On 19 May 2026, the Taiwan Food and Drug Administration (TFDA) issued a draft amendment to Attachment 2 of Article 6 of the Regulations Governing Border Inspection and Examination of Imported Medical Devices.
The draft is currently open for a 60-day public consultation period following publication in the official gazette.
Read the full announcement here: https://www.fda.gov.tw/TC/newsContent.aspx?cid=5072&id=31549
Purpose of the Draft Amendment
To update inspection requirements under Attachment 2 of Article 6 of the Regulations Governing Border Inspection and Examination of Imported Medical Devices.
To revise border inspection requirements for selected condom products imported into Taiwan.
Scope of Application
The proposed amendment applies to the following imported medical devices:
- L.5300 Condom (4014.10.00.10)
- L.5310 Condom with spermicidal lubricant (4014.10.00.90)
Key Updates
The proposed amendment focuses on inspection requirements for condoms and condoms with spermicidal lubricant.
Key revisions include:
- Update to pin-hole test designation under CNS 6629 T2008
- Increase in batch sampling size for border inspection
- From 315 → 328 units (≤500,000 units per batch)
- From 500 → 513 units (>500,000 units per batch)
References
Read to learn more:
- TFDA Announcement No. 1151603290 (Traditional Chinese only)
- Explanation of the Draft Amendment to Attachment 2 of Article 6 of the Regulations Governing Border Inspection and Examination of Imported Medical Devices (Traditional Chinese only)
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Taiwan, please contact info@nordpacificmed.com.