On 3 August 2026, the Taiwan Food and Drug Administration (TFDA) announced the 2026 Annual Recognized Medical Device Standards List, together with a separate list of previously recognized standards that have been withdrawn or superseded.
The 2026 update covers 1,393 recognized medical device standards, including 87 newly added standards and 175 updated or revised standards. TFDA also published a separate list of 272 previously recognized standards whose original versions have been withdrawn or superseded.
While this may appear to be a routine regulatory update, it reflects Taiwan’s continued commitment to international regulatory harmonization and alignment with global standards.
Read the full announcement here:
https://www.fda.gov.tw/TC/siteListContent.aspx?sid=11652&id=51410
Key Updates
Updated Recognized Standards List
According to the statistics provided by TFDA, the newly published recognized standards list includes a total of 1,393 medical device standards, consisting of:
| Items | Numbers |
| Newly Added Standards | 87 |
| Updated/Revised Standards | 175 |
| Withdrawn Standards | 8 |
| Total Recognized Standards | 1,393 |
The recognized standards cover a broad range of international and domestic standards applicable to medical device safety, performance, quality, biocompatibility, electrical safety, software, sterilization, and other technical requirements, including ISO 15223-1, ISO 7010, ISO 10993 series, IEC 80601-2-77, and IEC 60417.
1,393 recognized medical device standards
TFDA’s 2026 list contains a total of 1,393 recognized standards.
87 newly added standards
87 newly added standards
The update introduces 87 newly recognized standards, which manufacturers should review to determine whether they apply to current or planned products.
175 updated or revised standards
A further 175 standards have been updated or revised, making it important for manufacturers to check whether existing testing, technical documentation, or regulatory submissions reference older editions.
272 previously recognized standards withdrawn or superseded
TFDA has published a separate list covering 272 previously recognized standards whose original versions have been withdrawn or superseded.
TFDA encourages manufacturers to transition to the latest editions or appropriate replacement standards as early as possible.
Continued regulatory harmonization
TFDA stated that the update is intended to facilitate international regulatory harmonization and provide the medical device industry with up-to-date technical references for research, development, and manufacturing activities.
This makes the update more than a routine revision of standards. It is also a strategic signal of Taiwan’s continued movement toward internationally aligned medical device requirements.
References
- TFDA Announcement No. FDA-MD-1151607273 (Traditional Chinese only)
- Attachment 1: 2026 Recognized Medical Device Standards List (1,393 standards) (Traditional Chinese only)
- Attachment 2: List of Withdrawn Previously Recognized Medical Device Standards (272 standards) (Traditional Chinese only)
Implications to Client
Manufacturers planning new registrations or maintaining existing approvals in Taiwan should use this update as an opportunity to review their regulatory documentation and standards strategy.
Clients should:
- Review the 2026 recognized standards list and identify newly added or revised standards applicable to their devices.
- Check whether technical documentation, testing reports, and existing submissions reference withdrawn or superseded standards.
- Assess whether changes to applicable standards could affect testing, technical documentation, or future regulatory submissions.
- Consider gap assessments, risk assessments, change control activities, re-testing, and/or documented justifications where appropriate.
- Pay particular attention to standards relating to electrical safety, EMC, software, cybersecurity, sterilization, biocompatibility, symbols, and other technical requirements.
- Review applicable standards not only when preparing a new submission, but also during product development, registration review, and post-market maintenance.
For companies operating across Asia-Pacific, this means regulatory success increasingly depends not only on meeting current requirements, but also on actively monitoring how recognized standards evolve across key markets.
Are you actively monitoring standards updates across your key Asia-Pacific markets, or only when a submission is due?
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Taiwan, please contact info@nordpacificmed.com.