Thai FDA Class 2–4 Device Change Timelines and Fees

Thailand's Medical Device Control Division (MDCD) published an announcement on Class 2–4 device changes on 2 November 2026, publicizing review timelines and conditions applicable from 21 October 2026. Its detailed procedure chart distinguishes applications supported by an approved change from a reference country from applications without that support. IVDs are in vitro diagnostic medical devices; fees below are stated in Thai baht (THB).

The update concerns changes to notified and licensed medical devices, including IVDs, in Thailand. It supplements the electronic change-notification system; it is not a new initial-registration pathway. The practical decisions are how a change package is grouped, whether external expert review is needed, which published review period applies, and which fees must be budgeted.

Approved changes from a reference country

For an application supported by an approved change from a reference country, the chart lists internal review without external expert referral. It allows one correction round and five working days for the applicant's response.

Boundary requiring confirmation: The official chart overlaps at exactly 10 added items: one row says up to 10, while the next says 10 or more. The source does not resolve that case. Applicants with exactly 10 additions should obtain MDCD confirmation before selecting a timeline for planning or making a filing decision.

The chart's footnote identifies four item-addition topics: adding device items (Major), adding items of the same design (Major), adding device items or software without an effect on performance characteristics and product specifications (Minor), and adding accessories for the main device (Minor).

Reference-country support must relate to the change, rather than merely the device's original authorization. The cited chart does not list eligible reference countries or fully define acceptable supporting evidence. Applicants should confirm those eligibility and documentation points with MDCD; this article does not infer them from foreign market authorization alone.

Applications without reference-country change approval

The second matrix uses the number and severity of change topics. For Conditions 2–5, it states the equivalence three Minor topics = one Major topic.

A second unresolved boundary: Conditions 4 and 5 overlap at exactly five Major topics. MDCD should confirm the applicable condition for that case. The table above preserves the official wording; it does not resolve the overlap by assigning an application to either tier.

The chart gives mixed-package examples. Three Minor topics plus one Major topic appear under Condition 3; three Minor topics plus three Major topics appear under Condition 4; and three Minor topics plus four Major topics appear under Condition 5.

Without expert referral, Conditions 2–5 permit one officer correction round. Condition 2 gives the applicant five working days to respond; Conditions 3–5 give ten working days. With expert referral, the chart provides one officer round and one expert round, with five working days per response in Condition 2 and ten working days per response in Conditions 3–5.

The published periods are working days, rather than calendar days. The chart separately lists review periods and applicant correction windows. It does not establish a guaranteed end-to-end approval date, and this article does not assume how every correction or completeness issue affects elapsed time.

Official fees and when expert costs apply

The chart lists a THB 500 application fee. When external expert assessment is required, the following technical-evaluation fees are added:

Without expert referral, the chart specifies only the THB 500 application fee. These are official filing and assessment charges; they do not represent a manufacturer's complete change-management budget.

Pure Global calculation: For an import notification that would otherwise require expert review, a qualifying non-expert submission changes the listed official total from THB 24,500 to THB 500, a THB 24,000 difference. For an import licence, the corresponding difference is THB 30,000. The comparison depends on expert referral being required in the alternative case; it is not a saving available on every submission.

Pending applications submitted before 21 October

The announcement allows applicants with a reference-country-approved change and a pending application submitted before 21 October 2026 to provide additional information through the relevant MDCD email channel:

• General medical devices: changegeneralmdcd@gmail.com, telephone 0 2590 7243.
• Active medical devices: activemdcd@gmail.com, telephone 0 2590 7244.
• IVD medical devices: IVD_THFDA@fda.moph.go.th, telephone 0 2591 8479.

These contacts are reproduced from the official announcement poster. The notice does not state a separate closing date for providing the additional information. Applicants should confirm their pending file's treatment with the responsible unit rather than assume an automatic transfer or restart.

What the matrix changes for filing decisions

Pure Global analysis: Map the actual change topics and reference-country evidence before estimating the timetable. A package of four Minor topics falls into a different printed band from a package of three Minor topics, so the scope of a submission can materially affect planning. That comparison does not establish that interconnected changes may be split or that a required notification can be delayed.

For an existing pending file, check the original submission date and whether the change has reference-country approval before using the supplemental-information channel. For a new file, confirm eligibility, expert referral, and any overlapping boundary with MDCD, then budget the applicable official charges and response resources. The reliable planning benefit is a source-backed decision matrix, rather than a promised approval date.