Medical Device Compliance Deadline Calendar
Every dated regulatory deadline, labeling/UDI transition, and recurring renewal window documented on our country pages, organized by date instead of by country — built for teams planning label translation, UDI submission, and multi-market compliance against a real clock.
Why deadlines deserve their own view
The labeling requirements hub on this site answers "what does each country require" as a country-by-country matrix. This page answers a different question: "what changes, and when." Labeling and UDI transitions are a particular kind of risk — they are usually late-stage blockers, not early-stage ones. A registration number, local-holder identity, or approval date often has to be confirmed before the final label and Instructions for Use content can be locked, which means translation, print production, and UDI database submission compete directly with the last weeks before a compliance date, not an earlier planning phase. Professional medical-device-experienced local-language translation commonly needs 6-8 weeks of lead time on its own — before print production, database entry, or inventory transition are even factored in. Every row below states the date exactly as documented on the corresponding country page, together with that page's own verification date, so a stale or superseded figure here is traceable back to its source rather than presented as a standalone fact. Rows where the exact date, scope, or continued validity could not be independently confirmed are explicitly flagged (待核验) rather than smoothed over — treat those as watch items, not committed dates.
Compliance calendar, by date
Next 6 months
2Dated from this module's last verification pass (2026-08-17) through roughly February 2027. If translation, UDI data, or label artwork is not already in motion for these, it is late.
| Date | Country | What becomes mandatory | Who is affected | Preparation lead-time note |
|---|---|---|---|---|
| 18 October 2026 | Indonesia | Halal certification becomes mandatory for Class A risk medical devices (BPJPH-confirmed; BPJPH has publicly stated there will be no extension). | Class A medical devices that contain or come into contact with animal-derived materials or other Halal-relevant substances. | The Indonesia country page does not state a fixed Halal certification-process lead time — confirm the LPH (e.g., LPPOM MUI) audit and certification timeline directly with BPJPH/LPPOM MUI; do not assume the 6-8 week label-translation lead time applies here. Consequences of missing this date can reportedly include removal from shelves and customs holds. |
| 1 November 2026 | Singapore | UDI becomes mandatory for all Class C general medical devices and IVDs (GN-36-R2 Phase 2), registered under SMDR/SIDREG. | Any Class C device or IVD entering, or already in, the Singapore registration pipeline. | HSA guidance treats this as an immediate-planning deadline for any Class C device being registered now — no stated post-deadline grace window. Build UDI compliance into the submission plan from the outset rather than as a later-stage task. |
6-18 months out
4Roughly March 2027 through February 2028. Far enough out to plan a translation/dossier budget around, close enough that Notified Body and database queues should already be a live concern.
| Date | Country | What becomes mandatory | Who is affected | Preparation lead-time note |
|---|---|---|---|---|
| ~May 2027 (360 calendar days after the 19 May 2026 DOF publication) | Mexico | NOM-137-SSA1-2025 (the new IMDRF-aligned labeling standard) enters into force, replacing the 17-year-old NOM-137-SSA1-2008. A further 180-calendar-day sell-through allowance applies to stock already labeled under the 2008 standard, extending the practical cutover to roughly November 2027. | Every medical device label, package insert, and IFU sold in Mexico. | This is a structural label redesign to a new required-element set aligned to IMDRF guidance, not a simple re-translation of the existing 2008-format label — budget dossier and print-production time accordingly ahead of the ~May 2027 effective date, not just translation time. |
| 1 June 2027 | China | UDI becomes mandatory for Class I IVD reagents, and full UDI coverage takes effect for all Class II devices. | Class I IVD reagent products, and every Class II device not already brought into UDI scope under the earlier phased rollout. | UDI data must be uploaded to the national database before market launch and included in every registration, filing, renewal, and change submission going forward — missing UDI data is now a review-blocking defect, not a minor omission. |
| July 2027 (mandatory enforcement date) | Malaysia | The new ePermit (DagangNet) import-permit layer becomes mandatory, after a voluntary submission window that opened in June 2026. | Importers and Authorised Representatives handling medical device import into Malaysia. | Track ePermit alongside, not instead of, standard MDA product registration. The voluntary window already open since June 2026 gives a runway to test the system before mandatory enforcement — manufacturers not yet enrolled should treat that runway as already running, not as unused buffer. |
| 31 December 2027 | EU | The MDR transition deadline for legacy-MDD Class III and Class IIb implantable devices: an MDR CE certificate must be obtained by this date. | Devices still operating on a legacy MDD/AIMDD CE certificate that fall into Class III or Class IIb implantable. | Notified Body capacity is under severe pressure and MDD-transition review backlogs are significant, per the EU country page's own strong recommendation: do not wait until close to this deadline to initiate MDR migration — lock in NB scheduling as early as possible. |
Further out (2028 and beyond)
8These deadlines are real and dated on their source country pages, but far enough out that they belong in a multi-year roadmap rather than a current sprint — several (marked 待核验) are confirmed only at the year level.
