Cleanroom contractor in Thailand: rules for buyers

By ZY Cleanroom · Updated 2026-11-01 · Sources at the end of the page

Which rules apply to your plant

PIC/S says Thai FDA became its 49th participating authority on 1 August 2016 (PIC/S, August 2016). A Thai FDA study published on 14 August 2026 says the authority faces PIC/S re-assessment and lists, among its gaps, the need to bring the GMP standard up to the current version, PE 009-17 (Thai Food and Drug Journal, volume 33, issue 2, 2026). Ask the owner's quality head which edition governs the project.

For medical devices, two Ministry of Public Health notifications of B.E. 2566 (2023) set quality-system rules: Good Manufacturing Practice for manufacturers, and Good Importing and Sales Practice. From July 2024, new manufacturers of moderate- to high-risk devices must comply and hold a GMP Certificate, a TCAS 13485 Certificate or an ISO 13485 Certificate. Low-risk device makers must upgrade their facilities but need no certificate (Baker McKenzie, via Global Compliance News, 20 April 2024).

Who builds cleanrooms here

Drug plant owners and medical device makers are the regulated buyers. The device rules split by risk class, so the class of each product line decides what the owner must certify. Importers and sellers of devices must fully comply with the separate import-and-sales notification by January 2029 (Baker McKenzie, via Global Compliance News, 20 April 2024).

What a foreign contractor must arrange

List 3 of the Foreign Business Act restricts architectural, engineering and construction services. A foreign company, or a Thai company with half or more of its shares held by non-Thais, must first obtain a foreign business licence or certificate from the Department of Business Development, assessed separately for each business line. Foreign staff need work permits after arrival. A 2017 ministerial regulation did not lift these rules for construction (Tilleke & Gibbins, 4 August 2017). The nine activities in draft changes approved by cabinet on 12 May 2026 do not include construction (Tilleke & Gibbins, 25 May 2026).

What to send for a first scope

Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether the plant makes drugs or devices, the risk class of each device line, and whether the rooms are sterile or non-sterile. Say whether the building is new or existing.

Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. Certification and testing can be arranged per project.

Who does the site work

Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.

Related guides

• How long does it take to build a cleanroom?
• Cleanroom cost per m²: published ranges by ISO class
• What a cleanroom costs to run: energy, filters and testing
• Building a cleanroom inside an existing building
• Turnkey cleanroom contractor
• Room list builder

Sources

• PIC/S, list of participating authorities (checked 1 November 2026)
• PIC/S, Thailand / Thai FDA accedes to PIC/S (1 August 2016)
• Thai Food and Drug Journal, readiness for PIC/S re-assessment of Thai FDA, volume 33, issue 2 (14 August 2026)
• Baker McKenzie via Global Compliance News, Thai FDA issues regulations on quality systems for medical devices (20 April 2024)
• Tilleke & Gibbins, Engineering, procurement and construction considerations for foreign companies (4 August 2017)
• Tilleke & Gibbins, Thai cabinet advances draft amendments to liberalize nine foreign business activities (25 May 2026)