Health Product Control Regulation in Thailand has entered a new era: starting June 2025, all health product imports and exports are managed through a fully digital system jointly enforced by the FDA and Thai Customs.

If you are a business owner, manufacturer, or customs broker, every product now passes through this streamlined, real-time platform: pharmaceuticals, supplements, cosmetics, and medical devices included.

Health product control regulation Thailand FDA Thai customs

Why does this matter right now? Failure to comply with the updated digital requirements can cost companies significant time and revenue, with a single incorrect entry triggering customs holds or penalties.

As regulatory expectations soar, understanding these new standards is essential for risk reduction and predictable market access.

Key Takeaways

  • Thailand’s 2025 Health Product Control Regulation fully digitalizes compliance by centralizing all import and export requirements for pharmaceuticals, medical devices, supplements, cosmetics, herbal products, and hazardous substances in a single electronic framework.
  • Mandatory use of the Thai National Single Window (NSW) streamlines all customs and health product submissions with real-time data sharing between the FDA and Thai Customs for faster, more accurate processing.
  • Digital “License Per Invoice” (LPI) pre-clearance is now required for every health product shipment, making accurate classification and documentation critical to avoid costly customs delays and penalties.
  • Controlled Goods Database minimizes misclassification risk by serving as the authoritative reference for product categories and regulatory guidance, ensuring smoother customs approval.
  • Unlisted or ambiguous health products demand proactive action: submit for official classification, provide comprehensive documentation, and monitor regulatory databases to maintain full compliance.
  • Ongoing quality assurance and reporting are mandatory: businesses must retain records, report adverse events, and meet global standards to ensure readiness for audits and swift product recalls.
  • Integrated surveillance and digital monitoring heighten enforcement: real-time audits, electronic alerts, and cross-agency coordination protect both business operations and public health.
  • E-commerce and cross-border sellers face direct oversight: all online shipments must follow the same digital protocols, with real-time market surveillance removing noncompliant products within 24 hours.

 

How 2025 Health Product Control Changes Oversight

Thailand’s fully digital Health Product Control Regulation, jointly rolled out by the FDA and Thai Customs in June 2025, centralizes oversight and streamlines compliance for all health-related imports and exports.

Compared to the 2017 law, this new framework introduces:

  • Broader scope: now covering pharmaceuticals, medical devices, dietary supplements, cosmetics, herbal products, and hazardous substances
  • Full digitalization: all licensing and reporting are now electronic
  • Unified regulatory control: customs and health authorities use shared data for faster, more accurate decisions

This approach targets three clear objectives for business owners and professionals:

  • Faster import/export workflows by reducing paperwork and site visits
  • Improved consumer protection with real-time verification and audit trails
  • Greater efficiency and predictability for all supply chain stakeholders

For additional regulatory information, visit the official Thai FDA resource.

Core Features of the New Digital Framework

Businesses must use the Thai National Single Window (NSW) platform for all customs and health product submissions.

Key mechanisms include:

  • Controlled Goods Database: a single reference point that eliminates misclassification
  • Mandatory “License Per Invoice” (LPI): digital licensing with required pre-clearance
  • Real-time data sharing: FDA and Customs coordinate instantly, minimizing delays

A single digital mistake can delay shipments or result in costly penalties, underscoring the value of correct data entry.

Handling Unlisted or Ambiguous Products

If a product is unlisted but fits health product definitions, strict protocols now apply.

Required actions for ambiguous cases:

  • Submit for classification guidance through Thai Customs or the FDA
  • Provide comprehensive documentation and request prior licensing
  • Monitor the Customs Controlled Goods Database to stay updated

Proactive classification and documentation are essential for risk reduction and compliance.

Compliance Rules for Manufacturers and Importers

Thailand’s 2025 Health Product Control Regulation requires all manufacturers, importers, and customs brokers to complete key steps before products can enter the marketplace.

Essential compliance tasks include:

  • Electronic documentation of every shipment via the Thai National Single Window (NSW)
  • Accurate product classification aligned with Thailand’s Controlled Goods Database
  • Digital “License Per Invoice” (LPI) submission and pre-clearance notification
  • Correct, multilingual labeling that meets healthcare product standards

Every shipment must be fully documented, licensed digitally, and classified correctly to clear Thai customs under the new framework.

Electronic Submission and Pre-Clearance

To comply, businesses must:

  1. Submit itemized electronic reports for each product via NSW
  2. Synchronize HS/customs codes, LPI permits, and supporting certification
  3. Check status in real-time, addressing flagged discrepancies immediately

Common pitfalls:

  • Misclassifying products in the NSW system
  • Omitting prior licensing for newly listed items

These steps help avoid customs rejections, financial penalties, and shipment delays.

Ongoing Quality Assurance and Reporting

Manufacturers and importers must:

  • Retain shipment documentation for audits
  • Report adverse events or product recalls to Thai FDA
  • Maintain quality assurance systems that align with global requirements: see WHO Guidelines

Thailand’s transparent, digital-first system brings predictability to regulatory compliance. Staying updated, submitting correct digital documents, and investing in robust quality assurance are the most effective ways to streamline market access and protect your business.