| Date | Country | What becomes mandatory | Who is affected | Preparation lead-time note |
|---|---|---|---|---|
| ~June 2028 | Thailand | The sell-through allowance ends for devices still using pre-2026 (2020-rule) labeling; full B.E. 2568 label content — including the new SaMD UDI requirement for Class 2-4 software — becomes the only compliant format. | Hardware and software (SaMD) device labels still on the legacy 2020 format. | The Thailand country page's own recommendation: plan label/IFU updates now rather than at renewal, particularly for Class 2-4 software products that need UDI-ready labeling built in. |
| 1 November 2028 | Singapore | UDI becomes mandatory for all Class B general medical devices and IVDs (GN-36-R2 Phase 3). Class A remains voluntary. | Class B devices and IVDs. | Same submission-plan discipline as the 2026 Class C milestone above — treat as a launch-blocking item for any Class B device entering the pipeline as this date approaches. |
| 31 December 2028 | EU | The MDR transition deadline for legacy-MDD Class IIb (non-implantable) and Class IIa devices: an MDR CE certificate must be obtained by this date. | Devices still on a legacy MDD CE certificate that fall into Class IIb non-implantable or Class IIa. | Same Notified Body capacity-constraint warning as the 2027-12-31 implantable-device deadline above — NB backlog is expected to continue worsening as this later deadline approaches, not ease. |
| 2029 (year only)Contains a flagged, unverified detail | Indonesia | Halal certification becomes mandatory for Class B risk medical devices, per PP No. 42/2024's staggered class-by-class schedule. | Class B devices with animal-derived or other Halal-relevant components. | Only the year is independently confirmed on the Indonesia country page (two secondary sources cite this year; the exact date is not found in accessible official text) — treat as directional and re-verify against BPJPH as the date approaches. |
| 1 June 2029 | China | UDI becomes mandatory for all Class I medical devices — the final wave of China's phased UDI rollout. | All Class I devices not already covered by an earlier UDI phase. | Terminal deadline for any remaining unregistered Class I SKU — the same review-blocking consequence described for the 2027-06-01 milestone above applies here. |
| 30 June 2030 | UK | The CE-marking transitional acceptance period for the Great Britain market is currently set to end; UKCA becomes the mandatory long-term marking (unless MHRA extends the transition again, as it has done historically). | All devices relying on CE marking (rather than UKCA) to access the England/Wales/Scotland market. Northern Ireland is unaffected — it runs on EU MDR/UKNI under the Windsor Framework. | The UK country page explicitly recommends initiating UKCA migration planning 3 years in advance of this deadline — treat that recommendation as the start of the runway, not this date. The deadline has been extended multiple times historically, so monitor MHRA announcements, but do not plan around an extension happening again. |
| 2034 (year only)Contains a flagged, unverified detail | Indonesia | Halal certification becomes mandatory for Class C risk medical devices, per PP No. 42/2024's staggered schedule. | Class C devices with animal-derived or other Halal-relevant components. | Same year-only confirmation caveat as the 2029 Class B row above — re-verify against BPJPH well before treating this as a firm planning date. |
| 2039 (year only)Contains a flagged, unverified detail | Indonesia | Halal certification becomes mandatory for Class D risk medical devices and biological products — the final wave of Indonesia's Halal rollout. | Class D devices and biological products with animal-derived or other Halal-relevant components. | Same year-only confirmation caveat as the 2029 and 2034 rows above. |
Pending — not yet dated
6Real, active regulatory changes that a European labeling team should watch, but that do not yet carry a confirmed date, scope, or continued-validity status on the source country page. Do not build a filing strategy or budget around any row in this band.
