Medical Device Registration Thailand

Qserve is your regulatory consultancy partner for medical device registration services in Thailand.
Medical Device Act/Ordinance B.E.2562 (2019) (Issue2) Regulation

Medical Device Registration Thailand

Qserve supports the registration of medical devices and the maintenance of registered products in the Thai Food and Drug Administration database, the Medical Device Control Division. We understand the requirements for the Medical Device Registration Thailand protocol and are experienced in preparing the required documentation to register a medical device legally in Thailand.

Thailand is the prominent medical device market in Southeast Asia, and the Thai Food and Drug Administration (TFDA) has diligently worked to harmonize the requirements and the necessary documentation for registering medical devices in Thailand with other nations, particularly the members of the International Medical Device Regulators Forum (IMDRF), Association of Southeast Asian Nations (ASEAN), and the European Union (EU). Local Representation/Medical Device Registration in Thailand.jpg?preset=content

This harmonization effort has significantly enhanced the allure of the Thai market for international medical device manufacturers; through initiatives like Concise Evaluation, Reliance Program, and the WHO CRP for IVD, the process has been streamlined, creating a more welcoming environment for global players.

Regulatory Compliance in Thailand

Medical Device Registration Thailand

Is Thailand your first market to enter, or can you lodge evidence from overseas approvals? Qserve can support the preparation and submission of your technical documentation from the time of initiation. When you already have technical documentation for your device, we compare your existing documentation and supporting evidence to the Thailand requirements to identify the overlap and missing parts that need to be added. Together, we determine the main differences between the country-specific requirements and EU/US medical device regulations to reduce your lead time in the market. Qserve has a local network in Thailand that could communicate well with TFDA.

Benefits of Qserve engagement

  • Qserve is a leading regulatory consulting firm offering medical devices and in vitro diagnostic regulatory and quality affairs services.
  • We specialize in helping clients achieve and maintain market access around the world.
  • Our team of experienced regulatory and quality experts have a deep understanding of the regulatory landscape and can help manufacturers navigate the complex requirements.
  • Qserve uses a practical approach to support you every step of the way. 

Do you need assistance with medical device registration in Thailand or a go-to-market strategy?

Qserve is your trusted partner for market access in Thailand.

Contact us

Market access to Thailand

Do you want to learn more about market access regulation in Thailand?

We help you with a quick overview of:

  • Medical Device Act/Ordinance B.E.2562 (2019) (Issue2)
  • The Thailand medical device registration process
  • Classification requirements
  • Regulatory requirements
  • Registration routes (general or customized to your device)
  • Important guidance links

Market access Thailand

How Qserve can help

  • Regulatory market access strategy
  • Registration support in Thailand
  • Technical documentation gap analysis
  • Classification assessment
  • The Common Submission Dossier Template (CSDT) support
  • Establishment importer license
  • Translations label and IFUs based on requirements
  • Build compliant QMS
  • Gap analysis
  • Risk management
  • Clinical evaluation
  • Post-market surveillance
  • Vigilance reporting
  • Sterilization Test Report (sterile device)
  • Measurement Test Report (measuring device)

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