KC for Electronic Products

We support world leading manufacturers in the rapid certification of electronic products for the Korean market.

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KC-EMC Certification

We clarify the requirements for your product and ensure that your product is certified quickly and reliably.

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KCs - Korea Certification Mark for machines

Korea Certification is an excellent partner for KCs certification for machines. We ensure that you get your product approved quickly and reliably.

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KEMCO Certification

Korea Certification ist der ideale, strategische Partner für die KEMCO Zertifizierung. Wir unterstützen Sie bei allen Schritten zum koreanischen Energieeffizienz-Label.

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Training

Korea Certification offers customized certification training to fit your company needs. Our trainer will come to your location and provide the training, up to date information and pass on valuable tips from our many years of experience. Call us today to learn more!

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MPR International

Since 2005, MPR International GmbH has been supporting companies around the world in obtaining the required product certifications for the Asian markets. With a strong team located worldwide, we can offer you the best solution for your enquiries.

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MFDS certification

1. What is the MFDS certification

The MFDS certification was established for the large proportion of imported medical devices that are produced by foreign manufacturers and used in Korea. In some segments, foreign manufacturers have a share of over 50% of medical devices. An aging population and rising per capita incomes make South Korea a very attractive market for medical device manufacturers.

The main authority for all medical approvals and certifications is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration (KFDA).

Before entering the Korean market and selling products like medical devices, foreign manufacturers must register with and obtain approval from the MFDS.

Preliminary regulations from 1997 have evolved into the Medical Device Act of 2004 that defines the basic regulatory framework for the registration of medical devices in South Korea.

 

Local representative

For almost all the medical certifications, a foreign company must appoint a local representative or In-Country Caretaker (ICC), which has to be a Korean entity. This entity will be the applicant and holder of the product registration and bears numerous responsibilities.

Foreign companies that do not want to use their importer or distributor as their local agent can either have a local Korean office or appoint an independent entity or local agent to take over this responsibility, while maintaining flexibility by not being tied to a certain distributor, that holds your registrations.

Responsibilities of the appointed entity include applying to the MFDS for approval, ensuring correct Korean labeling, documentation and reporting of issues or product failures and submission of insurance reimbursement applications. This entity can also act as the go-between of the foreign manufacturer and their distributors.

 

Cosmetics

Regarding the MFDS certification, Cosmetics can be categorized into two different categories: general cosmetics and functional cosmetics.

General cosmetics can be manufactured and imported into Korea without prior registration by importers or manufacturers that are already registered with the MFDS. This registration makes them subject to post-market supervision.

For functional cosmetics, manufacturers or importers have to go through prior evaluation by the MFDS and cannot be marketed in Korea beforehand.

 

2. Medical devices

In general, medical devices require a registration with MFDS before they can be sold in the Korean market. Approval is normally granted by the Medical Device Information & Technology Centre (MDITAC), which is subordinated to the Ministry.

Medical devices can be classified into three main types:

  • New product: this is a device that has no equivalent to an already approved medical device in terms of usage, working mechanism or materials
  • Improved product: a device that has an equivalent to an already approved device in terms of usage, working mechanism or materials, but is different in performance, specifications or ease of use
  • Equivalent product: this is a medical device that is equivalent to an already approved device in all aspects such as usage, working mechanism, materials or performance

Another crucial aspect for the medical device registration is the classification into the correct class. The MFDS specifies four different classes:

  • Class I: Medical device with low risk
  • Class II: Medical device with medium risk
  • Class III: Medical device with medium-high risk
  • Class IV: Medical device with high risk

 

Registration Process

Depending on the classification there are different approval processes:

  • A Class I medical device only needs to provide pre-market notification to the authority. The application documents have to contain the required medical device information and have to be in Korean.
  • Class II, III and IV medical devices must be classified into one of the aforementioned types. Application documents and clinical data must be submitted and has to go through a technical documents review. Local tests are usually required.
    • Foreign manufacturers must comply with Korea Good Manufacturing Practice (KGMP), which includes an on-site audit, prior to the device registration

In general, approval in the country of origin is not required for the MFDS certification.

 

KGMP certification

Medical devices of class II and above are required to comply with KGMP standards. These are based on ISO 13485, but are not completely identical to these quality standards. Therefore, ISO 13485 certificates issued by bodies outside Korea, for example the EU, are not sufficient and require a separate KGMP certification.

To obtain the certification, different documents for aspects such as risk assessments, design and technical requirements must be prepared and submitted. After a review, the production facility has to go through an on-site inspection by MFDS or an authorized third party.

A KGMP certificate is valid for three years and must be obtained before the medical device registration process with the MFDS as it is an essential requirement for gaining product approval.

 

Further Information:

If you need assistance or have any questions, feel free to contact us any time.

Tel.: +49-69-2713769259
Email: info@korea-certification.com

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