Regulatory ESSENTIAL



Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

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Scope: This ESSENTIAL describes the regulatory requirements of medical devices in South Korea, based on the - Medical Devices Act and its enforcement regulations - Additional information from Korean MFDS webpages Health products are classified into four risk classes, according to the risk associated with their use: Class I - very low Class II - low Class III - moderate Class IV - high Not in scope of this CRF: - In-Vitro Diagnostics (see: ESSENTIAL KOR In-Vitro Diagnostics)

Stakeholders: Manufacturer, Importer
Legislation in force: SECTION 2 Import Business Article 15 (Import Business Permission, etc.) (1) A person who intends to engage in the business of importing medical devices shall obtain import business permission from the Minister of Food and Drug Safety. (2) A person granted import business permission under paragraph (1) (hereinafter referred to as "importer") shall obtain import permission or import certification, or file an import notification with regard to medical devices that he/she intends to import, according to the following classifications: 1. For medical devices designated and publicly notified by the Minister of Food and Drug Safety and unlikely to pose any risk to human safety and health even upon occurrence of a failure or malfunction because of marginal potential risk to human health: Import permission, import certification , or import notification, by item category; 2. For any medical device other than those falling under subparagraph 1: Import permission, import certification, or import notification, by item. (6) The provisons to Article 6 (1), Article 6 (5), (7) through (10), Articles 6-2, 6-3, 7 through 9, 11 through 13, 13-2, and 14 shall apply mutatis mutandis to medical devices imported pursuant to paragraphs (1) through (5) and the importers of such medical devices. In such cases, the term "manufacturing" shall be construed as "import;" "manufacturing business permission" as "import business permission;" "manufacturing permission" as "import permission;" "manufacturing certification" as "import certification;" "manufacturing notification" as "import notification;" "production management" as "import management;" and "manufacturer" as "importer," respectively. The Enforcement Rule details the regulation of the Medical Devices Act: - Application for Manufacturing Business Permission - Procedures of Manufacturing Permission, Manufacturing Certification, or Manufacturing Notification - Application for Import Business Permission - Application for Import Permission - Exemption from Permission for Medical Device Import Business - Notification of Repair Business - Management of Medical Devices Subject to Tracking Management - Procedures for Recall of Harmful Medical Devices Regulates the work of the Korean Medical Devices Committee. Regulations on medical device licensing, notification, examination, etc. - Content: Chapter 1 - General (Purpose, Definitions etc.) Chapter 2 - Medical Device Items and Items Authorization Certification Notification Chapter 3 - Medical Device Authorization Certification Application and Declaration Item Details, etc. Chapter 4 - Examination of technical documents, etc. Chapter 5 - deleted Chapter 6 - Designation of Rare Medical Devices, etc. Chapter 7 - deleted Chapter 8 - Step-by-Step Audit Operation Chapter 9 - Designation of medical devices exempt from sales business notification Chapter 10 - Approval of Medical Devices for Exhibition Purposes Chapter 11 - Allowable range for improving the performance of medical devices Chapter 12 - Review of Medical Device Eligibility Chapter 13 - Supplementary Provisions

Application national: Korea, Medical Devices, MFDS authority, Notification/Certification/Approval Process

Countries: Image for KR Korea, Republic of (South Korea),  
Status: Published 2023-04-20 by Anette Dunkel-Reinboth and Benjamin Kerger
Last change 2024-04-10 by Ina May: Legislation in force for this PCT, Medical devices
ROGER WILLCO ID: #wo6i
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Scope of this ESSENTIAL
This ESSENTIAL describes the regulatory requirements of medical devices in South Korea, based on the
- Medical Devices Act and its enforcement regulations
- Additional information from Korean MFDS webpages

Health products are classified into four risk classes, according to the risk associated with their use:
Class I - very low
Class II - low
Class III - moderate
Class IV - high

Not in scope of this CRF:
- In-Vitro Diagnostics (see: ESSENTIAL KOR In-Vitro Diagnostics)'

Analysis of regulatory requirements

Legislation in force for this PCT
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Responsible actors
Here you will get textual information

Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
Here you will get textual information

What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses
Here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
Here you will get textual information

E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
Here you will get a image or chart

Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Route to compliance

Formal and administrative requirements

Registration at related authority required?
Here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
Here you will get textual information

[Yes/No]

IMDRF Membership
Here you will get textual information

Established in October 2011, the IMDRF is a forum for medical device regulators from multiple jurisdictions who have agreed to work together to promote international harmonization and convergence in the medical device field. The IMDRF builds on the foundational work of the Global Harmonization Task Force (GHTF), which was established in 1992 with the EU as one of the founding members.

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
Here you will get a image or chart

Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)
Here you will get textual information

Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority
Here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
Here you will get textual information

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
Here you will get textual information

e .g. formal application

Is a factory inspection legally required
Here you will get textual information

Testing & Standards

Specific requirements for testing
Here you will get related hyperlink(s)

e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Is in-country testing legally required?
Here you will get textual information

Acceptance of foreign test reports
Here you will get textual information

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get a image or chart

e. g. product label

Regulatory e-labelling allowed?
Here you will get textual information

e. g. put the regulatory information and labels in a software menu

UDI marking
Here you will get textual information

Required information on the product and/or packaging
Here you will get textual information

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
Here you will get textual information

Regulated by the legal provisions

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes


Code, ContinentKOR,
Economic Area
Official LanguageKorean - Framework Act on Korean Language | https://www.law.go.kr/LSW//lsInfoP.do?lsiSeq=211473&chrClsCd=010203&urlMode=engLsInfoR&viewCls=engLsInfoR#0000
Standard InstituteKorean Agency for Technology and Standards | https://www.kats.go.kr/main.do
HS CodememberYes | https://www.wcoomd.org/en/topics/nomenclature/overview/list-of-contracting-parties-to-the-hs-convention-and-countries-using-the-hs.aspx






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