ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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The Medical Devices Market in Thailand
Valued at US $6.9 Billion (est.)
Growing at a CAGR of 7.5%
One of largest single use medical device exporter in ASEAN
$5.99 Billion (est.) Medical Devices Imported
Medical devices manufactured or imported into Thailand may serve either commercial or non-commercial purposes. For medical devices manufactured with in Thailand or imported into Thailand for commercial purposes, there are three distinct review pathways available to secure approvals from the Thai FDA:
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Full evaluation
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Concise pathway
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Reliance program
Regulatory Authorities
Class
Risk
Registration
Listed Medical devices
Minimal risk
Class 1
Low to Moderate risk
Class 2
Notified Medical devices
Moderate to High risk
Class 3
High risk
Class 4
Notified Medical devices
Licensed Medical devices
Classification
Process
Documents Required for Registration of Medical Devices in Thailand
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Establishment license number
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Letter of Authorization for a juristic person applicant
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Device description, labelling, IFU, executive summary, manufacturing and product owner information
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Safety and demonstrative conformity data
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Calibration test
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QMS Certification
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Declaration of conformity, market history, safety
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Declaration letter describing intended use, indication, packaging, labels and instruction for use
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Power of attoney of importer
Medical Devices Registration Services in Thailand
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Marketing Authorisation Holder (MAH) Services
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Gap Analysis
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Regulatory Intelligence and Strategy
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Consultation and Meeting
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Technical File Preparation and Submission
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Quality Management System Implementation
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Audit Support
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Quality Training
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Response to Queries
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Clinical Evaluation and Post Marketing
Evaluation
Determine if the product is medical device
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In case of any ambiguity, submit product classification application to Thai FDA
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Classify the emdical device as Class 1, 2, 3, or 4
Determine if the device is subjected to Listing or Notification or Licensing
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Determine the submission document requirement
Submit to Thai FDA for review and approval
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Review of the application timeline is 200 days for listed devices and 300 for notified and licensed devices
Explore how we can help your MedTech Product launch in Thailand.
Services Offered
Market Size & Landscape Analysis
KOL Analysis
Price Sensitivity Analysis
Distributor Search and Licensing
Market Access
Marketing Authorization Holder
Post Market Maintenance
Post Market Surveillance Query Responses
Authorized Representative
Regulatory Intelligence & Strategy, Gap Analysis, Remediation and Submission
Regulatory Affairs
QMS Implementation
ISO 13845 Consulting, 21 CFR
820, SOP Development, Audits
Quality Management
Clinical evaluation reports (MEDDEV 2.7.1)
Clinical investigation protocols and reports
Medical Writing & Medical Review
Clinical Services
Contact our team
With Our Expert Regulatory Team based at our Regional Office in Malaysia, Artixio can act as your Authorized Representative and help you launch your products successfully in the country from Strategy, Registration to Post Market Support.
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