The country of South Korea is one of the world’s leading economies — the 15th largest by GDP in 2012, and the fourth largest in Asia. With a growing economy, increasing wealth and an aging population of 49 million, Korea’s healthcare market will continue to expand. In 2011, the Korean medical device market had a value of $3.9 billion, according to the Korean Food and Drug Administration (KFDA). It is expected to grow 10 – 15 percent annually through 2018.
To cope with a growing medical device market, the KFDA amended the country’s Medical Device Act in April 2011. Changes include a restructuring of the pre-market approval process, an acceptance of more foreign clinical data, the reclassification of in-vitro diagnostics (IVD) products into the medical devices category, and the introduction of a new certification system for Korea Good Manufacturing Practice (KGMP).
Changes went into effect throughout 2012 and are still being implemented in 2013.
Korea’s pre-market approval process has been redesigned to reflect the risk classification of medical devices. For example, low risk products can now go through a simplified registration process, while the process for high risk medical devices is much more stringent.
Most Class I medical devices are now exempt from technical review and also from KGMP certification. Exempted Class I medical devices still need to be registered through a new notification system. With the new notification system, manufacturers simply have to upload their information to the KFDA’s online registration portal.
The only exceptions to this new rule are Class I sterile and some Class I measuring devices, which the KFDA regulates in the same way as it does Class II medical devices.
Class II medical devices are regulated depending on their levels of substantial equivalency (SE) with products previously approved by the KFDA. The KFDA has established a total of four SE categories: (1) Announced Equivalent, (2) Equivalent, (3) Improved and (4) Novel.
Announced Equivalent products are those specifically listed by the KFDA in light of similar product approvals. These devices do not have to go through technical document review to get product approval.
Equivalent, Improved and Novel products must all go through the technical document review process. The KFDA defines an Equivalent product as one equal to a previously approved product in intended use, operation principles, raw materials, performance specifications, test specifications and methods of use. An Improved product is similar, except that it is not equivalent in its performance specifications, test specifications or methods of use. Finally, a Novel product is wholly new to the market, and is not like a previously approved product in any of the above ways.
Under the revised act, Class III and Class IV medical devices are now subject to stricter standards of evaluation. The KFDA requires all Class III and Class IV products to undergo a technical document review, but required information varies according to the SE level of the device. For medical devices with some SE, the KFDA might accept clinical reports for similar products. But for non-SE, high-risk products, the KFDA requires clinical reports specific to the device being evaluated.
With the passage of the revised Medical Act, the KFDA has increased the acceptance of foreign clinical data during the medical device registration process. In order to integrate Korea’s regulatory structure with international standards, many more foreign tests are now accepted by the KFDA.
For example, foreign biological tests that have met ISO 10993 and the U.S. Pharmacopeial Convention will now be accepted. The KFDA may also accept biological test reports that have been conducted on comparable products. And the KFDA will still accept foreign clinical reports published by recognized scientific journals.
Although local clinical tests are not usually required if the foreign clinical data are comprehensive, the KFDA still holds the right to request local clinical studies.
IVD PRODUCTS REGISTRATION
From January 1, 2013 the KFDA has been regulating in-vitro diagnostics (IVD) products as medical devices. In the past, some IVD products were regulated as pharmaceuticals, while others were not regulated at all. To oversee all IVD applications, the KFDA set up a new IVD task force in 2012.
Foreign medical device manufacturers are now required to obtain KGMP Certificates for all Class II, Class III and Class IV medical devices. Class I medical device manufacturers do not need this certification.
Manufacturers whose products were approved before April 2012 were eligible for an automatic KGMP Certificate, valid for as long as the Korea Good Import Practice (KGIP) Certificate held by their importer. If a manufacturer should decide to register a new manufacturing site, or to register new products in a new category, they may have to obtain a new KGMP Certificate.
To apply for the KGMP Certificate, a local importer must submit the application for the foreign medical device manufacturer. After receiving all materials, the KFDA will decide whether to conduct only a document review or an on-site inspection. Manufacturers targeted for on-site inspections include those who are new to the Korea market, those who are introducing novel products, or those who have had past issues with quality or safety.
The KFDA plans to perform 20 to 30 on-site inspections per year, with some Class II inspections handled through third-party agencies. The KFDA will focus on Class III and Class IV site inspections in 2013. Most KGMP Certification applications, however, will be approved through document review alone.
ADDITIONAL REGULATORY CHANGES
Under the revised Medical Act, the KFDA has started an expedited review process for medical device registration. Orphan devices, devices utilizing novel technology and devices incorporating convergent technologies are all eligible for fast track review. In these cases, the KFDA will hold consultation meetings with manufacturers to offer streamlined product registration guidance.
Additionally, the KFDA is cracking down on manufacturers who violate standards or submit incomplete applications for device registration. The KFDA will no longer consider incomplete applications, and it will no longer issue notices requesting additional information. Medical devices with inaccurate or misleading names and brands will not be approved. Finally, medical devices that have had product licenses revoked within one year of application will not be approved.
Although the new KFDA regulations are more stringent for high-risk medical devices, they will improve predictability and transparency for medical device registration in Korea. In addition, the KFDA’s broader data acceptability should make it easier for foreign medical device companies to enter the market. This is especially true for manufacturers who take the time to do applicable test reports according to global standards.
The new regulatory changes will give foreign medical companies more opportunities in Korea.