The Thai Food and Drug Administration (FDA), through the Medical Device Control Division, has developed a document supplementation system to facilitate the upgrading of submission types from Partial 1, Partial 2, or Abridged to Full Common Submission Dossier Template (CSDT). This system is accessible via the TFDA’s Skynet platform and aims to streamline the upgrading process for medical device registration.
The system will be effective starting June 1, 2025.
System Availability Notice
- The document supplementation system for upgrading to Full CSDT is available annually from February to September.
- The system will be closed from October to January each year to accommodate the license renewal and notification certificate period.
| Summary of additional documents that must be attached to upgrade to the Full CSDT | ||||
| No. | Document evidence according to ministerial regulations | Partial 1 | Partial 2 | Abridged |
| 1 | Executive Summary | ✔ | ||
| 2 | Essential Principle | ✔ | ✔ | |
| 3 | Design validation and verification | ✔ | ✔ | ✔ |
| 4 | Risk Management | ✔ | ✔ | ✔ |
| 5 | Destruction method, Termination, or Waste disposal document | ✔ | ✔ | ✔ |
| 6 | GMP or Quality system certificate (ISO 13485) | ✔ | ||
| 7 | Declaration Letter of intended use, indication, packaging, labelling and instruction for use | Explanatory Letter on Document Supplementation and Compliance with Full CSDT Requirements | ||
| 8 | Marketing History Declaration | |||
| 9 | Safety Declaration | |||
| 10 | Document evidence of regulatory approval or marketing clearance obtained | |||
Steps for Using the Document Supplementation System to Upgrade to Full CSD
- Request access rights to use the document supplementation system.
- Log in to the Document Supplementation System via the left-hand menu.
- Select the relevant registration certificate from the drop-down list (only non-Full CSDT certificates will display).
- The system displays the PDF certificate and previously submitted documents.
- Click the “Attach Additional Documents” button.
- The system generates a list of required additional documents based on your current submission type.
- Attach all required documents and click “Save”.
- The system displays the request with status “Pending Officer Review.
Post-submission statuses may include:
- Request for correction
- Forwarded for defect inspection
- Approved
- Application rejected
- Application returned by the system
Note:Corrections may only be made once. If rejected, a new application must be submitted.
Implications to Clients
This system is developed to assist medical device operators who have previously registered medical devices under the Partial 1, Partial 2, or Abridged categories and now wish to upgrade their submission type to Full CSDT.
For more information or assistance, contact us at sales@andamanmed.com or click the button below.
