Korea’s MFDS Sets the Stage for a New Era in Medical Device Certification

South Korea's MFDS Certification update

A draft guideline from Korea’s Ministry of Food and Drug Safety is already generating tremendous hype (medical device) buzz. The proposal represents a very clear move towards closer harmonisation with the US FDA, EU MDR rule set and more general alignment with the expectations of IMDRF. For businesses operating within the import export channel or managing global submissions, this announcement is not just another regulatory memo; it speaks at a strategic level that Korea are raising their standard for quality and evidence based approval.

The guidance is particularly pertinent for Class II and Class III devices, such as SaMD, which remains one of the fastest growing sectors in healthcare technology. MFDS opened a public commentary period for comments and recommendations, which ends today. When confirmed, the changes will influence Korean medical device certification from Q1-2026.

Why Korea Is Moving Toward Global Alignment

Across the world, regulators are trying to keep pace with rapid innovation in diagnostics, digital therapeutics, AI driven applications and high risk devices. Korea has long been considered a leader in adopting new technology, and this shift toward a more globally consistent ruleset is a natural next step.

For companies involved in medical device imports, the advantages are clear. A more predictable rule set means fewer surprises, clearer documentation pathways and a stronger connection to global standards. For manufacturers who already comply with FDA, MDR or IMDRF documents, this creates the opportunity to reuse scientific evidence, clinical data and safety documentation more efficiently.

At the same time, companies must prepare for a more rigorous review. MFDS is clearly signalling that it intends to raise expectations for safety, performance claims and ongoing monitoring once devices enter the Korean market.

What the Draft Guidelines Introduce

The draft introduces some significant changes that medical device manufacturers, ARs, Disti and RA teams will definitely need to be aware of in a clear manner.

1. The key first significant change is that now EU and UK IVD manufacturers are required to collect more clinical evidence, particularly in relation to higher risk products (and software products). The industry will be required to submit greater evidence of performance, risk reduction efficacy and post market safety results.

   
   

2. Second, customs-entered Korean devices will now be required to file PMS reports. This needs links imports to continuous monitoring of safety and allows MFDS a view on actual device performance in the field.

   
   

3. A third update is more around digital transformation. As of early 26, manufacturers will have to submit evidence packages and technical documentation directly via the MFDS digital gateway. For companies with a footprint across more than one market, this will mean enhanced documentation systems and greater integration within their QMS”.

   
   

4. Notably, MFDS has raised the maximum fines for non-compliance. It is also punishable by a fine of up to one hundred million Korean won, and in gross cases, import clearances could be suspended.

What This Means for Global Supply Chains

These changes will affect the way medical device companies handle regional approvals, importation processes, and long-term quality obligations. Entry products in Korea will need to deliver stronger documentation, less opaque QMS structure and improved cooperation between the regulatory quality and supply chain organizations.

These changes are also defining the future of device movement into Korea for companies doing business in Import Export Business. Clearance could be more predictable for businesses with compelling evidence and monitoring systems, although other clients may see extended lead times or unanticipated bottlenecks.

The worldwide medical device supply chain is already being strained by increased documentation needs in many areas. Korea’s convergence with the FDA and MDR takes this one step further, and companies should plan early.

How Companies Should Respond Right Now

Manufacturers are encouraged to review the draft guidance now and provide comments by the end of the consultation period. Regulatory and quality organizations should begin to map the new expectations against our existing evidence and QMS processes. Korea device sets should be evaluated so that submissions, which may require updated data and products affected by the new PMS clearance of requirements, can be sorted.

Teams working on imports should also find the shift to digital submission worth planning for now and saving themselves from delays once the new rules are in place.

Now would also be a good time for companies that rely heavily on distributors or authorised representatives in Korea to consider reminding the parties of their roles and responsibilities and back-to-back agreements.

How SLV 360 Supports Medical Device Companies

SLV 360 provides end-to-end guidance to medical device manufacturers navigating Korea’s evolving regulatory environment. Our team works closely with RA, QA and supply chain teams to interpret requirements, prepare aligned documentation for MFDS, structure PMS and vigilance programs and strengthen QMS systems so that they meet Korean and global expectations.

We support companies in the import export sector by reviewing technical files, preparing evidence packages, aligning FDA and MDR documentation for MFDS use and assessing Korea bound SKUs for regulatory impact. With our management consulting and business service expertise, we help organisations achieve readiness ahead of the twenty twenty six implementation period.

For companies entering Asia, Korea remains an important market, and proactive preparation will be essential.

For regulatory support or strategic guidance, you can reach us at info@spheralink360.com