The Medical Device Control Division of the Thai Food and Drug Administration (Thai FDA) has published on its official website the change application procedures and related regulatory requirements for medical devices, together with the updated change management rules and system operation manual. This update focuses on the post-registration change application routes, change classification, review timelines, deficiency (correction) requirements, and official fees.
Official source: https://medical.fda.moph.go.th/press-release/change_c2-4/
1. Change Application Procedure
According to the change application page published on the official Thai FDA website, medical device changes must be handled through the route corresponding to the type of the original registration document.
1. Class 1: Listing Medical Device
For medical devices that have already obtained a listing notification, operators may submit change applications through the Skynet system.
2. Class 2-4: Detailed Notification / License
For medical devices that have already obtained a Detailed Notification certificate or a License, the corresponding change application procedure must be followed.
The original procedure published by the authority mainly consists of the following stages:
Step 1: Submit the change application
The applicant submits the change application together with the corresponding supporting documents.
Step 2: Completeness screening of documents
The FDA checks whether the application documents are complete and meet the requirements.
- If the documents are incomplete, the applicant is notified to revise or supplement them.
- If the documents meet the requirements, the application status moves to the accepted stage.
Step 3: Determine whether external expert evaluation is required
Based on the subject of the application and the technical documentation, the FDA determines whether the application needs to be submitted to external experts for evaluation.
- External experts not required: the FDA continues the review.
- External experts required: the application enters the expert evaluation procedure, and related deficiency (correction) items are handled according to the evaluation opinions.
Step 4: Technical review and approval
After document screening or expert evaluation is completed, the FDA consolidates the review results and submits them to the corresponding approval procedure.
Step 5: Approval and payment
After approval by the authorized officer, the applicable fees are paid as required by the system, and the application status is updated to Approved.
2. Three Handling Routes Clarified
According to the official explanation, change applications are divided into three handling routes:
1. AUTO APPROVE
For changes that meet the auto-approval criteria, approval is completed automatically by the system without entering the routine technical documentation evaluation procedure.
2. MAJOR CHANGE
Technical documentation evaluation is required. The application may enter the approval procedure only after review by FDA officers or external experts.
3. MINOR CHANGE
A corresponding evaluation is likewise required based on the change item. Whether external experts need to be involved depends on the content of the application and the review arrangement.
3. Changes Already Approved by a Reference Country: Separate Review Route
The Thai FDA has set up a separate review timeline for changes that have already been approved by a Reference Country.
According to the official diagram, there are two main scenarios:
| Change application scenario | Review timeline | External expert evaluation | Number of corrections | Correction period |
|---|---|---|---|---|
| Adding no more than 10 medical device items, or other Major or Minor changes | 15 working days | Not required | 1 time | 5 working days |
| Adding more than 10 medical device items | 35 working days | Not required | 1 time | 5 working days |
How are added product items classified as Major or Minor?
The official diagram also explains some scenarios of added product items:
| Change item | Classification |
|---|---|
| Adding medical device product items | Major |
| Adding medical device items using the same design (Same Design) | Major |
| Adding medical device or software items that do not affect product performance characteristics or product specifications | Minor |
| Adding accessories of the main medical device | Minor |
It should be noted that the above classification only covers the items listed in the official diagram. Actual submissions should still be judged in light of the specific product situation and the content of the change. For changes already approved in a reference country, companies should prepare the corresponding approval evidence in advance and confirm whether they meet the requirements of the Thai FDA reference country approval route.
4. Changes Not Approved by a Reference Country: Review Timeline Based on the Number of Changes
If the change has not yet been approved by a reference country, the review timeline is determined by the number of Major Changes and Minor Changes, and by whether external expert evaluation is required.
1. Review timelines for different numbers of changes
| Number of change items | Without external experts | With external experts |
|---|---|---|
| 1 Major, or 1-3 Minor | 15 working days | 30 working days |
| 2-3 Major, or 4-9 Minor | 35 working days | 55 working days |
| 4-5 Major, or 10-15 Minor | 50 working days | 70 working days |
| 5 or more Major, or 16 or more Minor | 65 working days | 85 working days |
2. Conversion between Major and Minor counts
The official document specifically notes that 3 Minor Changes are converted into 1 Major Change.
The diagram also lists examples of different combinations:
| Change combination | Corresponding review tier |
|---|---|
| 5 Minor, no Major | Tier 2 |
| 3 Minor + 1 Major | Tier 2 |
| 11 Minor, no Major | Tier 3 |
| 3 Minor + 3 Major | Tier 3 |
| 17 Minor, no Major | Tier 4 |
| 3 Minor + 4 Major | Tier 4 |
Therefore, when a single application involves multiple changes, the numbers of Major and Minor changes must be calculated together, and the review timeline cannot be determined based on only one of the change types.
