On July 23, 2025, the Thai Food and Drug Administration (Thai FDA) announced a new system for the renewal of medical device licenses and notification certificates, to be submitted annually through the SKYNET online platform.
To view the official announcement and infographic, refer to:
กองควบคุมเครื่องมือแพทย์ (Medical Device Control Division)
Key Highlights
Annual Renewal Period
Medical device license and notification renewals must be submitted via the SKYNET system between October 1 and December 31 of each year.
Eligible Medical Device Groups
Renewal processes differ based on how the device was originally registered:
Group 1: Medical Devices Registered Under Full CSDT
- Manufacturers or importers may renew directly via the SKYNET system.
- No additional documentation is required for standard renewals.
- Licenses are automatically renewed upon payment.
- Exception: For HIV-related test kits, submission of a product analysis report is mandatory.
Group 2: Medical Devices Registered Under Partial 1 or Partial 2
- Additional supporting documents must be submitted.
- These will be reviewed with reference to Adverse Event Reports from the past 5 years.
Adverse Event Review Criteria
| Adverse Event Criteria | Case 1 | Case 2 |
|---|---|---|
| 1. Serious adverse events | No Serious Adverse Events occurred for all 3 criteria | No Serious Adverse Events occurred for all 3 criteria Occurred Serious Adverse Events one or the other criteria |
| 2. Medical device malfunctions that may lead to serious adverse events | ||
| 3. Incidents affecting the quality, efficiency, or safety of the medical device |
Summary of Required Documents for Renewal
| No. | Document Description | Case 1: No Serious Adverse Event | Case 2: Found Serious Adverse Events | ||||
|---|---|---|---|---|---|---|---|
| Full-CSDT | Partial 1 | Partial 2 | Full-CSDT | Partial 1 | Partial 2 | ||
| 1 | Executive summary | - | ✔ | - | - | ✔ | - |
| 2 | Essential Principles of Safety and Performance of Medical Devices | - | ✔ | ✔ | - | ✔ | ✔ |
| 3 | Summary of verification and validation | - | - | - | - | ✔ | ✔ |
| 4 | Risk analysis | - | - | - | - | ✔ | ✔ |
| 5 | Destruction method, disposal or waste management after use | - | - | - | - | ✔ | ✔ |
| 6 | Quality management system certificate | - | ✔ | - | - | ✔ | - |
| 7 | Declaration Letter of intended use, indication, packaging, labelling, and instruction for use | - | ✔ | ✔ | - | ✔ | ✔ |
| 8 | Marketing History Declaration | - | ✔ | ✔ | - | ✔ | ✔ |
| 9 | Manufacturer’s safety declaration | - | ✔ | ✔ | - | ✔ | ✔ |
| 10 | Approval evidence from foreign regulatory agencies (recognized by the Thai FDA) | - | ✔ | ✔ | - | ✔ | ✔ |
| Total documents required | 0 | 7 | 5 | 0 | 10 | 8 | |
Remark: Documents No.7-10 are Thai FDA templates, and they can be downloaded from the website of Medical Device Control DivisionRemark: Documents No.7-10 are Thai FDA templates, and they can be downloaded from the website of Medical Device Control Division
Implications to Clients
Importers and local manufacturers intending to renew medical device licenses or notification certificates must do so through the SKYNET system during the specified period each year.
Depending on the device registration type and history of adverse events, clients must ensure the accurate and timely submission of all required documents, including those tied to serious adverse event (SAE) assessments.
Effective Date
- Announcement Effective: July 23, 2025
- Renewal Period (via SKYNET): October 1 – December 31 (annually)
For further information or support, please contact us at sales@andamanmed.com or click the button below.
