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Regulatory ESSENTIAL
Korea, Republi. - In-Vitro Diagnostics

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

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Stakeholders:      Manufacturer, Importer     
Application: Korea, In-Vitro Diagnostic devices, MFDS authority, Notification/Certification/Approval Process
Countries: Image for KR Korea, Republic of (South Korea),  
#mo6x  
Status: Published 2023-04-20 by Anette Dunkel-Reinboth and Benjamin Kerger
Last change 2023-12-13 by Anette Dunkel-Reinboth: Link/Reference to other reference document(s), In Vitro Diagnostic (IVD)
   
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Subject Areas of this Essential:


In Vitro Diagnostic (IVD)

Scope of this ESSENTIAL
This ESSENTIAL describes the regulatory requirements of In-Vitro Diagnostics medical devices in South Korea, based on the
- Act on In-Vitro Diagnostic Medical Devices and its enforcement regulations
- Additional information from Korean MFDS webpages

In-Vitro Diagnostics 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
The classification is harmonized with the IMDRF rules.

Not in scope of this CRF:
- Medial Devices (see: ESSENTIAL KOR Medical Devices)'

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 licence)

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 licence)

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 licence)

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 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

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 licence)

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

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

User instruction requirements and specific compliance notes
here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

General Information:

   Korea, Republic of (South Korea)

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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