Comparing Current Approval Requirements Before Product Changes

A small change does not define the review scope

At a development meeting, someone proposes a slight change to the appearance.
The person responsible wants to know whether revising the drawings is enough or whether regulatory review is also needed.
However, the word “slight” does not adequately identify what differs from the existing state.

First, establish the baseline for the change.
Check whether the current approval, certification or notification details, the specifications used internally, and the proposed change for the next production run are connected on the same basis.
Finding the latest drawing alone does not automatically align these three.

This article is for practitioners preparing to review changes to domestically manufactured medical devices in Korea.
It does not explain initial product classification or determine whether an individual change requires authorization.
Imported devices, digital medical devices, and in vitro diagnostic devices require review of their respective legislation and separate requirements.
The comparison tables, hypothetical case, and review sequence below are MedQraft’s own practical suggestions.

Place Current Approval Details and Change Proposals Side by Side

Article 26, Section 3 of the Medical Device Act enforcement rules stipulates materials for verifying changes in the approval, certification, and reporting items of manufacturing items.

It also differentiates materials regarding significant changes that may affect safety and effectiveness.

Here, we focus on organizing the facts necessary to start evaluating the specified clause.

National Law Information Center Article 26

We compare the existing details with the proposed specifications based on the same model.

The person in charge should first collect existing approval, certification, and reporting materials and the history of any changes that have been reflected so far.

Next, they should specify the models, parts, or configurations to be changed.

To avoid mixing materials from similarly named models, it is essential to also specify the model name and document version.

If there are already unexplained differences between internal specifications and approval details, they should not be included in this change proposal.

It is necessary to distinguish existing differences from newly proposed changes so that reviewers can verify the occurrence and basis for each.

The aim is to avoid a situation where a new specification is approved while the starting point for comparison remains unclear.

The Name of the Change and the Processing Method Are Different Pieces of Information

Section 5 of Article 26 assumes minor changes correspond to items announced by the Minister of Food and Drug Safety.

Section 8 mandates that details on criteria, procedures, and documentation requirements be announced.

Thus, terms like "appearance" or "minor changes" do not conclusively determine the processing method.

Article 26, Sections 5 and 8

Consider separating the practical memo into two columns.

One column is for what changes are being made and the next for which criteria they correspond to.

In the judgment column, leave the applied criteria and review basis.

If documentation is insufficient, record unverified items and the person responsible for verifying them instead of a temporary conclusion.

This discussion does not confirm the detailed list of minor changes, submission timing, or exemption scopes for submitted materials.

It is important to verify the application items of the current announcements relating to the specific products and changes in question.

It is better not to rely on generalized summaries of the internet as the final basis for judgment when a step-by-step evaluation of procedures is necessary for each product.

The Comparison Table Should Also Note Reasons for Similar Items

The comparison table can be structured somewhat broadly to include items that differ.

It is useful to briefly document which materials were verified to conclude that certain items remain unchanged.

Conversely, if there is no evidence, denote it as ‘unverified’ instead of ‘same.’

Comparison Item	Things to Contrast Between Existing Standards and Changes	Supporting Material
Model/Configuration	The model and parts applicable under this change	Model list, configuration diagrams, and revision numbers
Materials/Specifications	The actual differences in materials, configuration and specifications	Material standards and specific portions of drawings
Usage Conditions	Purpose, contact sites, and usage methods	Relevant approval details and usage instructions
Performance/Evaluation	Characteristics claimed to remain unchanged and differences	Material relating to samples and conditions explained
Follow-up Actions	Questions yet to be answered	Person responsible and necessary materials with timing

The table is not a legal submission format but is a self-assembled structure for review.

This does not imply that every item requires new testing.

First, review how far the existing evidence explains the proposed changes, and use it to clarify areas needing additional evidence.

Providing not just the title of one document but also connecting it to the specific page or item makes verification easier.

Records that clarify what specifications the samples evaluated under what conditions provide valuable information for the next judgment.

