Introduction
Korea is an important Asian destination for foreign medical devices. Its total medical device market in 2005 was about $2.5 billion. While this may seem low compared to China’s $5 billion, its health expenditure per capita in 2006 was $705, compared to China’s $61, according to the WHO. This means a greater proportion of the population can afford high-end medical treatment. Also, over 60% of its medical device market comes from imported products.
Like Japan, though, potential sales are accompanied by a complicated regulatory environment. This article briefly describes the process of medical device registration 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 (MOHW). 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 on May 30, 2007.
Basic Caveats on Registration
Under law, a foreign manufacturer without a Korean office may not directly submit a Korea medical device registration application to the KFDA. Foreign manufacturers may allow their importer to do the registrations. They may also hire an independent third party based in Korea to make the registrations in their own name.
Also, Korea does not allow devices into the country that 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.
Registration Structure
There are three processes required to get Korea medical device registration: 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, Class I being lowest risk and Class IV being highest risk. There is a strict system of over 1,000 classifications dividing devices up into those four classes, although 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 Korea medical device registration. 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.
Technical File
The first requirement for a product license is the submission of a technical file. These fall into two categories: the general technical file and the safety and effectiveness review (SER) technical file.
The general technical file’s requirements are broadly similar to that of a 510(k) submission in the US. It is used when a similar device has already been approved. There is a one-page application form, containing much of the same material as in the notification form for class I devices, but requiring 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 second 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 may also 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 2 to 3 months. Reviews by third-party organizations, in contrast, take only about 1 month, although they cost more (about $350 compared to $30-40 for the KFDA).
Type Testing
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 1-3 months, with fees ranging from $3,000-10,000, 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 is also 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 will typically have such a license already for other products.
KGMP Certification
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 3 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.
Completion
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 regulatory structure for a Korea medical device registration 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.
Ames Gross – President and founder. Mr. Gross is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross founded PBM in 1988 and has helped over 200 medical companies with business development and regulatory issues in Asia.
John Minot – Associate. Mr. Minot graduated with a B.A. in Government and East Asian Studies from Cornell University. He works on research and writing projects and speaks Japanese.
Pacific Bridge Medical is a leading independent consulting firm dedicated to assisting medical companies in Asia. To learn more, please visit our website at www.pacificbridgemedical.com.