Thai FDA Medical Device Registration
Ensure your medical device meets Thailand's regulatory standards with our expert Thai FDA registration services. We provide fast, efficient, and fully online solutions, guiding you through every step of the process for smooth market entry and compliance.
A medical device under Thai FDA regulations is any instrument, apparatus, implement, machine, appliance, implant, reagent, or similar article, whether used alone or in combination, intended for medical purposes. These purposes include diagnosis, prevention, monitoring, treatment, or alleviation of disease or medical conditions, as well as supporting or sustaining life. Medical devices are designed to work through physical means, such as mechanical or electrical actions, and do not achieve their intended purposes primarily through chemical action or metabolic processes within the body.
Class 1 Medical Device Registration
Class 1 medical devices require a straightforward registration process with the Thai FDA. Key documents include the product description, labeling, technical specifications, and a certificate of free sale or GMP certification.
Process
1. Prepare Documentation: Gather all required documents for submission.
2. Submit to Thai FDA: We submit your complete documentation for review.
3. FDA Approval: If complete, approval is typically granted within 3 to 6 weeks
By ensuring your documents are complete, we can meet the FDA's timeline and ensure a smooth registration process.
Class 2/ 3 Medical Device Registration
Class 2 and 3 medical devices, considered medium-risk, require a more detailed review by the Thai FDA. Key documents include the product’s technical specifications, labeling, certificate of free sale, GMP certificate, and risk management documentation.
Process
1. Document Preparation: Collect all necessary documents, including risk analysis and quality standards.
2. Submission to Thai FDA: We submit complete documentation for FDA review.
3. Approval: If complete, approval generally takes 6 to 8 months or shorter in some cases (e.g. abridge)
With fully prepared documentation, we ensure timely submission to meet FDA timelines for a seamless registration process.
Class 4 Medical Device Registration
Class 4 medical devices are high-risk products that require the most rigorous review by the Thai FDA. Key documents include detailed technical specifications, clinical trial data, risk management files and quality control procedures.
Process
1. Prepare Documentation: Gather all technical, clinical, and quality-related documents.
2. Submit to Thai FDA: We handle the submission of complete documents to the FDA.
3. FDA Approval: Approval typically takes 8 to 12 months, depending on the complexity of the device. Time can be shorter in some cases.
With comprehensive documentation, we ensure timely submission to meet the Thai FDA’s approval timeline.
IVD (In Vitro Diagnostic) Registration
IVD devices require registration with the Thai FDA to ensure safety and efficacy. Key documents include product specifications, clinical validation data, risk management files, labeling, a certificate of free sale, and GMP certification.
Process
1. Prepare Documentation: Collect all necessary clinical, technical, and labeling documents.
2. Submit to Thai FDA: We submit your complete documentation for FDA review.
3. Approval: Registration typically takes 3 to 6 months, depending on the device complexity.
With accurate and complete documentation, we ensure a smooth and timely registration process with the Thai FDA.