Korea’s Ministry of Food and Drug Safety (MFDS) has issued a draft revision to the Enforcement Rule of the Medical Devices Act that would streamline device change procedures and update several regulatory requirements.
The revision introduces the “negative list” system for device change approval. Under this approach, prior approval would only be required for changes that could significantly affect a device’s safety or performance. Examples of such changes include modifications to intended use, mechanism of action, materials, or manufacturing sites. Other changes could be managed internally by manufacturers based on their change management procedures submitted during the initial approval process.
Additionally, when manufacturers receive conditional approval requiring GMP compliance within a specified timeframe, the MFDS will reduce the verification period from 20 days to 10 days. This change is intended to help companies launch products more quickly.
Additional revisions clarify recall criteria and administrative procedures. Devices may be recalled if they fail to meet either standard specifications or approved testing specifications identified during post-market inspections. Finally, the rule will allow regional authorities to disclose investigation results when foreign substances are found in medical devices.
These changes are expected to shorten approval timelines for device modifications while maintaining regulatory oversight.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.