Medical Device Classification in Thailand

Medical device classification in Thailand is based on a risk-oriented regulatory system established by the Thai Food and Drug Administration (Thai FDA).
Correct classification determines the applicable registration pathway, documentation requirements, and regulatory obligations throughout the product lifecycle.

This page explains the Thai FDA medical device classification framework and its role within the broader medical device regulatory system in Thailand (anchor).

Overview of the Thai FDA Classification System

The Thai FDA classifies medical devices according to:

  • Intended use

  • Level of invasiveness

  • Duration of contact

  • Potential risk to patients and users

Classification is not a marketing decision but a regulatory determination that directly affects compliance strategy.

Main Medical Device Categories in Thailand

Thai FDA regulations define several regulatory categories, including:

  • Low-risk medical devices

  • General medical devices

  • Notified medical devices

  • Licensed medical devices

Each category corresponds to a different level of regulatory oversight within the medical device registration process in Thailand.

Relationship Between Classification and Registration Pathways

Device classification determines whether a product requires:

  • Simple notification

  • Listing

  • Full license-based registration

Incorrect classification may lead to submission rejection, regulatory delays, or post-market enforcement actions.

For this reason, classification is a critical prerequisite to any Thai FDA medical device registration.

Classification and Technical Documentation

The level of technical documentation required by the Thai FDA is directly linked to device classification.

Higher-risk devices generally require:

  • More detailed technical files

  • Clinical or performance data

  • Enhanced post-market obligations

Proper alignment between classification and documentation reduces regulatory uncertainty and improves submission outcomes.

Regulatory Interpretation and Practical Implications

Although classification rules are defined by regulation, their application often requires regulatory interpretation based on precedent, guidance, and Thai FDA practice.

Manufacturers may consult medical device regulatory services in Thailand for practical classification assessments aligned with Thai FDA expectations.