This new law applies to SaMD (Software as a Medical Device), pharmaceutical agents combined with digital technology, and digital devices for health improvement and wellness.
The overall technical review as well as final approval for the products falling under Class 1 and 2 will be conducted by the NIDS, with an official review timeframe of 65 working days.
For Class 3, Class 4, and Not Substantially Equivalent products, review and approval will be handled by the MFDS, with an 80-day review timeframe.
Submission of a Sustantial Equivalent (SE) Table to compare the product with a Korean predicate device is not required to register a product falling under this Act.
A different rule applies to classify a digital healthcare product, and a determination process with the MFDS can be initiated to clarify the classification.
If required, real-world clinical data can be used to substantiate the clinical safety and efficacy of the product.
A separate KGMP (Korea Good Manufacturing Practices) system will be operated for digital healthcare products.
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