Thai FDA requires Clinical Evaluation Reports (CERs) as part of the Full CSDT for Class 2-4 medical devices. The new CER guidance released by Thai FDA fully adopts the IMDRF CER framework without technical modification and does not introduce Thailand-specific requirements. While MEDDEV 2.7/1 Rev.4 remains commonly preferred in review practice, this guidance provides summarized requirements and recommendations to assist new manufacturers in preparing CERs for Thai medical device registration. Key requirements from the guidance are noted below.
General Requirements of Clinical Evaluation Report (CER) in Thailand
Before dossier submission, manufacturers must evaluate device characteristics, intended use, target patient populations, residual risk assessment, equivalent device data, pre-market and post-market clinical data, and sources of all available clinical data. These data must prove safety, clinical performance, and effectiveness of the medical device.
Clinical Evaluation Process: 3 Key Stages Following IMDRF Framework
(1) Identification of relevant standards and clinical data
Clinical data obtained from following methods:
- Literature searches (the device itself, equivalent device)
- Clinical Experiences
- Clinical Investigations
(2) Appraisal of obtained clinical data
Appraisal Criteria for evaluators include:
- Data generation/collection techniques
- Bias and confounding factors
- Relevance to device intended use performance and safety
- Device-specific standards and ISO 14155:2020 compliance
- Target patient demographics
- Suitable methodology based on risk level
(3) Clinical Data Analysis
Analysis of each dataset and overall evidence must show that risks are acceptable versus benefits, using either quantitative or qualitative methods. The evaluator then concludes the following aspects:
- Device achieves manufacturer's intended performance
- No unacceptable safety risks to patients or users
- Risk-benefit profile favorable to patients
- Essential Principles requirements met
- Necessity of post-market surveillance or post-approval studies
Evaluator Selection
Evaluators must demonstrate expertise in relevant field and technology of the device supported by documented qualifications and experiences.
Evaluators must also understand research methodology (including biostatistics), and clinical management of target medical conditions.
Leveraging IMDRF-Compliant Clinical Evaluation Reports for Thai FDA Submissions
To demonstrate safety, performance, and effectiveness of Class 2-4 medical devices, applicants must identify relevant clinical data and conduct appropriate clinical data appraisal and analysis. IMDRF-compliant CERs may be directly leveraged for Thai FDA submissions with minimal administrative adjustment.
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