Regulatory Authorities Overseeing Product Safety

Thailand’s 2025 Health Product Control Regulation places oversight with the Thailand FDA, Thai Customs, and provincial health offices. These agencies set the requirements for health product regulatory compliance and ensure healthcare product standards across all imported and distributed goods.

Key enforcement mechanisms include:

  • Physical inspections at entry points
  • Random and targeted surveillance of shipments
  • Issuing penalties for misclassification or non-compliance

These authorities also rely on the integrated Controlled Goods Database and digital permitting through the Thai National Single Window, reducing ambiguity and procedural delays.

Benefits of Harmonized Standards for Business and Health

Thailand’s alignment with global healthcare product standards, such as WHO guidelines facilitates:

  • Mutual recognition of certifications
  • More predictable market access
  • Increased consumer confidence in product safety

By enforcing public health standards, these agencies balance commercial interests with safety. For example, a single digital license allows faster clearance while ensuring compliance with local and international laws.

The new system empowers businesses to navigate requirements efficiently while strengthening public health monitoring and product quality.

Post-Market Surveillance in 2025 Regulation

Thailand’s 2025 health product control regulation mandates real-time, nationwide monitoring for every imported or distributed health product.

Regulatory authorities including the Thailand FDA, Customs, and provincial health offices, use risk-based inspection protocols, targeted sampling, and automated data analysis to pinpoint compliance risks fast.

Key strategies include:

  • Continuous surveillance of licensed products in distribution channels
  • Data-driven risk analysis to trigger focused inspections
  • Decentralized monitoring networks spanning local and provincial agencies

These measures enable swift identification of noncompliant, substandard, or unauthorized products.

Digital Tools for Monitoring and Consumer Protection

Cutting-edge digital tools power online market surveillance and real-time reporting.

Essential innovations:

  • API-integrated e-market scanning for detecting illegal or misclassified products
  • Automated alerts to e-commerce partners for high-risk listings
  • Predictive analytics to foresee and prevent emerging product risks

Example: Over 8,000 SKUs are reviewed monthly through Thai FDA’s e-market surveillance portal, with noncompliant listings flagged for removal within 24 hours.

Businesses should utilize the official Thai FDA e-market surveillance site for compliance updates.

Key Challenges in 2025 Health Product Control

Navigating Thailand’s new health product control regulation in 2025 requires businesses to address three core challenges immediately: rapid digital health innovation, the complexity of cross-border e-commerce, and the speed of product turnover.

Frequent regulatory changes mean companies must adapt quickly or risk compliance failures. For example, the rapid rise of digital therapeutics and personalized supplements has outpaced traditional review processes, creating uncertainty.

Key ongoing challenges include:

  • Harmonizing local regulations with global healthcare product standards
  • Ensuring transparent supply chains to prevent entry of noncompliant goods
  • Balancing data privacy with mandatory electronic documentation under Thai NSW

A single misclassification or delayed electronic permit can result in customs rejections or costly penalties, highlighting the need for continuous regulatory monitoring.

Businesses can reduce risk and costs by:

  • Implementing proactive compliance management systems for real-time regulatory intelligence
  • Leveraging digital tools to automate workflows, audit documentation, and synchronize licensing data
  • Partnering with industry associations to stay updated on new standards and advocate for practical changes

Staying agile and informed is the most effective way to navigate Thailand’s evolving health product regulatory landscape.

FAQ: 2025 Health Product Control Regulation

Digital Licensing and Product Classification

  • All health products within Thailand FDA’s regulatory scope, including items not specifically listed, must have License Per Invoice (LPI) digital licensing via the Thai National Single Window (NSW) system before customs clearance.
  • Accurate product classification and documentation in the NSW are mandatory. Errors or missing information can result in:
  • Customs rejection
  • Import/export delays
  • Regulatory penalties or seizure

E-Commerce and Cross-Border Compliance

  • The updated framework directly impacts online sellers. The Thai FDA, using advanced electronic tools, monitors and removes noncompliant health products from marketplaces.
  • For cross-border e-commerce, operators must:
  • Submit complete electronic records for every shipment
  • Maintain real-time reporting and post-market surveillance
  • Ensure compliance aligns with all Thai FDA requirements

Effective digital oversight means that every stakeholder must prioritize real-time accuracy, documentation quality, and ongoing monitoring to keep operations moving smoothly.

Conclusion

Protect your operations by adopting digital documentation, verifying every classification, and staying engaged with ongoing regulatory updates. Strengthen your compliance protocols and audit trails to minimize risk and ensure resilient growth in Thailand’s evolving market.

For tailored strategies and seamless compliance, contact us. Themis Partner simplifies digital licensing, regulatory monitoring, and end-to-end documentation allowing you to move confidently through every customs checkpoint.