Medical Device Authorization in Korea: Five Things to Define Before Searching for a Product Category

Reasons It Is Difficult to Determine Pathways Based on Similar Names Alone

When preparing for approval, the first step is often to find item names and classifications of similar products.

The search results are just a starting point; simply finding products with similar appearances or names does not determine the application pathway.

The MFDS approval procedure guidance includes not only targets for Class 3 and Class 4 approvals but also cases where Classes 1 and 2 are eligible for approval.

One should not conclude the approval, certification, or reporting pathway based solely on a single grade number.

MFDS Medical Device Approval Procedures

The five items below are MedQraft's product description structure for initial review rather than a legal submission format.

Five Aspects to Include in a One-Page Product Description

Item	Content to Organize	Expressions to Avoid
Intended Use	What is being measured, diagnosed, treated, or assisted?	‘A device that helps health’
Mechanism of Action	What inputs and operations lead to results?	Listing only key component names
Product Composition	Differences in hardware, accessories, consumables, software, and models	Describing prototypes that differ from market composition
Conditions of Use	User, subjects, location, and method	‘Anyone can use it anywhere’
Comparison Target and Differences	Differences in purpose, principle, materials, and performance	‘Almost identical to existing products’

Unconfirmed information should be marked as 'under review'.

Particularly, the current range of products and future development scope should be separated to reduce the frequency of changing review targets.

The Description of Reviewed Products Differs Even with the Same Sensor

For instance, one hypothetical sensor product displays measurement values, while another interprets values to provide judgments concerning specific conditions.

This difference cannot be sufficiently explained by simply stating 'additional screen functionality'.

It is essential to explain who receives what information and how the user makes decisions based on it.

This example does not relate to determining specific ratings or whether a product qualifies as a medical device.

It is recommended that developers and regulatory affairs personnel review the same product together, placing the intended use statement next to the functionality list and results screens for collective examination.

Include Grounds for Judgment in Comparison Tables

When comparing with existing products, do not merely fill in identical and different columns, but also document what materials were checked.

Do not simply mark as 'identical' if the raw materials or test conditions are unknown.

Dividing each comparison item into verified information, remaining differences, and additional verification needs will illuminate unresolved issues.

Identifying what needs confirmation first can reduce commencing tests or documentation work without direction.

Create Submission Material Lists After Product Description

Using the test list of another product directly may result in omitted necessary assessments, or tests may be commissioned without reviewing their applicability.

Below is a list of questions to evaluate necessity rather than a final submission obligation list.

Product Characteristics	Review Questions	Initial Verification Materials
Human Contact	Which parts are contacted, in what way, and how much?	Contact material, structure, and usage conditions
Electrical Use	What are the power and usage environment, and what devices are connected?	Electrical schematic, usage environment, accessories list
Sterilization Supply	How is the condition maintained through processing and packaging?	Sterilization and packaging specifications and available evaluation materials
Software	What inputs are processed, and how are results utilized?	Function specification, version, result screen
Performance Claims	What can be explained under which conditions?	Specifications, test methods, available results

Each item in the table is a starting point for review.

This does not mean that the same tests are required for all products or that a single report can substitute for documentation.

The actual submission range and the applicability of exemptions must be confirmed based on applied regulations and individual product justifications.

Connect Initial Review Outcomes Back to Development Changes

Consider a hypothetical product where the material of a disposable accessory was changed during the review process.

Merely altering the drawings can cause discrepancies between the product description and the test materials.

Reflect any changes in the product description and reassess the impact on existing comparison and evaluation plans.

Internal review records should document what part changed from what to what, which models and timings apply, and what data validates the effects instead of just noting 'material change'.

If it is a previously approved product, it is also necessary to review whether the change procedures apply separately.

Summarize the Initial Review Results in Three Bundles

1. Confirmed Items: Product composition and intended use, confirmed regulatory and item information, and sources.
2. Unresolved Items: Questions needing additional materials or confirmations with relevant authorities, as well as assigned personnel.
3. Follow-up Work: Determined tasks such as data research, evaluation planning, and technical document organization, along with prerequisites.

By organizing in this manner, one can transform the expression 'preparing for approval' into actionable tasks.

Even though the first review does not guarantee ratings, total costs, or timeline, subsequent steps can be concretely decided.

Materials to Prepare Before Consulting

Initially, a product description, composition diagram, operation video or screenshots, comparison target information, and a test materials list will be useful.

Additionally, include version numbers and date of creation.

The aim is to prevent mixing product descriptions from different points in time.

Later, review applicable regulations, item classifications, grades, application pathways, technical documents, and quality management tasks.

It is also necessary to check separate application systems for digital medical devices and in vitro diagnostic medical devices.

MedQraft currently confirms the state of product definitions and documents to negotiate the additional scope of approval and quality tasks.

Actual submission decisions must be based on current laws, announcements, and product characteristics.