Medical Device Regulatory Requirements for the Republic of Korea (South Korea)

Updated: 11/15/01

The U.S. Medical Device Industry held consultations in South Korea in April 2001 to discuss various medical device regulatory and reimbursement issues. Read the report.

Overview and General Requirements

Medical devices sold in Korea must obtain pre-market approval from the Korea Food & Drug Administration (KFDA). KFDA's Medical Devices & Radiation Health Department undertakes inspection and quality assurance for medical devices, sets radiation standards, manages radiation safety control programs, and conducts research on medical devices, radiation health and related areas. A medical device undergoes one of two different regulatory pathways, depending on its classification under the Korean regulatory system. KFDA requires pre-market notification for class I devices and pre-market approval for Class II and III devices. Since KFDA issues product licenses only to locally based firms, all foreign suppliers must submit required documentation and receive necessary approvals through their Korean distributors.

Medical devices must be approved for sale in their country-of-manufacture before they can be considered by KFDA for registration in Korea. To obtain registration of Class II or III devices, KFDA requires a documentary review of the technical file (registration dossier), as well as a local type test performed in Korea on samples imported with KFDA permission. KFDA will examine the submitted documents to verify the product's approval status in the country-of-manufacture, to review product certifications and manufacturers' testing methodology, and to review clinical trial data if required.

Legal Possession of Registration and the Role of Importers/Distributors

Korean regulations require that local distributors, not manufacturers, apply for and serve as the legal holders of medical device registrations for imported medical devices sold in Korea. To reduce complexity in distributor relations, many U.S. companies exporting medical devices to Korea rely on a single Korean distributor. However, there are two mechanisms by which exporters can rely upon multiple distributors in Korea.

A) The distributors hold separate approvals: In this case, each Korean distributor undergoes the full product registration procedure – at full cost – separately from one another. This approach can be costly for certain products. Therefore, in order to allow foreign manufacturers the opportunity to avoid redundant reviews and tests, regulations promulgated on September 22, 2000 allow the second or subsequently-retained distributors to obtain product registrations based on the registration held by the first distributor. To utilize this option, the second or later distributor must submit a copy of the registration documents submitted originally by the first distributor. Accordingly, the first distributor's cooperation is necessary in order to take advantage of this new regulation, and this can affect costs of that distribution arrangement.

B) A "principal" distributor or an independent consultant holds approval, and other distributors "share" the registration: In this case, when a distributor has registered a product, other firms can also import the same product based on this approval. However, these other firms must receive a documented concession from the registering company. This arrangement is usually possible when distributors are not in a competing relationship. Alternatively, an independent consultant, retained by the manufacturer, holds a product approval, and all distributors have equal access to it in order to import the product. In this last case, provided it can identify local distributors who are willing to carry the product without holding the registration, a non-Korean manufacturer can have more direct control over the product license through its retained local consultant, and doesn't risk facing the need to obtain new approvals in case it wishes to change distributors.

Note: Korean regulations require medical device importers to maintain qualification certifications from a KFDA-authorized entity that can issue such licenses. These licenses, called "Certifications of Compliance to Quality Management System (QMS) for Imported Devices," are approved on a category basis. For example, once a Korean importer has received a quality system certification for orthopedic products, it is licensed to import any orthopedic product from any manufacturer. All devices are divided into 39 categories for purposes of these certifications, and certification to each category involves company site audits by an inspection entity every two years. In concept, the QMS certification criteria are based on ISO standards. Among the major requirements for device importers are quality system documentation, warehouse facilities, and the necessary equipment for after-sales service.

Device Classifications

The first step in obtaining marketing clearance is to make sure that the device you intend to export to Korea is classified as a medical device under the Korean classification system. A list of all the regulated devices in Korea is available in "Regulations Regarding Designation of Medical Devices" (KFDA Notification 2000-37, August 1, 2000). As in the U.S. Food & Drug Administration (USFDA) system, Korean Class III indicates products of highest potential risk. Thus, approvals for these products require more extensive information on product safety and efficacy than products in classes I or II.

