Medical Device Registration in Korea: An Overview
The Latest Primer Explores How to Navigate the Regulatory Process
in This Emerging Market
| Ames Gross
As in Japan, though, potential sales are accompanied by a complicated regulatory environment. This article briefly describes the process of registering a product in Korea.
Laws and Administration
Since 1997, medical devices have been regulated by the Korea Food and Drug Administration (KFDA). The KFDA is an independent agency under the supervision of the Ministry of Health and Welfare. Previously, the governing law for medical devices was the Pharmaceutical Affairs Act, which also covered drugs. However, to better cover medical devices and speed harmonization, the new Medical Device Act was passed in 2003. It went into implementation in 2004, and full enforcement will begin May 30 this year.
Basic Caveats on Registration
Under Korean laws, a foreign manufacturer without a Korean office may not directly submit a device registration application to the KFDA, but the company may allow its importer to do the registrations. The manufacturer also may hire an independent third party based in Korea to make the registrations in its own name.
In addition, Korea does not allow devices into the country if they have not been approved in their country of manufacture. A Certificate to Foreign Government or Free Sale Certificate is an integral part of a foreign product’s application.
Three processes are required to get a device registered in Korea: a product license; Korean Good Manufacturing Practice (KGMP) certification; and a Device Business License. Of these, the KGMP certification must be renewed every three years. The other two are valid permanently, although changes may require re-registration.
Devices are divided into four classes, with Class I being lowest risk and Class IV being highest risk. A strict system of more than 1,000 classifications segments devices into those four classes; however, there are plans to expand the number of classifications in the near future.
Product License: Class I
The procedure for Class I devices is relatively simple: only notification is required, not approval. The applicant simply submits a standard notification to a KFDA District Office. This notification includes information on the product, its manufacturer or importer, its classification, purpose of use, instructions for use, raw materials and specifications, dimensional drawings, precautions and the labeling to be used. Once it is submitted, the District Office will issue an acceptance letter, which is equivalent to a product license in this case.
Product License: Classes II-IV
Classes II, III and IV devices need to go through a full review and approval process. Approval in the country of origin can speed up the process somewhat but is not sufficient in itself for product registration in Korea. On the other hand, some progress in efficiency has been made by the admission of third-party review organizations into the process. The two main requirements for a product license are a technical file and type testing.
The general technical file’s requirements are broadly similar to that of a 510(k) submission in the United States. It is used when a similar device already has been approved. There is a one-page application form that contains much of the same material as in the notification form for Class I devices but requires additional attachments detailing further information. These attachments include information on physical and chemical characteristics, electrical safety and performance, among others—all supported by test reports.
The SER technical file is required for more novel devices. Besides the general file requirements, it includes information on the development process, stability reports and comparative analysis with other devices. In addition, it requires clinical study reports.
The KFDA does accept foreign clinical trials for approval—not necessarily needing local ones—but there are criteria for consideration of these trials. They must be published in a prominent medical journal (the Science Citation Index is one arbiter of prominence), or else they must have been accepted by the government of the country of manufacture for its own approval procedure. In the latter case, documentation of that acceptance in the foreign country should be attached.
Clinical trials are only required as a rule for SER technical files, but the KFDA also may require them at its discretion for general technical files.
The technical file must be reviewed and approved. If it is a Class II or III product and does not require an SER file, a third-party organization can do this. A review by the KFDA takes two to three months. Reviews by third-party organizations, in contrast, take only about one month, although they cost more (about $350 compared to $30-$40 for the KFDA).
Besides the technical file, the other requirement for a product license is type testing. Only third-party labs do this, not the KFDA. It requires submission of samples and the technical file. If the technical file has not yet been officially approved, a draft technical file can be submitted instead. Type testing takes one to three months, with fees ranging from $3,000 to $10,000, all depending on the type of device. At the completion of testing, the lab will issue a certificate of compliance.
To lower fees and review time, it also is possible to submit equivalent test reports done abroad and have them validated for a fee of about $800. However, the foreign testing must meet certain international standards.
Applying for a Product License
Once both technical file review and type testing are complete, the technical file (with approval) and certificate of compliance must be submitted to the KFDA. Attached should be a list of the applicant’s facilities in Korea and (for foreign devices) a free sale certificate from the device’s country of manufacture. After reviewing all of these, the KFDA will issue a Product License, which does not expire.
Device Business License
This license, similar to the US Certificate of Device Establishment, can be obtained by submitting one Product License and other information on the company (facilities, business registration and health certificate for its representative). It does not expire. Of course, an importer typically would have such a license already for other products.
A company applies for KGMP certification by way of a third-party inspection organization. This organization does not do the entire inspection but assists the KFDA inspectors in much of their work. The process takes about one month from application and costs about $1,000, depending on the size of the company. The certificate is valid for three years.
In the case of foreign manufacturers without an office in Korea, only the importer undergoes inspection, but it needs documentation from foreign manufacturers to demonstrate its compliance. Some token manufacturing or importing must be done to produce a paper trail demonstrating compliance, even if the device cannot be sold yet.
Once these three licenses have been obtained—Product License, Device Business License and KGMP Certification—it is finally legal to market a medical device in Korea. Beyond regulatory permission, there are other important processes as well, such as obtaining reimbursement from Korea’s national health insurance system, as well as post-market surveillance requirements.
Dealing with the Korean regulatory structure can be tricky and requires expertise on the ground. Communication and consultation with officials is necessary at many stages, and officials will not discuss applications in English. However, these are not reasons to stay away—but reasons to be deliberate and patient in entering this key Asian market.