On July 18, 2025, the Thai Food and Drug Administration (FDA) issued a press release clarifying the differences between the Document Addition System (Upgrade to Full CSDT) and the Renewal System within SkyNet, the regulatory platform for medical device registrations. This clarification is critical for stakeholders managing existing licenses or notification certificates.
To view the official announcement (in Thai), refer to: [กองควบคุมเครื่องมือแพทย์ | Thai FDA Official Website].
Purpose of the Two Systems
The Thai FDA highlighted the distinct purposes of the two systems:
- Document Addition System (Upgrade to Full CSDT)
- Designed for operators who previously registered their products with partial document exemptions (Partial 1, Partial 2, or Abridged).
- Allows voluntary upgrading of registrations to the Full Common Submission Dossier Template (CSDT) format.
- Does not extend the current registration validity.
- Renewal System
- Allows renewal of registrations that are nearing expiration.
- Extends registration validity for an additional five years.
- Applicable to all registration types (Partial, Abridged, or Full CSDT).
Key Differences Between the Systems
Feature | Document Addition System (Upgrade to Full CSDT) | Registration Renewal System |
---|---|---|
System Purpose | Allows modification of registrations that previously received document exemptions (Partial 1, Partial 2, Abridged) to upgrade to full format (Full CSDT). | Allows renewal of registrations nearing expiration for an additional 5 years. Applicable to all types (Partial 1, Partial 2, Abridged, or Full CSDT). |
Who Should Apply? | Applicants wish to change their registration status to Full CSDT (voluntary, no impact on renewal eligibility). | Applicants need to renew their registration (mandatory before expiration). |
When to Apply? | Anytime the applicant is ready (system open annually from 1 Feb – Sep). | Within 90 days before expiration (system open annually from 1 Oct – Feb). |
Fees? | No fee required. | Fees apply, as per official regulations. |
Registration Validity | Does not extend the current registration period. | Extends validity for 5 years from the original expiration date. |
Document Addition System (Upgrade to Full CSDT)
What is it?
A voluntary channel for operators with partially exempted documentation to upgrade to Full CSDT.
Why upgrade?
- To demonstrate compliance with full technical documentation.
- To meet certain client or partner requirements.
- To become eligible for the Thai Innovation List (for domestic manufacturers).
Key Points:
- Not a renewal — does not extend validity.
- No fees required.
- Voluntary — operators may choose whether to upgrade.
Renewal System
What is it?
A process to extend the validity of medical device registrations for an additional five years.
When to apply?
- Within 90 days before expiration.
- Example: If a registration expires on December 31, 2025, renewal applications can start from October 1, 2025.
Key Points:
- Mandatory for all registrations (Partial, Abridged, or Full CSDT).
- No Full CSDT upgrade required before renewal.
Summary
- To upgrade documentation to Full CSDT → Use the Document Addition System.
- To extend validity of an expiring registration → Use the Renewal System.
Implications to Clients
Stakeholders should carefully determine which system applies to their situation:
- Use the Document Addition System if you wish to upgrade exempted registrations to Full CSDT.
- Use the Renewal System if your license or notification certificate is close to expiration.
This ensures compliance and uninterrupted product distribution in Thailand.
Effectivity Date
The notification took effect on July 18, 2025.
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