The Republic of Korea, a country with over 50 million people situated in the Korean Peninsula extending from mainland Asia to the east, borders the coasts of the Yellow Sea, East Sea, the Korea Strait, and the East China Sea. Its geography ranges from high mountain ranges and hills to coastal plains, river basins, and valleys to approximately three thousand islands. South Korea is a presidential republic based in the capital, Seoul, which is home to 10 million people, making it one of the largest cities in the world. Seoul is a highly advanced technology centre and economic powerhouse. It hosts the sixth largest number of Fortune Global 500 companies in the world.
A member of the OECD, South Korea has one of the highest standards of living in the world and a highly developed economy, ranking in the top five economies in Asia and among the G-20 major economies of the world. Due to the lack of natural resources, South Korea is one of the largest exporters in the world for products such as electronics, automobiles, petrochemicals, and robotics, which drive a large percentage of the economy. In addition, the export of medical devices has risen dramatically, increasing by 17.5% from 2011-2012 and valued at USD $2.6 billion. Despite the fact that it is export-driven, South Korea was able to recover very quickly from the global financial crisis of 2008 and is projected to grow at 4.6% on average over the next five years. In 2013, it is estimated that overall GDP was USD $1212 billion.
59% of healthcare in South Korea is funded by the public sector with one of the highest healthcare expenditures in Asia and a public health insurance system. Healthcare costs are rising as the population ages and the average age nears 40, spurring spending cuts and some relaxation in regulations in recent times. In 2011, 7.2% of GDP was spent on healthcare at USD $2181 per capita.
Medical device registration in South Korea is complex and sometimes cumbersome especially for foreign manufacturers. However, recent free trade agreements with the EU and the USA may result in more transparency in the registration process. In September of 2013, South Korea relaxed regulations for Class I (low-risk) devices, a change that has been received with favour as it reduces the time and cost of Class I device registration.
THE GOOD NEWS:
Class I device registration has recently been relaxed and can be completed online almost instantaneously.
THE CHALLENGE:
The authorities in South Korea have particular requirements that demand attention to detail.
Medical devices and in-vitro diagnostic (IVD) devices are regulated and registered in South Korea through the Korean Ministry of Food and Drug Safety (MFDS). South Korea classifies medical and IVD devices into four categories: Class I, II, III, or IV. Class I medical devices require pre-market notification, which is a process similar to obtaining a CE Mark for a Class I device in the EU and can be completed online.
All submissions require the submission of a Technical Construction File (TCF) that includes all technical information pertaining to the device under review. In the case of Class I devices, the TCF must be submitted (excluding raw materials and test standards sections) but the review process is expedited and less demanding. Class II, III, and IV medical devices require full pre-market registration from the MFDS. The MFDS only recognizes testing conducted by particular bodies. If the TCF is submitted with testing certification from an unrecognized body, the MFDS will require that the testing be performed again either by a recognized testing body or in South Korea.
A local authorized representative is required to obtain a license. Though an independent third party may act as the representative, they will be regarded as an importer of the manufacturer and will therefore be responsible for quality control and post-market activities of the product.
All medical device manufacturers must obtain Good Manufacturing Practice (GMP) certification before registered devices are distributed in South Korea, though Class I devices are exempt from this requirement as of September 2013. The license holder may import the device if it is registered but may not distribute it until a GMP certificate is obtained. However, if a medical device licensed by the MFDS does not comply with the GMP requirement within one year from the time the license is issued, the license will be cancelled by the MFDS. Once issued, the GMP certificate is valid for three years and should be re-audited once that period has ended. The MFDS will review quality management records of the device, QMS documents, and related records from the previous three years.
Until December 31st 2013, the GMP audit for Class II devices is performed by document review only. After that date, the audit will include on-site inspection as with Class III and IV. In addition, it is very likely that a proposal requiring GMP certification to be completed prior to device registration will be passed in early 2014. Other changes to the regulations for medical devices are also under discussion.
Registration in South Korea takes up to five months to complete with an additional two to three months to obtain a GMP certification. Once an importing or manufacturing license has been obtained, the MFDS does not have an official expiration date. However, a mandatory re-evaluation takes place every three years and the manufacturer is typically notified one year in advance. For Class I devices, the license is issued immediately after submission of the TCF without a review process.
WHAT YOU NEED TO KNOW:
Registration in South Korea can be completed in less than five months after GMP certification has been obtained. Recently, Class I device registration has been streamline to exclude GMP requirements and further changes are pending. A local authorized representative is required and re-evaluation typically occurs every three years.
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