South Korea With a market size of $3.6 billion, South Korea has the third-largest medical device ma

South Korea
With a market size of $3.6 billion, South Korea has the third-largest medical device market in Asia, after Japan and China. Thanks in large part to a population of more than 48 million people, South Korea’s medical device market is expected to grow by about 5-7 percent during the next five years.

The Korean Food and Drug Administration (KFDA) decided in April that it would overhaul its Medical Device Act. The expectation is that once the regulations are revamped, the registration and approval of medical devices will become more transparent and predictable. The revisions also include detailed requirements for Class II to Class IV medical devices. Revisions include:

The length and complexity of the approval procedures of pre-market medical devices in Korea have changed. The time to register devices with a low risk level has been shortened, and their requirements have been simplified. Third-party bodies now are responsible for reviewing some Class II devices, many of which are well-known or “me-too” devices.

Technical review of Class III and IV devices is mandatory. Devices with substantial equivalency (SE) to other products that already have been approved in Korea have different requirements than non-SE
devices. SE devices do not require their own clinical reports. Non-SE devices, however, require their own clinical reports. If foreign clinical reports are deemed sufficient by the KFDA, no local clinical studies will be required in Korea.

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A new certification system is in effect for foreign medical device manufacturers. If a foreign device has been approved by the KFDA before April 8, 2012, the KFDA will grant a KGMP certificate to the foreign manufacturer without additional requirements. The Korea Good Manufacturing Practice (KGMP) certificate first will be given to the importing company, which then will transfer the certificate to the foreign manufacturer. However, if there is a new product, or if an existing foreign manufacturer has a new manufacturing site, an on-site inspection or a document review will be required for the manufacturer to get KGMP-certified.

In the past, many foreign device companies had to duplicate tests in Korea for product registration. But foreign test reports and manufacturer studies that are conducted by good laboratory practice labs and comply with international standards (e.g., ISO 10993, ASTM International, U.S. Pharmacopeial Convention standards, etc.) now will more easily be accepted by the KFDA.

In-vitro diagnostics will be regulated as medical devices starting Jan. 1, 2013.