Faster Access to Clinical Use

This policy fundamentally restructures procedures that previously took up to 490 days or more, including the New Health Technology Assessment (nHTA).

Under the new framework,

• If the Health Insurance Review and Assessment Service (HIRA) determines the product is a new medical technology after MFDS approval,
• Clinical use can begin in as little as 80 days (with up to 30 additional days, if needed).

Technologies Covered

The program applies to 199 product categories, including:

• Software as a Medical Device (SaMD) under the Digital Medical Products Act
• In vitro diagnostic reagents under the IVD Act
• Medical robots under the Medical Device Act

This reflects Korea’s focus on fast-growing fields such as AI- and software-based devices, advanced diagnostics, and robotic surgery systems.

Clinical Evaluation Moves to the Front

The most significant change is how clinical evaluation is positioned.

Clinical assessment is no longer a post-approval step. Instead, it is now evaluated in parallel with safety and efficacy during MFDS approval. If the CER demonstrates internationally acceptable safety and effectiveness:

• The technology can be used immediately in clinical practice
• No separate “conditional new medical technology” designation is required

After three years of clinical use, the technology undergoes the formal nHTA and becomes eligible for review for national health insurance coverage.

From initial clinical use until reimbursement status is determined (estimated six to seven years), the technology may be billed as non-reimbursed.

New CER Guidelines Emphasize Clinician Involvement

MFDS also released a revised Guideline for Preparing Clinical Evaluation Reports (CERs), applicable to approval applications submitted from January 27, 2026.

While aligned with international standards such as IMDRF, the guideline more clearly reflects domestic review practices. Notably:

• CER review and final approval are limited to individuals with relevant clinical expertise
• Therefore, Involvement of clinician in the applicable specialty is no longer optional in CER development.

What This Means for Manufacturers

Both global and domestic manufacturers will feel the impact.

CERs prepared mainly by regulatory experts—without documented clinician review of clinical conclusions—are more likely to face requests for additional data or review delays. This risk is especially high for digital medical devices and medical robots, where clinical context is critical.

Manufacturers should plan clinician participation from the earliest stages of CER development.

How MDREX Can Help

MDREX views this change not just as faster procedures, but as a structural shift that fully integrates:

• Clinical data generation
• Regulatory approval
• Market entry strategy

MDREX will continue to support clients through comprehensive consulting services including:

• CER strategy development aligned with the Immediate Market Entry program
• Clinician-participatory CER development
• MFDS approval support
• Downstream nHTA and national health insurance entry strategies

For further inquiries, please contact MDREX at pro@mdrex.co.kr.