On July 22, 2025, the Thai Food and Drug Administration (Thai FDA) introduced updated prescribed forms for the renewal of medical device notifications and licenses, replacing the previous versions outlined in the 2021 announcements. This update is issued under Section 12 of the relevant Ministerial Regulations and ensures that the forms align more closely with regulatory requirements.
The updated forms apply to:
- Class 2 and 3 medical devices (notifications)
- Class 4 medical devices (licenses to manufacture/import)
Key Changes
- Discontinuation of Older Forms: The previous forms for renewal are now repealed, including:
- Notification to manufacture (Form จ.ผ. 2 / Jor.Por. 2)
- Notification to import (Form จ.น. 2 / Jor.Nor. 2)
- License to manufacture (Form ผ.พ. 2 / Por.Por. 2)
- License to import (Form น.พ. 2 / Nor.Por. 2)
- Introduction of New Forms: The following updated forms must now be used for renewals:
- Form จ.ผ. 2-1 (Jor.Por. 2-1)
- Form จ.น. 2-1 (Jor.Nor. 2-1)
- Form ผ.พ. 2-1 (Por.Por. 2-1)
- Form น.พ. 2-1 (Nor.Por. 2-1)
This update was signed by Surachoke Tangwiwat, Secretary-General of the Thai FDA.
Effective Date: July 22, 2025
Implications for Clients
Importers and local manufacturers who are submitting renewal applications for either notifications (Class 2 and 3) or licenses (Class 4) must now use the newly prescribed forms, which are effective immediately.
Should you have any inquiries regarding the announcement, please don’t hesitate to reach out to us. You can contact our team at sales@andamanmed.com or simply click on the button provided below.