3. Number and period of corrections
The updated diagram further clarifies the number and period of corrections raised by officers and external experts during the review process.
| Review tier | Without experts: number of corrections | Without experts: correction period | With experts: number of corrections | With experts: correction period |
|---|---|---|---|---|
| Tier 1 | 1 time | 5 working days | 1 time | 5 working days |
| Tier 2 | 1 time | 10 working days | 1 time | 10 working days |
| Tier 3 | 1 time | 10 working days | 1 time | 10 working days |
| Tier 4 | 1 time | 10 working days | 1 time | 10 working days |
Note: in the with-experts scenario, the number and period of corrections correspond respectively to the opinions of FDA officers and external experts; for Tier 1 with experts, the period listed in the official diagram is 5 working days.
In addition, in the official diagram the number of Major changes is 4-5 for Tier 4 and 5 or more for Tier 5, which leaves an overlap at 5 Major changes. When making an actual submission, it is advisable to confirm this threshold number with the Thai FDA.
5. Official Fee Schedule for Medical Device Changes
The Thai FDA lists the corresponding change fees according to the product submission type and whether external expert evaluation is required.
All amounts below are in Thai Baht (THB).
| Application type | Application fee | Expert technical document evaluation fee | Total |
|---|---|---|---|
| Domestic manufacturing: Detailed Notification | 500 | 19,200 | 19,700 |
| Import: Detailed Notification | 500 | 24,000 | 24,500 |
| Domestic manufacturing: License | 500 | 24,000 | 24,500 |
| Import: License | 500 | 30,000 | 30,500 |
Fee notes:
- The application fee is 500 THB.
- When external expert evaluation is required, the expert technical document evaluation fee is paid according to the corresponding application type.
- If external expert evaluation is not required, only the 500 THB application fee is charged.
Therefore, when budgeting for a change, companies first need to determine whether the product falls under Detailed Notification or License, and then confirm whether expert evaluation is required.
6. Preparing Change Application Documents
For Class 2-4 medical devices, a change application requires the corresponding supporting documents to be prepared according to the specific change items.
Based on the change document list published by the Thai FDA, the following documents may be involved:
| Document category | Main documents |
|---|---|
| Basic product information | Device Description |
| Labels and instructions for use | Device Labelling, updated IFU |
| Conformity documents | Updated Declaration of Conformity |
| Authorization documents | Letter of Authorization (applicable to imported products) |
| Product comparison documents | Comparison table of Design, Specification, and Intended Use / Indication |
| Safety documents | Adverse Event (AE), FSCA |
| Manufacturing documents | Manufacturing Information |
| International registration documents | Marketing History |
| Verification documents | Summary Verification & Validation |
| Quality system | ISO 13485 or GMP certificate |
| Other technical documents | Clinical Evidence, Cybersecurity, Risk Analysis, etc. (where applicable) |
| Change supporting documents | Rationale for the change, evidence of change approvals in other countries, etc. |
It should be noted that not every change requires all of the above documents. Companies should prepare documents according to the change item, the original registration documents, and the corresponding FDA document list.
7. What Should Companies Focus on When Handling Changes?
1. Assess the registration impact before changing the product
When adding product models, specifications, or accessories, or adjusting the design or software, first determine whether a change application must be submitted to the Thai FDA, and the corresponding change classification.
2. Prepare reference country approval documents in advance
If the relevant change has already been approved in a reference country, prepare the corresponding approval evidence and assess whether it meets the conditions for the reference country approval route.
3. Plan multiple changes in advance
When a single product involves multiple changes, the numbers of Major and Minor changes must be counted and the review tier assessed according to the official conversion rules, to avoid underestimating the submission timeline.
4. Allow time for technical review and corrections
For items requiring external expert evaluation, the review timeline increases accordingly. Companies should prepare technical comparison documents, risk analyses, and verification documents in advance to reduce the impact of corrections on the project schedule.
5. Calculate change fees in advance
The expert evaluation fees differ across registration types. The expert evaluation fee is highest for imported License products at 30,000 THB, or 30,500 THB in total together with the application fee.
8. Summary of Key Points of This Update
| Item | Main requirement |
|---|---|
| Class 1 changes | Submitted via Skynet, approved automatically by the system |
| Class 2-4 changes | Handled according to the change application procedure |
| Change classification | AUTO APPROVE, MAJOR CHANGE, MINOR CHANGE |
| Reference country approval | Changes already approved abroad follow a separate review timeline |
| Review timeline | 15-85 working days for changes not approved by a reference country |
| Change count conversion | 3 Minor changes are converted into 1 Major change |
| Correction requirements | Number and period of corrections determined by the review tier |
| Official fees | Application fee of 500 THB; expert evaluation fee depends on the registration type |
The above are the key points of this Thai FDA change management update. Before handling a change, companies are advised to confirm the applicable route according to the registration type, then check the reference country approval status and the number of changes, and plan document preparation and timeline expectations accordingly; when multiple changes are involved, combined planning is recommended to reduce duplicated reviews.