How medicines and medical devices get approved in South Korea

Companies that make or import a new drug apply to the MFDS for an item permit for each product. The agency reviews quality, nonclinical and clinical data, a risk management plan and GMP evidence.

Full application, new active substance · target 70 days · verified October 3, 2026

Drugs that are not new drugs but still need a safety and efficacy review use this route. Examples are new combinations, new routes of administration, new indications and new salts. The MFDS reviews the selected data that apply to the change.

Full or mixed application, known active substance · target 70 days · verified October 3, 2026

A developer can ask the MFDS to designate a medicine in development for priority review. The agency decides within 30 days. Designated products are reviewed ahead of others, within 90 days unless there are special circumstances. The agency runs this program under the name GIFT and also offers rolling review and close contact with reviewers.

Priority or accelerated review · target 90 days · verified October 3, 2026

For serious diseases and rare diseases, the MFDS can grant an item permit based on a clinical endpoint or a surrogate endpoint that reasonably predicts clinical benefit. The holder must submit confirmatory trial data within a set period. The agency first hears the Central Pharmaceutical Affairs Council.

Conditional or accelerated approval · verified October 3, 2026

The MFDS designates orphan drugs for rare diseases, or for rare uses where there is no alternative or the product is clearly safer or more effective. Rare use means 20,000 or fewer patients in Korea. Products still in development can get a development-stage designation. Orphan drugs get 10 years of clinical data protection after approval.

Orphan or rare disease designation · verified October 3, 2026

Biological products, recombinant products, cell-culture products and vaccines get an item permit from the MFDS under the biologics regulation. The review covers quality, nonclinical and clinical data and biologics GMP. Vaccines and other biologics also need national lot release for each lot before sale.

Full application, new active substance · target 115 days · verified October 3, 2026

A biosimilar must show comparability with a biologic already licensed in Korea in quality, nonclinical and clinical terms. The rules call for a pharmacokinetic study and a confirmatory clinical trial, but the confirmatory trial can be skipped when quality, nonclinical and pharmacokinetic comparability is shown.

Biosimilar application · target 115 days · verified October 3, 2026

A generic has the same active ingredient, strength, route, indication and dosage as a new drug or another listed reference drug. The applicant files quality data, bioequivalence data and patent documents. Regional MFDS offices issue the permit.

Generic application · target 55 days · verified October 3, 2026

Products listed in the Korean Pharmacopoeia or a recognized compendium, or made to a published standard manufacturing formula, can be notified to a regional MFDS office instead of getting a full permit. Many over-the-counter products use this route. Korea has no separate OTC approval route: the MFDS classifies each product as prescription or over-the-counter during the permit or notification.

Non-prescription monograph · target 10 days · verified October 3, 2026

After the product permit, each lot of a vaccine or other designated biologic needs national lot release before sale. The MFDS reviews the manufacturing and quality records for the lot and tests samples, then issues a lot release certificate.

Other route · verified October 3, 2026

Cell therapies, gene therapies, tissue-engineered products and advanced combined products get an item permit from the MFDS under the Advanced Regenerative Bio Act. The applicant files safety and efficacy data, GMP and test method data, GMP evaluation data and a risk management plan. Some products need long-term follow-up of treated patients.

Full application, new active substance · target 70 days · verified October 3, 2026

Developers of cell and gene therapies can ask the MFDS for fast-track designation. The agency decides within 60 days. Designated products can get customized review of data filed in stages during development, priority review of the permit application, and a conditional permit based on early evidence.

Priority or accelerated review · verified October 3, 2026

Korea has no separate combination product route. A drug-device combination follows the main function. If the main function is the device, a device permit covers the whole product. If the main function is the drug, the drug permit covers the device part. Drugs combined with digital medical devices can be licensed as digital convergence drugs.

Other route · verified October 3, 2026

Most Class 1 medical devices, the lowest-risk group, only need a product notification. The notification goes to the national medical device safety information institute, which the MFDS has entrusted with this work.

Device: premarket notification · target 5 days · verified October 3, 2026

Many Class 2 devices that are substantially equivalent to devices already on the Korean market are certified by the national medical device safety information institute rather than approved by the MFDS. The technical documents are reviewed first, and the certification itself has a 5-day processing period.

Device: conformity assessment by a certification body · target 5 days · verified October 3, 2026

Class 3 and Class 4 devices, and Class 2 devices that are not equivalent to devices already permitted, need a product permit from the MFDS. The agency reviews technical documents and, where needed, clinical data. Fully new devices pay a much higher fee and can be put under a post-market study for 4 to 7 years.

Device: premarket approval by the regulator · target 80 days · verified October 3, 2026

The MFDS can designate high-tech devices that clearly improve safety or effectiveness over existing devices or treatments as innovative medical devices. Designated devices can get staged review during development and priority review of the permit application.

Device: breakthrough or priority program · verified October 3, 2026

In vitro diagnostic devices have their own law. Class 3 and 4 IVDs, and Class 2 IVDs that are not equivalent to permitted ones, need a permit from the MFDS. The review covers technical documents and, where needed, clinical performance data. A companion diagnostic can be reviewed together with its medicine.

Device: premarket approval by the regulator · target 80 days · verified October 3, 2026

Class 2 IVDs that the MFDS lists for certification and that are equivalent to permitted products are certified instead of permitted. The certification form lists a 5-day processing period.

Device: conformity assessment by a certification body · target 5 days · verified October 3, 2026

Class 1 IVDs, the lowest-risk group, are notified. The notification form lists a 5-day processing period.

Device: premarket notification · target 5 days · verified October 3, 2026

Since 2025, software as a medical device and other devices that use digital technology such as AI fall under the Digital Medical Products Act. Class 3 and 4 products, and products not yet classified, need an MFDS permit. Most Class 2 products are certified. The forms list 80 working days when clinical evaluation data, a change control plan or professional-use software data are reviewed.

Device: premarket approval by the regulator · target 80 days · verified October 3, 2026

Class 1 digital medical devices, including low-risk software, are notified to a certification agency designated by the MFDS. The form lists a 5-day processing period.

Device: premarket notification · target 5 days · verified October 3, 2026