Thai FDA medical device evaluator list No. 23 — electrical and electronic test centre PTEC added

Who has been added

Thai FDA has issued the 23rd addition to its list of experts and organisations qualified to evaluate technical documentation for medical devices. The notification states that it adds to (เพิ่มเติม) the existing list; it does not replace earlier entries.

The annex names the following.

Three individual technical document evaluators

• Asst. Prof. Thammathat Owsirikul (ผู้ช่วยศาสตราจารย์ธรรมธัช โอวศิริกุล)
• Mr. Kraisorn Anchaleewaraphan (นายไกรสร อัญชลีวรพันธุ์)
• Mr. Ruengrit Ninae (นายเรืองฤทธิ์ หนิแหนะ)

One expert organisation or evaluating body

• Electrical and Electronic Products Testing Center (PTEC), under the National Science and Technology Development Agency (สวทช., NSTDA)

PTEC is the substance of this notification

List additions rarely change day-to-day practice, but the character of this one organisation is worth noting. PTEC is a state-agency centre specialising in electrical and electronic product testing. Among medical devices, it sits closest to the competence needed for active devices whose dossiers turn on electrical safety (the IEC 60601 family) and electromagnetic compatibility.

For product families where review has stalled over electrical and EMC test evidence, this reads as one more available route for evaluation. That said, which product families and which document types each evaluator and body actually handles is not stated in this notification. Availability and working scope have to be confirmed case by case.

Legal basis and effect

The notification is made under section 35/2, first paragraph of the Medical Device Act B.E. 2551, as amended by the second amendment of B.E. 2562, together with clause 8 of the FDA notification of B.E. 2567 (dated 2 February 2567) setting the criteria, methods and conditions for obtaining experts and evaluating bodies. It is signed by the Secretary-General of the FDA.

It takes effect "from now on" (ทั้งนี้ ตั้งแต่บัดนี้เป็นต้นไป); no separate commencement date is specified.

A caution on the date

The date on the notification is handwritten. In the scanned copy it reads as 7 September B.E. 2569 (7 September 2026), but a handwritten figure is not something to treat as settled. The FDA website posted the document on 17 September, and the two dates are distinct. If anything turns on when the document took effect, confirm against the original.

What else to check

The specialisation of each evaluator, how the new entries sit alongside the existing list, and the practical conditions for engaging them are not determinable from this single notification. If technical document evaluation is ahead of you, compare the current consolidated list against the evaluation scope each body can take on.