Broader Data Acceptability for Medical Device Registration As part of the efforts to improve Korea&

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.