Generally, U.S. and Korean classifications are consistent for most products. However, some products which are not considered as medical devices in the U.S. are medical devices in Korea and vice versa. For example, magnetic bed mattresses, skin care/esthetic equipment, high-pressure water jet bathtubs and some laboratory testing equipment are all considered as medical devices in Korea but not in the U.S. If your product is not listed in the Korean classification system, but, based on U.S. regulations you believe that your product is likely to be considered a medical device in Korea, consult with your Korean importer, who can request that KFDA determine whether your product is a medical device, to which classification it belongs, or if a new classification must be created. KFDA may take up to 90 days to make such a decision.

Korean Documentary Requirements

As part of any application for product registration, KFDA requires that the sponsoring manufacturer of any U.S.-made medical devices provide its Korean importer with an original USFDA Certificate to Foreign Government (CFG). The CFG must be an original, which includes the brands as well as the model or catalog numbers of all products submitted for approval. While U.S. Regulations allow for minor additions and changes to previously approved products without further approval, KFDA requires an updated, original CFG when even minor changes are made to devices. U.S. firms often find Korea's certificate requirement to be burdensome in terms of delays and additional costs when exporting their products to Korea. However, in cases where changes to a product's catalog or model numbers are for administrative purposes only and are not due to modifications of the product itself, KFDA will accept an existing CFG accompanied by a foreign manufacturer's statement to this effect, notarized by a U.S. state government.

KFDA does not have a system for auditing and verifying company records on product changes, and views the requirement for accurate, updated CFGs as necessary in order to preclude the possibility of fradulent applications (specifically, to prevent local importers from seeking medical device approvals without the foreign supplier's authorization through the use of altered or forged CFGs). The requirement that the CFG list catalog or model numbers is also used for Korean customs clearance purposes: Once a product has been approved, the model or component numbers are entered into a computer registry with which Korean Customs checks the approval status before it clears an import shipment.

Two Pathways for Obtaining KFDA Marketing Clearance

A) Class I Devices - Premarket Notification: Class I devices are subject to premarket notification, which requires KFDA's documentary review of product information. No product testing is required in Korea for Class I devices. To apply, your Korean importer will complete a "Pharmaceutical Affairs Act Implementing Regulations Attachment Form 15-2" and will submit this form with your supporting literature to the KFDA District Office responsible for the region where your importer's main office is located:

A completed Form 15-2 must list the following information:

A KFDA District Office may take a maximum of 10 working days to determine whether it will accept the notification or require additional information. In the case of acceptance, KFDA issues a certification of completed notification, which will permit your Korean importer to begin commercial importation of the product.

B) Class II and III Devices - Premarket Approval: Class II and III devices are subject to premarket approval, for which KFDA performs a more rigorous documentary review followed by a product "type test" in a KFDA-authorized local lab.

Step 1 - Technical Review:

The first step for approving Class II and III devices is to file a completed "Pharmaceutical Affairs Act Implementing Regulations Attachment Form 17-2", entitled "Standards and Testing Method (STM) Review Application" with KDFA's Medical Device Evaluation Department. The purpose of STM Review is to evaluate the manufacturer's quality standards for materials or finished products through the following information requested on STM form 17-2:

In most cases, KFDA receives products for evaluation that are essentially the same as those already in the market, and by current regulation, may take up to 55 working days to accept the STM application or to decide that additional information is required. KFDA generally requests that additional information be provided within 30 days. The 55-day "clock" on the processing of an application is suspended while requested information is pending. KFDA is flexible in accommodating firms' requests for additional time to prepare requested information. Once KFDA accepts a product through STM review, the product can then undergo a "type test" by a KFDA-authorized lab.

While reviewing an STM application, KFDA may require a Safety and Efficacy Review (SER) for any product with new-to-market features in terms of materials, mechanism of action, usage or effectiveness. SER is the most rigorous review process, analogous to the USFDA premarket approval (PMA). An SER review can take up to 90 days. An SER application should be prepared with the "Pharmaceutical Affairs Act Implementing Regulations Attachment Form 16, " in which the following information should be provided:

Step 2 - Type Testing

Testing of KFDA Class II or III medical devices is mandatory both before a product is approved, as well for quality assurance of import shipments after approval has been granted (see below for more information on post-registration "Quality Assurance Testing" ).

Once KFDA has completed an STM review and/or SER, a KFDA-authorized lab tests the product, or makes a determination that, based upon acceptable foreign test data, the product does not require local testing in Korea.

