaluate whether the changes impact your current testing, clinical evidence, or risk management files.
• Align Manufacturing Practices: Ensure pre-market testing and quality processes stay tightly mapped to active TFDA standards.

Final Thoughts

With Taiwan’s 2026 standards now in effect, reviewing your technical documentation is an essential step to safeguarding your market access and avoiding unnecessary registration delays. Whether you are preparing a new submission or renewing an existing product license, auditing your files against these newly revised, replaced, or abolished standards ensures your compliance strategy remains seamless.

Partnering with local regulatory experts can streamline this transition. Cisema helps life-sciences companies navigate shifting requirements across Taiwan and the broader APAC region through tailored regulatory strategies, comprehensive gap analyses, and end-to-end registration support.

To ensure your portfolio stays compliant, contact Cisema today to discuss how our team can guide your medical device strategy in Taiwan.

Further Information

Explore Cisema’s services for medical device registration in Taiwan.

References

Announcement of the "2026 Medical Device Standard Acceptance List" and the "List of Previously Abolished Medical Device Standards"