Based on official regulations and the latest implementation rules released by Thailand TFDA, we fully sort out the timeline, document requirements and overdue risks for medical device license renewal in Thailand. Notably, renewal requirements have undergone major changes for products previously approved via simplified pathways.
The official renewal fees set by Thailand TFDA align with the initial registration fees, varying by product risk class (Class 2 / 3 / 4).
Renewal applications can be prepared as early as 364 days before the certificate expiry date. Manufacturers are advised to start document preparation at least one year in advance to reserve sufficient time for review and supplementary materials. All renewal applications must be submitted and paid online via the official SKYNET system.
If renewal approval is not completed before the expiry date, the certificate loses legal effect starting January 1 of the following year, and the relevant devices cannot be imported or sold in Thailand. Expired certificates cannot be renewed retroactively; companies must restart the full registration process from scratch, resulting in drastically higher time and financial compliance costs.
Only under exceptional circumstances, applications submitted within 1 month after expiry with a reasonable delay statement may be accepted subject to daily fines. This is not a formal grace policy and companies should not rely on this exception.
Screen batches due for renewal immediately: Sort out your inventory of Thailand registered products, prioritize preparation for items expiring between 2027 and 2028 that were originally approved via Partial pathways.
Upgrade technical documents in advance: For Partial pathway products, complete full CSDT technical files, updated clinical data and quality system certifications ahead of schedule to avoid last-minute document shortages.
Submit applications early during the annual window: File applications promptly once the submission portal opens every October to avoid backlogs and delays from year-end concentrated submissions.
Complete variation filings prior to renewal where applicable: If changes occurred during the certificate term (e.g., manufacturing site, product design, labelling), complete variation filings first before submitting renewal applications, or follow TFDA’s official sequential processing guidance.
Brazil boasts the largest and most mature medical device regulatory market across Latin America, making it a core target for Chinese medical device manufacturers expanding into South America. To celebrate Wiselink’s 6th anniversary, we are launching a limited-time offer: 20% off consultation fees for all risk classes of medical devices for the Brazilian market, valid June 18 – July 18. New and existing clients are welcome to reach out.
