IVD Medical Device Registration in Thailand
IVD Medical Device Registration in Thailand
Our experienced regulatory affairs specialists provide comprehensive support, from initial classification and submission to post-market compliance, ensuring your IVD devices meet all regulatory requirements by the Thai government.
IVD Medical Device Registration Support for Compliance Access – Thailand
Thailand is experiencing increasing awareness of the importance of early disease detection and prevention, leading to growing demand for diagnostic testing and advanced medical technologies. The Thai Food and Drug Administration (Thai FDA) regulates the registration of in-vitro diagnostic (IVD) devices to ensure their safety, efficacy, and quality before they are introduced to the market.
At Andaman Medical, our regulatory affairs specialists provide comprehensive support throughout the IVD registration process. From initial device classification and regulatory submission to post-market compliance, we help ensure your IVD devices meet the regulatory requirements established by the Thai government.
Why Register Your IVD Medical Device in Thailand?
Registering your IVD device in Thailand enables manufacturers to access one of Southeast Asia’s expanding healthcare markets. Compliance with national regulatory requirements ensures that diagnostic devices can be legally distributed while supporting the country’s growing demand for reliable diagnostic technologies.
Registering your IVD device in Thailand offers numerous strategic advantages:
Expanding Market Opportunities
Expanding Market Opportunities
Thailand’s IVD market is one of the largest in Southeast Asia, showing strong growth due to the increasing demand for advanced diagnostic solutions. By registering your IVD device in Thailand, you gain access to a market that is continuously expanding, driven by the need for improved healthcare services and innovative diagnostic technologies.
Regulatory Compliance and Market Credibility
Regulatory Compliance and Market Credibility
Registering your IVD device with the Thai Food and Drug Administration (Thai FDA) ensures compliance with local regulations, enhancing your product’s credibility and acceptance in the market. Compliance with stringent regulatory standards demonstrates your commitment to safety, efficacy, and quality, which can significantly boost your reputation among healthcare providers.
Strategic Location in Southeast Asia
Strategic Location in Southeast Asia
Thailand’s strategic location serves as a gateway to other Southeast Asian markets. Successful registration and commercialization of IVD devices in Thailand can facilitate expansion into neighboring countries, leveraging the established regulatory and distribution frameworks.
Registration Process Overview
Here’s a step-by-step overview to navigating the IVD registration process in Thailand:
Classification
Submission
Evaluation
ApprovalClassification
As of February 2021, Thailand has updated its classification categories for medical devices, including both IVD and non-IVD products, from three to four risk categories:
- Previous Classification: General, Notified, Licensed
- New Classification:
- Class 1 (Listing): March 17, 2021
- Class 2 to 4 (Notified and Licensed): February 15, 2021
Medical Device Grouping in Thailand
The new regulations allow all Classes 1, 2, 3, and 4 to benefit from grouping under one registration submission:
- Single
- Family
- System
- Set
- IVD Test Kit
- IVD Cluster
Submission
Documentation required for registration includes:
- Device description
- Pre-clinical studies
- Device labeling
- Instructions for use
- Risk analysis
- Existing regulatory approvals or market authorizations
- Manufacturer’s ISO 13485 compliance
All registrations must be submitted online via the Pre-submission and E-submission system. The accepted language for submission is English. Applications are subject to the Medical Device Act, B.E. 2551 (2008) and its amendment, B.E. 2562 (2019).
Evaluation
Once submitted, the Thai FDA will evaluate the documentation. If the documentation meets the requirements, the Thai FDA will issue the appropriate certificate (Listing, Notification, or Licence).
The Thai FDA might require additional documents and reevaluate the submission.
Approval
Depending on the product classification and the validity of existing certificates, the approval process varies:
- Class 1 Listing Medical Devices:
- Products with less than 1 year of validity remaining as of February 15, 2021, require partial submission for listing.
- Products with more than 1 year of validity remaining or new products require full submission before importation.
- Class 1 Listing Certificate is valid for 5 years.
- Classes 2 & 3 Notified Medical Devices and Class 4 Licensed Medical Devices:
- Certificates are valid for 5 years.
Successful submissions result in the issuance of the relevant certificate, while rejected submissions may require additional documentation or resubmission.
Why Choose Andaman Medical?
Our expert guidance through the region's evolving regulatory landscape ensures your product remains compliant, allowing you to bring your products to market efficiently and effectively.
Experienced In-house Team
across 7 Southeast Asian Countries
Full Control with Seamless
Distributor Switching
Singular Point of Contact
for Registration
QMS Compliance
ISO 13485 Certified
Overcome Language Barrier
With Multilingual Local Team
One-Stop Access
into Southeast Asia