For tests that KFDA deems must be performed in Korea, Korean importers submit the KFDA-approved STM documents, foreign test reports and product samples to one of the labs which tests or reviews foreign test reports. Fees and the number of sample products required vary, depending on the nature of product and tests. These Korean labs' review and testing processes generally take one month. KFDA has eight authorized laboratories to test medical devices, with different areas of expertise as follow:

There are some conditions under which the test lab may decide at its discretion to recognize foreign test reports and to forgo local type testing of an imported medical device. Many U.S. Firms may already have in hand reports from tests conducted in the U.S. or elsewhere during the course of product development or foreign regulatory approval, which in some instances may be used by a Korean partner to reduce time and costs of getting products to market in Korea. Korean importers typically will ask U.S. manufacturers for one or more of the following test reports for a premarket approval application: biocompatibility, electrical safety, performance standards and clinical study, as follow:

i) Biological Safety Test Reports: KFDA's regulation entitled, "Common Standards Regarding the Biological Safety of Medical Devices" (KFDA Notification No. 2000-13), outlines the specific types of biological safety reports that may be required for product approval, depending on the nature of the product and length of contact with the human body. The extensiveness of the regulations seems consistent with U.S. Regulations, although there may be some differences in applying regulations on a case-by-case basis. All reports from test conducted on animals must comply with Good Laboratory Practices (GLP). A U.S. test report accepted in lieu of local testing typically shows a GLP statement in the cover page of the report. A summary report in original is most preferred, and a notarized copy is also acceptable. Among U.S. labs whose test reports are often accepted by local labs are North American Science Associates, Inc. (NamSa), Toxikon Corporation, BEC Laboratories, Northview Laboratories and VIROMED Laboratories.

ii) Electrical Safety Test Reports: KFDA requires that all electronic medical devices comply with International Electrotechnical Commission (IEC) safety standards. All devices must meet IEC 601-1, and certain devices must meet the more specific standards of IEC 601-2. In order for a foreign-made device to be exempt from local testing, its test report must be submitted in the "CV scheme" form. Original report documents are preferred, but notarized copies are accepted. If the device manufacturer conducted the test at an in-house lab, a corporate test report may be accepted if submitted with a notarized statement attesting to the veracity of the contents.

iii) Performance Reports: When a foreign manufacturer's performance standards are based on consensus standards mentioned above, the tests reports by foreign labs based on those standards should be acceptable in place of local testing. U.S. Manufacturers frequently develop proprietary standards and test methods, in which case the manufacturer's notarized test reports may be acceptable. If such test reports are not available, a local lab may be able to conduct the test. If the local lab lacks the necessary equipment, the manufacturer may be required to choose alternative standards or test methods that are replicable locally.

There is no list, as such, of all standards or test methods acceptable for approval in Korea, KFDA's acceptance of foreign standards and test reports is determined on a case-by-case base. However, there are certain standards KFDA has frequently accepted as follows:

-- Local Standards: At present, KFDA has established standards for only 76 of its 950 device classifications; these standards serve as the lower limit criteria for approval of a product. With many KFDA standards not yet established, a particular product may meet other standards and doesn't necessarily have to fit into KFDA's pre-determined standards. KFDA also has regulations for radiation safety regulations that apply to all radiation-emitting devices. When applicable, medical devices are also subject to electromagnetic interference regulations imposed by Korea's Ministry of Information and Communication. Other national standards, such as Korean Pharmacopoeia and Korean Standards (KS), are also frequently referenced for device approval.

-- Foreign Standards: KFDA generally accepts for approval internationally-accepted standards or equivalents in terms of level of sophistication, including national standards of some advanced countries or consensus standards. Among these are those of the International Standards Organizations (ISO), American Society for Testing and Materials (ASTM), International Electrotechnical Commission (IEC), U.S. Pharmacopoeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP).

-- Proprietary Standards: KFDA reviews and accepts corporate proprietary standards on a case-by-case basis. In general, KFDA accepts such standards when the agency can recognize that the level of proprietary standards is equivalent to or higher than applicable consensus standards.

