Medical Device License Amendments in Thailand: A Complete Guide by Device Class
Registered a medical device in Thailand and need to make changes? Post-market amendments to Thai medical device licenses follow a structured process defined by the Thai FDA — and the rules differ significantly depending on your device class and the nature of the change. This guide breaks it all down clearly.
Important: Making the wrong amendment, or submitting it under the wrong category, can invalidate your license or trigger a compliance review. If in doubt, always consult a licensed regulatory affairs firm before filing.
Quick Reference: medical device license amendments Types by Class
| Device Class | Auto-Approved Changes | Approval Required (Expert Review) |
|---|---|---|
| Class 1 – J.N. 3 | Grouping reductions, product owner name (merger), manufacturer name/location (same site), ISO 13485 declaration updates | Adding devices to grouping, label/documentation changes (no intent change), accessories, software additions |
| Class 1 – J.N. 4 | Import/manufacturing location changes, software modifications (no performance impact) for GMD, AMD and IVD | Manufacturing facility/process/QMS changes, labeling changes (warnings, indications, contraindications), material/component specification changes |
| Class 2, 3, 4 | QMS scope changes (no impact on devices), import/manufacturing location, certification body changes, ISO 13485 updates (same facility) | Manufacturing process, sterilization, design, labeling, materials, software, product listing corrections, and more |
Class 1 Medical Devices – J.N. 3 Amendments
Changes That Do Not Require Review
- Reducing the number of registered devices within a grouping
- Product owner name change due to a corporate merger
- Name and location of the product owner (original manufacturer)
- Overseas manufacturer name/location change — only where the physical location is unchanged
- Updated declaration of conformity, such as renewal of ISO 13485 certification
Changes Subject to Academic Review
- Adding devices of the same design to an existing grouping
- Adding devices or software that do not affect performance characteristics or product specifications
- Adding accessories to the main medical device
- Label or documentation changes that do not alter the intended use or indications
Class 1 Medical Devices – J.N. 4 Amendments
Changes That Do Not Require Review
- Changes to import or manufacturing location information where the establishment has changed
- Software modifications for GMD/AMD devices — only where performance and safety are unaffected
- Software modifications for IVD devices — only where performance and safety are unaffected
Changes Subject to Academic Review
- Manufacturing changes: Adding, removing, or changing overseas manufacturers (same legal manufacturer/product owner); sterilization facility changes where the process and requirements remain unchanged
- Labeling changes: Adding or changing warnings, precautions, contraindications, or adverse events; reducing indications; modifying text without changing the main idea; changes that do not affect efficacy or safety
- Material changes: Modifying non-biological material formulas, coatings, or coating techniques for devices in contact with body tissues/fluids or absorbed by the body — without affecting performance specifications
- Product listing: Correcting typographical errors; changes where the product code remains the same device
- Method of use: Modifications that affect performance and safety, including changes to the intended user
Class 2, 3, and 4 Medical Device License amendments
Higher-risk device classes are subject to more rigorous documentation requirements. All amendments require case-by-case analysis, and many require full expert academic review.
Changes That Do Not Require Review
- Reducing the number of registered devices within a category
- QMS certification scope changes that do not affect registered devices
- Import or manufacturing location changes
- Changing QMS certification body without altering the scope
- Updating ISO 13485 certification at the same production facility
Changes Subject to Academic Review
Manufacturing Facility, Process, or QMS
- Modifying manufacturing processes that affect performance or safety
- Modifying sterilization methods and processes
- Adding, removing, or changing overseas manufacturers (same legal manufacturer)
- Sterilization facility changes where the process and specific requirements are unchanged
- Altering manufacturing processes without affecting effectiveness or safety
Product Listing Changes
- Adding medical equipment or devices with the same design to the list
- Adding devices or software not affecting performance characteristics or product specifications
- Adding accessories to the main device
- Correcting typographical errors in product or accessory listings
- Product code changes where the same device is maintained
- Product owner name or address changes (without changing the overseas manufacturer location)
Labeling and Documentation Changes
- Adding or changing indications for use
- Adding contraindications, warnings, or precautions
- Removing or revising contraindications, warnings, or precautions
- Reducing indications
- Method of use changes that affect performance, safety, or intended user
- Text changes that do not alter the main idea
- Label changes without affecting efficacy or safety
Design and Specification Changes
- Modifying control mechanisms, operating principles, design, specifications, or performance characteristics — without changing the assay principle
- Design changes that do not affect performance or safety
Software Changes (GMD/AMD and IVD)
- Software modifications affecting performance, processing time, or specifications
- Software changes not affecting performance or safety
- For IVD: modifications affecting processing conditions and analyzer specifications
Material and Component Changes
- Modifying drug concentration or specifications of medicinal substances in medical devices
- Modifying shielding materials in ionizing radiation devices
- Non-biological material formula or coating changes — for body contact use — with or without change of manufacturer, where body contact characteristics differ or remain the same
- Modifying the type, source, process, or supplier of biological materials without altering their intended purpose
- Amending supplier lists for non-biological materials (excluding medicinal substances and biological materials) without affecting performance specifications
- For IVD: modifying key chemical or biological components affecting performance specifications but not design specifications
Need to Amend Your Medical Device License in Thailand?
Siam Development is a boutique regulatory firm and the pioneering license-holding operator in Thailand. We handle medical device license amendments for Class 1 through Class 4 devices — ensuring the right submission type, the right documentation, and no costly errors.
We register, we hold, we manage. You focus on your business.
Summary
Article Name
Medical Device License Amendments in Thailand
DescriptionRegistered a medical device in Thailand and need to make changes? Post-market amendments to Thai medical device licenses follow a structured process defined by the Thai FDA — and the rules differ significantly depending on your device class and the nature of the change. This guide breaks it all down clearly.
Author
Diego Sala
Publisher Name
Siam Trade Development Co., Ltd.
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