Thai FDA Clinical Investigation & CRO Regulatory Support

Clinical Investigations for Medical Devices in Thailand

Clinical investigations for medical devices in Thailand are regulated by the Thai Food and Drug Administration under specific procedural and ethical requirements.

Not all devices require clinical investigations in Thailand.
However, when clinical data are required, the regulatory process must be carefully structured to avoid delays, rejections, or ethical non-compliance.

MedGate provides regulatory support for clinical investigations, as independent Thai FDA license holder, working alongside CROs, manufacturers, and ethics committees.

When Clinical Data Are Required by Thai FDA

Thai FDA may require clinical data depending on:

  • device classification and risk level

  • novelty of the technology

  • intended use and claims

  • availability of equivalent devices

  • existing clinical evidence

Clinical investigations may be required for:

  • new or innovative medical devices

  • high-risk devices

  • products without sufficient clinical history

  • expanded indications or claims

MedGate performs a regulatory clinical assessment to determine whether local clinical investigations are required or can be avoided.

Regulatory Pathway for Clinical Investigations in Thailand

Clinical investigations in Thailand involve:

  • Thai FDA authorization

  • ethics committee approval

  • site selection and oversight

  • compliance with Good Clinical Practice (GCP)

  • post-study reporting

Regulatory submissions must be aligned with:

  • Thai FDA expectations

  • international clinical standards

  • local ethical and administrative requirements

MedGate supports the entire regulatory pathway, ensuring proper coordination between all involved parties.

Role of CROs in Thailand

Clinical Research Organizations (CROs) play a key operational role in:

  • study management

  • site coordination

  • monitoring

  • data collection

  • reporting

However, CROs do not replace regulatory responsibility.

MedGate operates as the regulatory interface, ensuring that CRO activities:

  • comply with Thai FDA requirements

  • align with the approved regulatory strategy

  • remain consistent with the overall registration plan defined during Thai FDA Medical Device Registration

MedGate CRO Regulatory Support

MedGate does not act as a CRO.

Our role is to provide independent regulatory oversight, including:

  • clinical regulatory strategy definition

  • Thai FDA submissions for clinical investigations

  • coordination with CROs and ethics committees

  • regulatory communication with authorities

  • integration of clinical data into registration dossiers

This separation ensures:

  • regulatory independence

  • clear allocation of responsibilities

  • reduced compliance risk

Ethics Committees and Local Requirements

Clinical investigations in Thailand require approval from recognized ethics committees.

Ethics submissions must address:

  • patient safety

  • informed consent

  • risk-benefit analysis

  • data protection

  • local ethical considerations

MedGate ensures that regulatory and ethical submissions are:

  • consistent

  • complete

  • aligned with Thai FDA expectations

Clinical Data Integration into Registration

Clinical data generated in Thailand or abroad must be properly:

  • structured

  • analyzed

  • presented

  • justified

Incorrect integration of clinical data may result in:

  • additional data requests

  • extended review timelines

  • rejection of the registration

MedGate manages the regulatory use of clinical data within the overall Thai FDA registration strategy.

Who Needs Clinical Regulatory Support

Clinical regulatory support is recommended for:

  • manufacturers of medium and high-risk devices

  • companies introducing innovative technologies

  • manufacturers expanding claims or indications

  • companies entering Thailand with limited clinical history

Early regulatory planning significantly reduces downstream risk.

Start with a Clinical Regulatory Assessment

Not all clinical investigations are mandatory, and not all CRO proposals are appropriate.

MedGate provides a preliminary clinical regulatory assessment to:

  • determine Thai FDA expectations

  • evaluate the necessity of clinical investigations

  • define the most efficient regulatory pathway