Responding to MFDS Requests: Link Each Question to the Answer, Revision and Evidence

The goal is traceable resolution of each request, not a larger file count. Adding documents does not close a question if the response and revised documents disagree.

1. Preserve the original request and separate working questions

Confirm the application identifier, notice, notification date, submission instructions and actual deadline. Do not infer calculation or extension rules from general experience. Split compound requests into working questions while preserving the original numbering and wording.

A request to justify a performance criterion and method and provide evidence may involve the criterion, method, supporting material and dossier updates. Assign internal sub-identifiers, owners and evidence needs without narrowing or changing the original meaning.

2. Use one row per resolvable question

This is a practical example. Where a specific format applies, follow it while preserving traceability.

Explain what changed and why rather than writing completed. For a new report, identify how its test article relates to the application model. File delivery alone does not establish resolution.

3. Separate clarification from missing evidence

Where submitted information already answers the question, pinpoint its location and applicability. Where a necessary condition or model has not been tested or documented, a longer explanation cannot manufacture the missing evidence. Distinguish available, internally prepared and externally sourced material to expose dependencies.

Send the manufacturer the exact product, version and conditions needed as well as the request. Ensure translations preserve the technical question. Review received identifiers and scope rather than relying on a statement that the document is current. The technical documentation guide helps organize the dossier.

4. Propagate revisions to affected documents

Changes in performance, models, materials or use may affect applications, specifications, report explanations, labels and instructions. Identify shared values and update affected documents, rather than editing every file indiscriminately. An internal rationale for unaffected documents can be useful.

Narrowing or broadening intended use can alter clinical, performance and biological assumptions. Review application-scope handling, including new specifications received during supplementation. Consider the change registration guide while keeping the context of the pending application distinct.

5. Read the package in both directions

First trace every request into its response. Then trace each attachment back to the question it supports. Reassess unexplained files and find evidence named in the response but absent from the package.

Recheck page references after final PDF production; covers and contents can shift numbering. If marked and clean copies are required, verify that they represent the same revision. Match actual filenames to the response table and check required signatures or issuer information where applicable.

6. Distinguish submission from resolution

Retain receipt evidence, the actual file list and versions, and submission timing. Sending a package and receiving the authority's review are different states. Link subsequent questions to the existing history instead of overwriting the earlier response.

Track dependencies between manufacturer delivery, review, revision and final checks rather than only one target date. Explain timing from available evidence and remaining tasks without promising a fixed resolution or approval date.

Bring the request and original submission inventory to request a supplementation response review. Clare Partners can organize the connection between each answer, its evidence and revised documents.

Official references: Korean medical device review regulation · MFDS technical-document change review guidance announcement. Checked 2026-09-28. The table is a practical aid, not a statutory form. The actual notice and current submission procedures take priority.