MFDS has added patient experience data to the priority-review designation framework
MFDS revised its guidance on considerations for applying for priority review designation on August 28, 2026.
The Agency states that the revision allows patient experience data to be used when applying for designation of a priority-review drug.
Patient experience data can describe how patients experience a disease, symptoms, treatment burden, functional impact, risk tolerance, and treatment expectations. Its inclusion can therefore add a patient-centered dimension to the case for why a product warrants accelerated regulatory attention.
The current official scope is pharmaceuticals
The scope boundary is important.
Although the Korean title uses the broader term “medical products,” the current MFDS page classifies the guidance under pharmaceuticals and specifically describes its purpose as allowing patient experience data to be used for applications to designate priority-review drugs.
The available official source does not establish that the same PED consideration has been extended to innovative medical devices, SaMD, or IVDs.
Medical-device teams should therefore avoid treating this revision as a direct change to Korea’s device priority-review pathway unless MFDS later issues device-specific guidance or an explicit cross-product clarification.
The update still matters as a regulatory-direction signal
For medical-device companies, the relevance is currently strategic rather than immediately procedural.
MFDS is explicitly bringing patient experience information into a front-end regulatory decision about accelerated review eligibility. That aligns with the broader international trend toward incorporating patient input into product evaluation and regulatory decision-making.
If Korea later extends a similar framework to innovative medical devices or digital health products, companies that already have structured patient-preference, patient-reported outcome, or disease-burden evidence may be better positioned to use it.
What companies can check
- For pharmaceutical or combination-product programs, assess whether Korean priority-review strategy should now incorporate patient experience data.
- Review whether existing patient research, preference studies, patient-reported outcomes, or disease-burden evidence is structured well enough for regulatory use.
- For medical-device programs, classify this update as regulatory-trend intelligence rather than a direct submission requirement.
- Continue monitoring MFDS for device-specific PED, patient-input, or accelerated-review guidance.
For medical-device teams, the most useful takeaway is the direction of travel. MFDS has formally introduced patient experience data into priority-review designation for drugs; whether that approach expands to medical devices remains a separate question that requires future official support.
Sources
- Primary official source의료제품의 우선심사 지정 신청시 고려사항 (opens in a new tab)Ministry of Food and Drug Safety