Class 2 Item Certification in South Korea: Review Bodies, Timelines and Fees

1. Key takeaways

The default pathway for Class 2 devices is item certification, with technical document review carried out by a review organization designated by the Ministry of Food and Drug Safety. The statutory review period is 25 working days initially and 15 working days for changes, with official fees of KRW 2,400,000 initially and KRW 1,800,000 for changes.

The default pathway has 4 categories of exceptions: products requiring submission of a clinical trial report, digital health related devices such as telemedicine systems, novel devices not defined by the nomenclature and classification rules, and devices combined with drugs. These must be redirected to MFDS for review.

On documentation strategy, a Class 2 device that can demonstrate substantial equivalence to a device already approved, certified, or notified in Korea may have its technical documents correspondingly simplified. Class 2 devices that have already been approved, certified, or notified in Korea 3 or more times may be publicly identified as recognized substantially equivalent devices. GRZAN reduces the success factors of a Class 2 project to two questions: whether the receiving body has been changed by the four exception categories, and whether the six-item equivalence comparison holds up point by point.

2. Legal basis

Certification of Class 2 devices rests on the following instruments.

Review periods and fees for Class 2 devices (per the Enforcement Rule annex)

3. Expert insights

Substantial equivalence is a documentation strategy, not a pathway exemption. Substantial equivalence to a marketed device allows parts of the technical documents to be presented as comparisons, but the certification pathway itself is unchanged, and the KGMP conformity audit cannot be skipped. GRZAN has seen companies read “substantial equivalence is possible” as “certification is not needed”, and stall at the KGMP stage as a result. Substantial equivalence reduces the depth of argumentation; it does not reduce the procedural steps.

The four exception categories must be determined before documentation begins. Products requiring a clinical trial report, digital health related devices, novel devices not defined by the nomenclature and classification rules, and devices combined with drugs must all be redirected to MFDS. The determination decides the receiving body, and with it how the documents are organized and how communication runs. If documents are first compiled to the designated review organization’s standard and the case is only transferred at acceptance, the compilation logic of the earlier investment has to be reworked. GRZAN recommends issuing a written conclusion on each of the four categories during pathway lock.

The gap between 25 working days initially and 15 working days for changes reflects the difference in review scope. Initial certification’s 25 working days covers full technical document review, while change certification’s 15 working days covers only the changed items and their impact scope. The gap tells you that change documentation should stay focused; restating unchanged content wholesale is out of place. GRZAN structures change submissions as change point, impact scope, and argumentation, avoiding a miniature reprint of the initial dossier that would burn the 15 working days advantage on redundant content.

Recognized substantially equivalent device status is an optional public identity, not an automatic grant. Class 2 devices that have already been approved, certified, or notified in Korea 3 or more times may be publicly identified as recognized substantially equivalent devices. The value of the status is that later comparisons can cite it directly and cut duplicated argumentation. GRZAN notes that the threshold is the number of grants, not market performance, so companies do not need to adjust their submission rhythm to obtain it.

4. Practical recommendations

• Judge the four categories first, then fix the body. Issue a written conclusion on each: whether a clinical trial report is required, whether the device is digital health related, whether it is undefined in the nomenclature, and whether it is combined with a drug, then confirm the receiving body.
• Land the equivalence comparison item by item across all six elements. Intended use, mechanism of action, raw materials, performance, test specifications, and instructions for use: each element needs a comparison conclusion and evidence; a missing element means the comparison fails.
• Run KGMP and the technical documents in parallel. The KGMP conformity audit and technical document review are two independent lines; running them in series adds months of waiting beyond the 25 working days.
• Keep change documentation focused. Organize it by change point and avoid wholesale restatement, so it matches the 15 working days change review scope.
• Keep the legal credentials of the comparator device. The comparator must be a device already approved, certified, or notified in Korea; retain its approval, certification, or notification number for verification.

5. Verification checklist

• □ Class confirmation — cross-check against Annex 1 of the Enforcement Rule; standard: clearly Class 2 with no cross-class dispute.
• □ Four-category self-check — compare item by item against clinical trial required, digital health related, nomenclature undefined, and drug combination; standard: a written conclusion for each of the four.
• □ Receiving body — map the self-check result against the designated review organization or MFDS; standard: consistent with the exception determination.
• □ Equivalence comparison — build the comparison table across the six elements; standard: a conclusion for each element with none missing.
• □ Comparator qualification — verify its approval, certification, or notification status in Korea; standard: lawful market authorization obtained and the number traceable.
• □ KGMP status — judged by class with the certificate validity checked; standard: Class 2 requires a valid KGMP certificate, valid for 3 years.
• □ Periods and fees — check the Enforcement Rule annex; standard: 25 working days initially and 15 working days for changes, with fees taken by review type.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team manages MFDS approvals, certifications and notifications, prepares equivalence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com