Medical Device Registration Thailand

Medical Device Registration Thailand

Medical Device Registration in Thailand: Streamlined Processes for Global Manufacturers
Qserve specializes in supporting the registration of medical devices and the maintenance of registered products in the Thai Food and Drug Administration (TFDA) database, managed by the Medical Device Control Division. Our team is well-versed in the Medical Device Registration Thailand protocol and is experienced in preparing the required documentation to register medical devices in Thailand legally.

As a leading medical device market in Southeast Asia, Thailand has harmonized its regulatory requirements with global standards, aligning with frameworks such as the International Medical Device Regulators Forum (IMDRF), the Association of Southeast Asian Nations (ASEAN), and the European Union (EU). This harmonization simplifies the registration process and enhances the appeal of the Thai market for international medical device manufacturers.

Streamlined Registration Pathways
Thailand offers several expedited pathways to facilitate market entry for global players:

• Concise Evaluation: A registration approach that leverages reference agency approvals or WHO prequalification.
• Reliance Program: A streamlined process that relies on approvals from Health Science Authority (HSA) Singapore.
• WHO CRP for IVD: A program tailored to in vitro diagnostics, enabling faster market entry.

This harmonization effort has significantly enhanced the allure of the Thai market for international medical device manufacturers. Initiatives like Concise Evaluation, Reliance Program, and the WHO CRP for IVD have streamlined the process, creating a more welcoming environment for global players.

Medical Device Registration Thailand

Entering the Thailand medical device market can be a complex process, whether it is your first market or you are leveraging evidence from overseas approvals. Qserve provides expert guidance to simplify the Medical Device Registration Thailand process, ensuring compliance and a faster route to market.

How Qserve Supports Your Registration Process

• Comprehensive Documentation Preparation: From the start, we assist with preparing and submitting technical documentation tailored to Thailand’s regulatory requirements.
• Gap Analysis for Existing Documentation: If you already have technical documentation, we compare it with Thailand Medical Device Regulations to identify overlaps and missing elements. This ensures compliance and eliminates unnecessary delays.

• Country-Specific Compliance: We help you understand the key differences between Thailand’s requirements and EU/US medical device regulations, minimizing lead time and streamlining the process.
• Local Network in Thailand: With an established regional network, Qserve facilitates seamless communication with the Thai Food and Drug Administration (TFDA), ensuring a smooth registration process.

Benefits of Qserve engagement

Qserve is a leading regulatory consulting firm specializing in medical devices and in vitro diagnostic (IVD) quality and regulatory affairs services.

• Worldwide Market Access: We help clients achieve and maintain market access across the globe, including in Thailand.
• Deep Understanding of Regulatory Landscapes: Our experienced team of regulatory and quality experts navigates the complexities of Thai FDA regulations, ensuring compliance at every step.
• A Practical Approach: Qserve adopts a hands-on, practical approach to guide you through the entire regulatory process, from documentation preparation to post-market surveillance.