In cases where identity verification cannot be completed via the Thai ID application as required by the system, the authorizer or the authorized person may instead use the document-based identity verification method.
Power of Attorney (POA) to the Thai FDA is to formally authorize a representative, often a local agent or authorized person, to act on behalf of a manufacturer, importer, or distributor in regulatory matters. This ensures that the FDA can verify identity, hold someone legally accountable, and streamline communication during medical device registration and licensing.
Read the full announcement here:https://medical.fda.moph.go.th/open-system-license/system-license-online/
Purpose of the Announcement
To provide an alternative document-based identity verification method where identity verification cannot be completed via the Thai ID application as required by the system.
To clarify the submission process for Power of Attorney (POA) in relation to regulatory matters handled through the Thai FDA system.
Scope of Application
This procedure applies to those who intend to use the Skynet system of the Medical Device Control Division.
It is relevant to manufacturers, importers, distributors, authorizers, authorized persons, local agents, and representatives involved in medical device registration and licensing matters in Thailand.
Procedure
The document-based identity verification process involves the following steps:
- Submit the application in the system.
- Receive the tracking number.
- Send the “Document Submission Form for Power of Attorney Management System” file to the email: esubmdcd@gmail.com.
- The FDA officer will review the documents to help reduce errors and facilitate the submission of the original documents.
- Once the review is complete, the original documents can be submitted to the Medical Device Control Division.
Implications to Clients
This procedure applies to those who intend to use the Skynet system of the Medical Device Control Division.
Clients who are unable to complete identity verification via the Thai ID application should prepare the required Power of Attorney documentation and follow the document-based verification process.
Proper submission of POA documents helps support identity verification, legal accountability, and smoother communication with Thai FDA during medical device registration and licensing.
Effective Date
Immediately
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.