Timeline and Budget Planning for Korean Medical Device Registration

1. Key takeaways

Korean project scheduling must be built on the statutory review periods as the baseline, with three further segments stacked on top: dossier preparation, KGMP audit and deficiency responses. The statutory figures are a floor, not the total project period. The statutory review periods are: 5 working days for Class 1; 25 working days initially and 15 working days for changes for Class 2; 55 working days without clinical data and 70 working days with clinical data for Class 3 and Class 4.

• Two further statutory figures apply: the KGMP certificate is valid for 3 years with the periodic audit application due 90 days before expiry, and item renewal occurs every 5 years.
• Every other figure, including licence holder establishment and annual fees, translation and consultancy costs, dossier preparation duration, deficiency rounds and overseas audit arrangements, has no statutory source and must be treated as a practical estimate, never mixed into the same column as statutory figures.
• The statutory period excludes deficiency response time, which is the largest single source of schedule distortion and must be modelled explicitly.

2. Legal basis

The statutory periods, fees and renewal rules rest on the following instruments, traceable through the regulation names, document numbers, publication dates and provisions listed below.

Timeline and budget planning table (by class, statutory figures and practical estimates in separate columns)

3. Expert insights

Insight 1: Statutory figures and practical estimates must stay in separate columns; mixing them destroys the planning table’s verification value. GRZAN fixes two columns in every planning table, one for statutory figures and one for practical estimates. The former traces to the Enforcement Rule attached table, Article 49 of the Medical Devices Act or KGMP Public Notice No. 2023-79; the latter comes from project experience and quotations and varies with the product and the entity. Kept apart, the statutory column can be used directly for external commitments and the practical column for internal planning, without contaminating each other.

Insight 2: The statutory period excludes deficiency time, which is the largest source of planning distortion. The figure of 55 working days is roughly 11 weeks in calendar terms, and it covers only the review period after acceptance. Once the reviewing body issues a deficiency request, the period is usually recalculated or suspended as stated in the deficiency notice of the accepting body. GRZAN models the schedule as the statutory period plus at least an equally long allowance for dossier work and deficiency responses, rather than committing to a certificate date based on the statutory period alone.

Insight 3: The three long-term timelines are mutually independent and must be merged into one calendar. The item renewal at 5 years, the KGMP certificate at 3 years with the periodic audit application due 90 days before expiry, and UDI data maintenance with modifications within 10 days of a change have different start points and cycles. Managing by product causes misses; managing by certificate causes duplicates. GRZAN builds the calendar on the principle of one product, one licence, one expiry date, merging the three lines onto a single sheet for tracking.

Insight 4: Item renewal has a precondition; expiry alone does not make renewal possible. Article 49 of the Medical Devices Act provides that renewal may be applied for only for devices actually manufactured or imported during the current validity period, and renewal is refused where the application is not filed on time or serious safety or effectiveness problems exist. In practice the renewal application must be submitted 180 days before the end of the 5-year term (practical estimate / lower-level rule). This means a product with no actual shipments over a long period may be unable to complete renewal even while its licence remains valid.

4. Practical recommendations

• Fix two columns in the planning table, one for statutory figures and one for practical estimates. The statutory part traces to specific provisions; the practical part states its source; mixing is prohibited.
• Model the schedule as the statutory period plus at least an equally long allowance for dossier work and deficiency responses. Never treat the statutory review period as the total project period.
• Reserve a 180-day lead time for item renewal. Submit the renewal application 180 days before the end of the 5-year term (practical estimate / lower-level rule).
• Confirm renewal eligibility: actual manufacturing or import records must exist within the validity period. For products with no shipments over a long period, assess renewal feasibility early.
• Merge the three long-term timelines into one compliance calendar. Item renewal at 5 years, KGMP at 3 years with the periodic audit application due 90 days before expiry, and UDI modifications within 10 days of a change are tracked uniformly.

5. Verification checklist

• □ Class determination: check against Attached Table 1 of the Enforcement Rule; the class conclusion is traceable.
• □ Statutory review period: check the Enforcement Rule attached table by class; the working-day basis is used and is not mixed with calendar days.
• □ Official fees: check the attached table by class and by clinical data requirement; consistent with the statutory amounts.
• □ Column separation: check whether the planning table sets separate statutory and practical estimate columns; no mixing, and every practical item is marked with its basis.
• □ Deficiency time allowance: check whether the schedule model includes deficiency time; the statutory period was not treated as the total period.
• □ KGMP timeline: check the certificate validity and the periodic audit application timing; valid for 3 years, application due 90 days before expiry.
• □ Item renewal eligibility: check for actual manufacturing or import records within the validity period; records exist and a 180-day lead time is reserved (practical estimate / lower-level rule).
• □ Regulatory information verified as of 29 October 2026 (pending verification for any later amendments).

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 coordinates licence holder arrangements, import business registration, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com