Post-Registration "Quality Assurance Testing"

Once KFDA approves a medical device, every import shipment of a Class II or III device must be tested locally before the products can be offered for sale. This testing requirement is separate from the type testing requirement that is part of the initial product registration process (described above). However, a product can also be exempted from most of this local quality assurance test if the U.S. manufacturer is in compliance with the U.S. Quality System Regulations (QSR). Upon submission of a CFG issued by USFDA to a U.S. Manufacturer, KFDA recognizes the firm to be compliance with QSR and, thus, exempt from most or all of the of the locally-required tests. In this case, local imports are only subject to visual inspections or checks for Korean-language labels. The CFG used must be an original USFDA document, not a photocopy.

Similarly, KFDA also accepts a certificate of a foreign manufacturer's CE Compliance in place of the quality assurance test for products made in the European Union. Upon submission of the original certificate or a notarized photocopy issued by a EU-designated Notified Body (NB), products manufactured in EU countries are exempt from most local testing in the same manner as that described above for U.S. products. This CE mark-based exemption applies only to products manufactured in EU countries: A CE-marked product manufactured in a non-EU country is not eligible for exemption based on a CE certificate; rather, it can only obtain exemption based on documentation from the country where it is manufactured.

Clinical Trials

When clinical trials are required, foreign clinical studies may be accepted in lieu of local trials. KFDA requires that such studies be conducted according to Good Clinical Practices (GCP). KFDA's preference is a final report of a clinical study published by a reputable professional journal listed on the Science Citation Index. However, KFDA will review unpublished study reports to determine acceptability, depending on GCP compliance and the reputation of the research organization involved.

Effective Review Periods

As described above, the official maximum review time at KFDA is 55 business days for regular Class II or III devices, or 10 business days for Class I devices. For devices incorporating new-to-Korea materials or technologies, Korean regulations allow up to 90 days' additional review. According to anecdotal reports, a Korean distributor with regulatory staff of reasonable experience and quality typically takes 6-8 months to obtain KFDA approval for Class II or III devices, and 1-3 months for Class I devices, from the time it has received necessary supporting documents from a U.S. device supplier. (In-house time required for manufacturers to prepare registration dossiers can push these periods into the range of 6-12 months).

Typical Costs of Registration

KFDA's actual in-house registration fees themselves are fairly inexpensive. However, test fees for Korean laboratories vary, and can be substantial. Total costs for product approval vary depending on the class and nature of products, and can range from less than $100 to as much as $7,000. Costs for a special product may exceed this range, if more extensive testing is required for approval. Below is a cost breakdown for a typical case. (Please note that fees are charged to a single application that may include multiple models under one product group):

Class I: Review fee for KFDA - Korean Won 500 (less than 40 U.S. cents)

Class II, III:

Class I, II, and III: Technical review of new-to-Korea devices: Korean Won 30,000 (US$24)

Anticipated Regulatory Changes

KFDA has directly regulated medical devices for only about four years. The agency maintains regulations for approvals in general terms and has not had in place normative documents providing details required for approvals specific to products, a situation which has resulted in confusion among manufacturers regarding specific requirements. Draft legislation expected to be considered by the National Assembly sometime during 2002 is expected to codify better some of these regulatory procedures. The draft "Medical Devices Act" would aim to codify Korea's regulation of medical devices under legislation distinct from the Pharmaceutical Affairs Law under which Korea's regulation of medical devices has been developed. Key provisions of the draft Medical Devices Act would:

KFDA is also known to be considering whether to introduce a Third-Party review process for lower and/or intermediate-risk devices, either through the Medical Devices Act or separately. The precise timetable for consideration of the draft Medical Devices Act has not been established, but we will attempt to provide updates as developments warrant.

Contacts

Korea Food & Drug Administration
Medical Devices & Radiation Health Department
Mr. Lee, Hai Kwang, Director, Medical Device Standards Division
Mr. Lee, Sang-Yeul, Director, Medical Devices Division
5 Nokbun-dong, Eunpyung-ku,
122-704 Seoul, Republic of Korea
Tel: 82-2-380-1754 / 82-2-380-1519
Fax: 82-2-351-3726 / 82-2-388-6394
e-mail: m_kfda@kfda.go.kr

U.S. Commercial Service Office - United States Embassy in Korea
82 Sejong-ro, Chongro-ku
Seoul 110-710, Korea
Tel: 82-2-397-4505
Fax 82-2-739-1628
e-mail: seoul.office.box@mail.doc.gov

Appendix 1: For more information, read the 2005 Commercial Service "Korea Market Brief for the AACC Clinical Lab Expo 2005 in Orlando".