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GLGlossary

Regulatory glossary.

Plain-language definitions of the terms that come up in Korean medical device regulatory work.

General information · confirm your specific case in consultation

GL-01Terms

01

Regulatory approval

The process of proving to the regulator that a device is safe and its performance is verified, and obtaining permission, before it can be sold.

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02

Classification (device class)

A grouping of medical devices by risk level. The higher the class, the deeper the verification process.

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03

Technical documentation

A set of documents showing that a product was designed and manufactured to standard.

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04

KGMP (manufacturing and quality management standard)

A standard for verifying a manufacturing site's quality management system so that medical devices are made to a consistent quality.

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05

Test report

A document containing the results of testing that confirms whether a product meets the specified standards and criteria.

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06

Clinical evaluation

The process of compiling and evaluating materials that clinically support a product's safety and performance.

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07

Import and manufacturing business

The business qualifications required to import or manufacture medical devices for sale.

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08

Post-market management

The quality and safety management and regulatory reporting work that continues even after approval or certification is obtained.

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09

Certification body / review body

An organization designated to review technical documentation or quality systems on behalf of the MFDS.

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10

Labeling and advertising

The rules that apply to the information written on a product's container, packaging, and instructions, and to the advertising that promotes the product.

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11

ISO 13485

The international standard setting out the quality management system a medical device company is expected to have in place.

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12

Manufacturer and manufacturing site

The company that actually makes the device (the manufacturer) and the location where that production takes place (the manufacturing site).

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13

Identical, equivalent, and improved devices

A way of classifying your device according to how closely it resembles a device that has already been approved in South Korea.

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14

UDI (Unique Device Identification)

A unique identification code assigned to each medical device so that it can be traced through distribution.

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15

CB test report

An electrical and mechanical safety test report issued by an accredited testing laboratory under the IECEE CB Scheme.

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16

Validation

Documented evidence that a given process or method consistently produces the result it is intended to produce.

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17

Risk management

Identifying the hazards a device could present in use, reducing them, and assessing whether the remaining risk is acceptable.

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The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.

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