An annual medical-device regulatory calendar — separate expiry dates from preparation dates

Identify what the calendar manages before entering dates

Changing last year’s spreadsheet heading can mix new products, site changes and completed tasks. First update the products, sites, business information and quality documents maintained in Korea. Separate planned products from existing registrations, and check whether a discontinued product still has post-market work outstanding.

The calendar does not replace regulatory requirements. Permits, certifications, notifications, quality-related recognition, recurring reports and internal activities each need their own basis and dates. Similar document names do not justify copying a common validity period. Reconcile the actual documents and current records as described in the certificate management guide.

Keep expiry, filing and internal start dates in separate fields

The end of a document’s validity, an applicable filing deadline and the date the company starts collecting evidence are different. A single date does not show what must happen before expiry. Confirm applicability and exceptions, and retain the regulatory version and check date used in the calculation.

This is a calendar structure, not a statement that every item applies to every business at the same interval. Verify legal deadlines against primary requirements and the actual product, and set internal start dates according to preparation needs.

Work backwards through document dependencies

Manufacturer requests, samples, testing, report review, translation and application preparation can depend on one another. Testing an unsettled model may create further work after changes. Instead of entering only a final submission date, show what must be available before the next activity can start.

A statutory processing period does not include all of this preparation. Consider manufacturer holidays, actual laboratory availability, access rights and potential requests for additional information. Manage contingency by identifying uncertain tasks and responsible people, rather than adding an unsupported fixed percentage.

Separate recurring dates from event-driven responses

Monthly or quarterly activities can use calendar reminders. Safety information, serious complaints, recall decisions or actual product changes need a separate process when they occur or become known. A scheduled meeting is not a reason to defer initial assessment and necessary action.

For example, the categories in the adverse-event reporting update are not a direction to collect all information at quarter-end. Link intake channels and response owners in the calendar, while tracking awareness dates and reporting decisions in individual case records. Annual planning does not replace immediate-response procedures.

Define completion beyond pressing the submit button

Identify the internal owner, manufacturer contact, reviewer and approver. A backup contact reduces the chance that leave or staff turnover blocks evidence just before a deadline. Work assigned to an external service provider still needs an internal person to track its status.

Separate the filing date from the final outcome, and record requests, responses and the location of the resulting document. Check whether registration information, labeling or internal registers need updating afterwards. Task-specific completion evidence prevents counting a pending application as an approval or continuing to use an obsolete document.

Update changes and uncertain dates at each planned review

Compare actual progress with the plan at the chosen review interval, and incorporate site moves, new models, material changes and discontinuation notices. For published amendments, check effective dates and applicability together. A new year on an official document does not mean every provision applies immediately; transitional arrangements and staged commencement may matter.

Prepare current product lists, regulatory and quality documents, planned changes and open tasks for an annual regulatory calendar review. Clare Partners can help distinguish items needing deadline verification from document preparation. A useful row connects the date’s basis, responsible person, next action and evidence of completion.

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Sources checked: 2026-09-28. The Medical Devices Act version effective 2026-07-01 and MFDS manufacturing and quality management standard, Notice 2026-46. The table and preparation approach are internal management recommendations, not a list of statutory deadlines for individual products.