The TFDA Positive List is the mechanism that enables auto-approval for Class 1 medical devices and is one of the most practically useful regulatory tools available to foreign manufacturers entering the Thai market. Despite its significance, it is poorly understood by many manufacturers and their regulatory teams, leading to missed opportunities for dramatically faster market entry and, in some cases, wasted preparation costs when devices that do not qualify are submitted through the auto-approval pathway.
What the Positive List Actually Is
The Positive List is a TFDA-maintained catalogue of medical device categories, identified by GMDN (Global Medical Device Nomenclature) codes, that qualify for the auto-approval pathway introduced in January 2025. It is a list of device categories, not individual products. A manufacturer cannot add their specific product to the Positive List — qualification is determined by whether the device category (defined by its GMDN code and associated criteria) already appears on the list. The TFDA updates the list periodically as new device categories are assessed for inclusion. This means that an eligibility check performed 12 or more months ago may no longer be current, and devices not previously on the list may now qualify.
Qualification Criteria
A device category appears on the Positive List if it meets all of the following: Class 1 risk classification under AMDD rules; absence of novel technology or novel intended use; and valid marketing approval in at least one recognized reference jurisdiction — US FDA clearance or approval, CE Mark under EU MDR or MDD, PMDA approval (Japan), or TGA registration (Australia). The international reference approval requirement effectively means that the Positive List auto-approval pathway is designed for established, widely accepted low-risk devices with a known international regulatory track record, not for novel or first-in-class products even when they carry a Class 1 risk classification.
What Auto-Approval Looks Like in Practice
An auto-approval application is submitted through the TFDA's e-submission platform with the full required documentation package. The automated system validates application completeness and checks the device against Positive List criteria using the GMDN code. If the application passes both checks, registration is issued within three to five business days. If the application fails — due to missing documentation, incorrect classification, or a device that does not match Positive List criteria — it is returned for correction and resubmission, resetting the clock entirely. The value is entirely in the timeline. Documentation requirements are identical to a standard Class 1 submission and there is no reduction in technical file requirements.
Devices That Do Not Qualify Despite Being Class 1
Several categories of devices that are classified as Class 1 under AMDD rules fall outside Positive List eligibility. Devices with measurement functions (such as thermometers and blood pressure monitors) may carry additional review requirements under Thai rules. Devices with novel intended uses that have not yet established a broad international regulatory track record will not qualify. Devices that are Class 1 in Thailand but classified differently in the reference jurisdiction create a classification mismatch that prevents auto-approval. SaMD classified as Class 1 may have separate registration pathway requirements under the 2025 TFDA SaMD guidelines. Each of these situations requires the standard manual review pathway rather than auto-approval.
Why Current Eligibility Verification Matters
The single most common and costly Positive List error is submitting an auto-approval application based on an eligibility assessment done against an outdated version of the list. The TFDA updates the Positive List, and a device category may be added, modified, or in some cases removed. Before investing in application preparation, a current eligibility check against the live Positive List should be the first step. DeeMED Consulting conducts current Positive List eligibility assessments and prepares auto-approval applications for foreign manufacturers, confirming live eligibility before submission preparation begins to avoid timeline surprises.