Hypothetical Case: Reviewing a Change in Outer Casing Color

Hypothetical Scenario:

A proposal has come in to change the outer casing color of a device.

In the meeting, it was explained that only the color differs, but the specifications and application model range of the new dye have not yet been communicated.

At this stage, rather than finalize the change process, we outline necessary facts.

We distinguish between visible differences in appearance and differences in material and configuration for verification.

The first question concerns material information.

We should check whether the base resin remains the same, whether the dye or other components vary, and if we can confirm precise specifications.

Next, we verify the usage conditions.

We need to ascertain where it will be used, how the contact conditions and handling methods are maintained.

Finally, we should assess the scope of existing materials.

If existing specification materials claim to explain what is affected by the change, we need to document what basis supports this judgment.

Currently Confirmed Facts	Areas Not Yet Verified	Materials for Next Review
The change in outer casing color has been proposed	Differences in dye and material composition	Materials specifications before and after change
Plans to prioritize applying to certain models	Common use with other models and parts	List of applicable models and parts
Existing evaluation data is stored	The relationship between evaluation samples and new specifications	Sample information and related evaluation basis

Here, we are not assessing specific approval procedures or testing necessities.

We are preparing a summary of unverified items so that the reviewer can view the tangible differences and bases before making a judgment.

Changing colors does not always entail following the same procedures, nor does it mean that verifying these three items is sufficient as a generalization.

Connecting Comparison Results to Judgment and Action Plans

Once the list of differences is created, the regulatory personnel can review the applicable criteria.

The guidance provided by the Food and Drug Safety Agency also presents change approvals as an independent task.

However, general procedural outlines alone cannot confirm the pathways or submitted materials for individual products.

Food and Drug Safety Agency Medical Device Approval Procedure Guide

For each item compared, connect established bases and remaining reviews.

In practice, consider the tasks of receiving judgments and integrating those judgments on-site into your planning.

For example, coordinating with relevant persons regarding when to apply the new specifications, whether differentiation from existing materials is necessary, and how to align related manuals and model information.

These items are operational questions that can be tailored to individual situations.

The important point is not to make unresolved states appear to be completed.

Expressions like ‘request for review’, ‘securing additional materials’, ‘confirmation of pathway’, and ‘preparation for execution’ should clearly reflect actual status, revealing what remains during scheduling meetings.

The review is not concluded by merely indicating submission or internal approval alone.

Five Questions to Confirm in Change Meetings

1. Have the target model and current approval, certification, and reporting details for this change been accurately confirmed?
2. Were the specifications before and after the change compared based on the same items and version criteria?
3. Is there supporting evidence even for areas marked as ‘same’?
4. Have the determinations based on applicable criteria been distinguished from simple change explanations?
5. Are there unverified items, future responsible persons, and tasks to confirm before execution still remaining?

Related Article: Domestic Medical Device Approval, Five Things to Organize Before Item Name Search.

If you are at the initial stage of defining a product, start with existing documents, and if at the stage of comparing previously received details with change proposals, start with the questions in this article.

Reference Materials and Application Scope

• National Law Information Center, Article 26 of the Medical Device Act Enforcement Rules.

The verified provision has been in effect since July 1, 2026, as part of the amended Prime Minister’s Decree No. 2127.

Reference was primarily made to Sections 3, 5, and 8 regarding changes to domestically manufactured items.

Original Text of the Provision

• Food and Drug Safety Agency Medical Device Electronic Civil Service System, Approval Procedures.

General work guidance has been referenced.

It has not been determined in this text how the latest announcements apply to individual products, nor their timing of submission exemptions or handling.

Official Guidance

Verification Date: September 27, 2026.

The scope of the law and the proposed practical application have been distinguished.

The case studies, tables, and illustrations in the text were directly organized by MedQraft and did not utilize actual customer cases or approval results.

Specific applications of the law should be verified separately based on the product and change details.