Ames Gross11.09.12
South Korea is among the world’s leading economies with a gross domestic product that ranked 15th in the world in 2011, according to the International Monetary Fund. Benefiting from a growing economy and population of more than 48 million people, the healthcare market in Korea is expected to continue to expand. A recent report by the Korea Drug Research Association showed that the Korean medical device market is worth more than $3 billion with an expected annual growth rate of 10 to 15 percent during the next five years.
In order to better regulate the growing medical device market, the Korean Food and Drug Administration (KFDA) made significant changes in 2011 to the original Medical Device Act.
Regulatory changes of the revised act were fully enforced in April this year. Major changes include restructuring the pre-market approval process for medical devices; introducing a new Korea Good Manufacturing Practice (KGMP) Certification system for foreign manufacturers; regulating in-vitro diagnostics (IVD) products as medical devices; and accepting more foreign data in the medical device approval process.
New Pre-Market Approval Processes
The KFDA has redesigned the medical device pre-market approval process around the level of risk associated with the medical device. According to the new requirements, low-risk products only need to go through a simplified registration procedure, while higher risk medical devices now have a more stringent review process.
The KFDA has introduced a new Notification Listing System for Class I medical devices. Under the new regulations, most Class I medical devices are exempted from technical review and KGMP certification procedures. The exceptions to this are Class I sterile and measuring devices, which are regulated in the same way as Class II devices. With this new Notification Listing System, Class I medical device manufacturers can complete product registration after uploading registration information onto the KFDA electronic portal.
For Class II medical devices, pre-market approval procedures mainly depend on the device’s level of substantial equivalency (SE) with previously approved products. Medical devices are divided into four categories according to the KFDA SE standards: Announced Equivalent product, Equivalent product, Improved product, and Novel product. Announced Equivalent products are not subject to technical document review. Medical devices in the other three SE categories must go through the technical documents review process. Definitions and criteria to determine SE categories can be found in the revised Medical Device Act and on the KFDA website (www.kfda.go.kr/eng).
Approval processes for Class III and IV medical devices were made stricter with the new regulations. The revised Act stipulates that all Class III and Class IV medical devices are subject to technical document review. Specific information required, however, can vary according to the level of substantial equivalency of the device. For non-SE risky medical devices, the KFDA mandates that manufacturers submit clinical reports on these non-SE devices. For SE medical devices, the KFDA may accept clinical reports completed on similar products.
New KGMP Certification for Foreign Manufacturers
The KFDA established a new Korea Good Manufacturing Practice Certificate for foreign medical device manufacturers. A KGMP Certificate is required for all foreign manufacturers of Class II, III, and IV medical devices. Class I device manufacturers are exempt from this requirement.
Current manufacturers who already had their products approved by the KFDA before April 8, 2012, will be granted a KGMP Certificate automatically. The KGMP Certificate for these manufacturers will be valid through the remaining period of the Korea Good Import Practice Certification that the importer holds. However, a new KGMP Certificate may be required if these current manufacturers register new products in a new category or register a new manufacturing site.
In order to apply for a KGMP Certificate, a local importer will need to submit the application on behalf of the foreign medical device manufacturer. After receiving the application materials, the KFDA will then determine whether to conduct an on-site inspection or conduct only a document review. Currently, the KFDA plans to perform approximately 20 to 30 on-site inspections per year, and will approve most other KGMP Certification applications through a document review only.
New Regs for IVD Products
Per the revised Medical Device Act, the KFDA will regulate in-vitro diagnostics as medical devices starting from Jan. 1, 2013. Previously, some IVD instruments were regulated as pharmaceuticals in Korea. In order to regulate IVD products, the KFDA has set up an IVD task force to review applications for in-vitro diagnostics products.
Broader Data Acceptability for Medical Device Registration
As part of the efforts to improve Korea’s regulatory integration with international standards, the KFDA has increased acceptance of foreign clinical data in the medical device registration process.
Under the new regulations, foreign biological tests conducted in accordance with international standards such as ISO 10993 and U.S. Pharmacopeial Convention standards will be accepted by the KFDA. The KFDA also may accept biological test reports conducted with a comparable product. The KFDA will continue to accept foreign clinical reports that have been published in an academic form.
While local clinical tests are not required for most cases where foreign data are robust, the KFDA retains the right to request a local clinical study where it deems necessary.
Other Regulatory Changes
The KFDA also introduced a new expedited review process for medical device registration. Devices utilizing novel technology and orphan devices now are eligible to apply for expedited review. The KFDA will conduct consultation meetings with manufacturers of medical devices approved for expedited review, and offer more streamlined guidance in terms of product registration.
In addition, the new Medical Device Act listed new restrictions on medical devices going through the registration process. Incomplete applications no longer will be considered. Unlike prior cases, the KFDA no longer will issue notices requesting additional information if the application is incomplete. Additionally, medical devices for which the product license has been revoked within one year will not be approved. Another restriction is that medical devices with misleading or inaccurate brands and names will not be approved.
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The new KFDA regulations will improve transparency and predictability for medical device registration requirements in Korea, despite the fact that they are more stringent for risky medical devices. Implementation of the new regulatory changes will enable the Korean population to access safer and higher-quality medical devices. The KFDA’s broader data acceptability also will increase the ease of entering the Korean market for Western medical companies.
Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical device companies succeed in Asia. A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia. For more information, visit www.pacificbridgemedical.com.
In order to better regulate the growing medical device market, the Korean Food and Drug Administration (KFDA) made significant changes in 2011 to the original Medical Device Act.
Regulatory changes of the revised act were fully enforced in April this year. Major changes include restructuring the pre-market approval process for medical devices; introducing a new Korea Good Manufacturing Practice (KGMP) Certification system for foreign manufacturers; regulating in-vitro diagnostics (IVD) products as medical devices; and accepting more foreign data in the medical device approval process.
New Pre-Market Approval Processes
The KFDA has redesigned the medical device pre-market approval process around the level of risk associated with the medical device. According to the new requirements, low-risk products only need to go through a simplified registration procedure, while higher risk medical devices now have a more stringent review process.
The KFDA has introduced a new Notification Listing System for Class I medical devices. Under the new regulations, most Class I medical devices are exempted from technical review and KGMP certification procedures. The exceptions to this are Class I sterile and measuring devices, which are regulated in the same way as Class II devices. With this new Notification Listing System, Class I medical device manufacturers can complete product registration after uploading registration information onto the KFDA electronic portal.
For Class II medical devices, pre-market approval procedures mainly depend on the device’s level of substantial equivalency (SE) with previously approved products. Medical devices are divided into four categories according to the KFDA SE standards: Announced Equivalent product, Equivalent product, Improved product, and Novel product. Announced Equivalent products are not subject to technical document review. Medical devices in the other three SE categories must go through the technical documents review process. Definitions and criteria to determine SE categories can be found in the revised Medical Device Act and on the KFDA website (www.kfda.go.kr/eng).
Approval processes for Class III and IV medical devices were made stricter with the new regulations. The revised Act stipulates that all Class III and Class IV medical devices are subject to technical document review. Specific information required, however, can vary according to the level of substantial equivalency of the device. For non-SE risky medical devices, the KFDA mandates that manufacturers submit clinical reports on these non-SE devices. For SE medical devices, the KFDA may accept clinical reports completed on similar products.
New KGMP Certification for Foreign Manufacturers
The KFDA established a new Korea Good Manufacturing Practice Certificate for foreign medical device manufacturers. A KGMP Certificate is required for all foreign manufacturers of Class II, III, and IV medical devices. Class I device manufacturers are exempt from this requirement.
Current manufacturers who already had their products approved by the KFDA before April 8, 2012, will be granted a KGMP Certificate automatically. The KGMP Certificate for these manufacturers will be valid through the remaining period of the Korea Good Import Practice Certification that the importer holds. However, a new KGMP Certificate may be required if these current manufacturers register new products in a new category or register a new manufacturing site.
In order to apply for a KGMP Certificate, a local importer will need to submit the application on behalf of the foreign medical device manufacturer. After receiving the application materials, the KFDA will then determine whether to conduct an on-site inspection or conduct only a document review. Currently, the KFDA plans to perform approximately 20 to 30 on-site inspections per year, and will approve most other KGMP Certification applications through a document review only.
New Regs for IVD Products
Per the revised Medical Device Act, the KFDA will regulate in-vitro diagnostics as medical devices starting from Jan. 1, 2013. Previously, some IVD instruments were regulated as pharmaceuticals in Korea. In order to regulate IVD products, the KFDA has set up an IVD task force to review applications for in-vitro diagnostics products.
Broader Data Acceptability for Medical Device Registration
As part of the efforts to improve Korea’s regulatory integration with international standards, the KFDA has increased acceptance of foreign clinical data in the medical device registration process.
Under the new regulations, foreign biological tests conducted in accordance with international standards such as ISO 10993 and U.S. Pharmacopeial Convention standards will be accepted by the KFDA. The KFDA also may accept biological test reports conducted with a comparable product. The KFDA will continue to accept foreign clinical reports that have been published in an academic form.
While local clinical tests are not required for most cases where foreign data are robust, the KFDA retains the right to request a local clinical study where it deems necessary.
Other Regulatory Changes
The KFDA also introduced a new expedited review process for medical device registration. Devices utilizing novel technology and orphan devices now are eligible to apply for expedited review. The KFDA will conduct consultation meetings with manufacturers of medical devices approved for expedited review, and offer more streamlined guidance in terms of product registration.
In addition, the new Medical Device Act listed new restrictions on medical devices going through the registration process. Incomplete applications no longer will be considered. Unlike prior cases, the KFDA no longer will issue notices requesting additional information if the application is incomplete. Additionally, medical devices for which the product license has been revoked within one year will not be approved. Another restriction is that medical devices with misleading or inaccurate brands and names will not be approved.
* * *
The new KFDA regulations will improve transparency and predictability for medical device registration requirements in Korea, despite the fact that they are more stringent for risky medical devices. Implementation of the new regulatory changes will enable the Korean population to access safer and higher-quality medical devices. The KFDA’s broader data acceptability also will increase the ease of entering the Korean market for Western medical companies.
Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical device companies succeed in Asia. A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia. For more information, visit www.pacificbridgemedical.com.