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Technical File & Registration

Your Gap Analysis is Complete. Now Get the Approval.

Submission is where most foreign manufacturers lose 12 months they cannot recover.

Korean Technical File Authoring

Korean Technical File Authoring

Reconstructed from your existing data to MFDS structural and content standards. Not a translation — a Korea-native regulatory document built from the ground up.

MFDS Submission Management

MFDS Submission Management

Full preparation, packaging, and official submission through the MFDS portal, including all intake confirmation and logistics.

Deficiency Letter Defense

Deficiency Letter Defense

Citation-backed, logically structured responses to every MFDS reviewer query — protecting your review timeline and eliminating the risk of forced resubmission.

Service specification

The Product License

Korea Technical File & Registration

You receive a fully issued MFDS product license. Every milestone is billable only upon completion.

Request assessment

MFDS expertise — not translation — wins Korean approval. Without a Korea-side team, deficiency responses get exhausted and the project resets, adding 9–12 months.

Complete Korean Technical File, authored in Korean to current MFDS requirements.

Official MFDS submission package with all required forms, declarations, and attachments.

Written deficiency response letters for every reviewer query received during the review period.

Final MFDS product license, delivered upon official issuance.

Frequently Asked Questions

Common questions about the Korean Technical File registration process.