Regulatory compliance Thailand
Thailand Medical Device Regulations
Thailand's Medical Device Regulations are governed by the Thai Food and Drug Administration (TFDA), the official government agency responsible for regulating medical devices, including in vitro diagnostics (IVDs). The Medical Device Control Division (MDCD), operating under the TFDA, handles the review and approval of medical device notifications and licenses.
Key Regulations and Submission Guidelines
- Medical Devices Act, B.E. 2551 (2008) and (No. 2), B.E. 2562 (2019) serve as the primary legal framework for medical devices and IVDs in Thailand.
- Manufacturers must prepare and submit technical dossiers following the harmonized Common Submission Dossier Template (CSDT) guidelines, ensuring consistency and compliance with global standards.
How Qserve Supports Compliance in Thailand
Qserve offers expert guidance and services to help manufacturers meet Thailand's Medical Device Regulations. From preparing compliant technical dossiers to managing regulatory submissions, our team ensures a smooth process for market access.
Registration routes Thailand
Registration process
Any individual or organization intending to manufacture or import medical devices for sale in Thailand must apply for product registration with the Thai Food and Drug Administration (Thai FDA). The Thai FDA offers three distinct registration pathways:
Full Evaluation
The full evaluation pathway follows the standard listing, notification, or licensing process, depending on the device’s risk classification. This pathway ensures compliance with the risk-based classification rules outlined by the Thai FDA.
Concise Pathway
The Concise Pathway is an expedited route that recognizes approvals from reference agencies or leverages the World Health Organization (WHO) prequalification. This approach shortens the review time, providing a faster option for market entry when these conditions are met.
Reliance Program
The Reliance Program is another fast-track option, relying on Singapore’s Health Science Authority (HSA) approvals. This program significantly accelerates the medical device registration process for devices already approved in Singapore.
These expedited pathways reflect the Thai FDA's commitment to streamlining market access for medical devices while maintaining regulatory compliance.on process.
Additional Regulatory Requirements
Quality and clinical requirements
Compliance with Thailand Medical Device Regulations requires manufacturers to meet specific quality and clinical requirements, depending on the device classification.
Clinical Evaluation Requirements:
Class I Devices: Exempt from clinical evaluation.
Class II, III, and IV Devices: A clinical evaluation report must be submitted as part of the regulatory submission process. Based on clinical data, this report ensures the device's safety and effectiveness.
Quality Management System (QMS) Requirements:
Class II, III, and IV Devices must meet the quality and safety standards required by the Thai FDA. Manufacturers must implement a Quality Management System (QMS), such as compliance with ISO 13485 or other country-specific GMP standards.
These requirements are essential for ensuring the safety, performance, and regulatory compliance of medical devices in the Thai market.