| Date | Country | What becomes mandatory | Who is affected | Preparation lead-time note |
|---|---|---|---|---|
| Not yet in force — draft stageContains a flagged, unverified detail | Colombia | A draft unified decree (Régimen Sanitario de Dispositivos Médicos) would replace both Decreto 4725/2005 and Decreto 3770/2004 with a single three-tier authorization model, and explicitly proposes a foreign-reference-authority reliance mechanism. | Any manufacturer or Titular currently planning on Decreto 4725/2005's current framework — the draft would eventually restructure how registration classes and reliance work. | The draft cleared its WTO public-comment deadline on 17 July 2026 but has not been presidentially sanctioned or published, and it proposes an 18-month transition period after eventual publication. Decreto 4725/2005 and Decreto 3770/2004 remain the operative law as of this page's verification date — track this as a planning input for a 2027+ strategy, not a live filing basis. |
| Not itemized — phased, category by categoryContains a flagged, unverified detail | Taiwan | Class II devices are being brought into UDI scope on a phased, category-by-category basis (the legal basis took effect 1 May 2021 and Class III was brought into scope from that date), but the exact per-category Class II deadlines are not itemized on the country page. | Class II device categories awaiting their specific UDI phase-in date. | Confirm current UDI-phase scope for the specific product category directly against TFDA's UDI section (via TUDID) before finalizing label artwork — the country page explicitly flags this as unconfirmed at the category level. |
| Not confirmed on this passContains a flagged, unverified detail | Taiwan | TFDA's registration-section navigation references a "flexible validity permit zone," but this round's research could not confirm specific transition dates or applicability detail for it. | Unconfirmed — do not assume applicability to a specific product without direct TFDA confirmation. | Flagged as a watch item only. Confirm directly with TFDA before planning around this mechanism, and note the country page separately confirms no universal default grace period exists for relabeling existing stock when a labeling or UDI rule changes — transition guidance is issued per specific regulatory change. |
| Roughly 2025-2028 (pace unconfirmed)Contains a flagged, unverified detail | Argentina | ANMAT has published a UDI roadmap referencing IMDRF guidance; Clase III/IV devices have begun phased UDI first, with Clase II expected to phase in over this window. | Clase II devices awaiting their UDI phase-in. | Pace unconfirmed given the broader 2025-2026 Argentine regulatory reform wave (Disposición 64/2025, Decreto 892/25, and related instruments) — re-verify against ANMAT's current roadmap before budgeting a Clase II UDI project. |
| Pilot ended 30 April 2026 — post-pilot status unconfirmedContains a flagged, unverified detail | Malaysia / Thailand | A bidirectional Malaysia-Thailand reliance pilot ran 1 February - 30 April 2026, cutting MDA's reliance-based review from 60 to 30 working days for Thai-approved devices, and Thai FDA's reliance-based review from 150 to 120 calendar days for MDA-approved devices. | Class B/C/D devices previously approved by the counterpart authority (MDA or Thai FDA) that would have relied on this pilot's faster track. | Neither the Malaysia nor the Thailand country page could confirm whether this pilot has been extended or made permanent policy after its 30 April 2026 end date — confirm the live status directly with MDA or TFDA before relying on the pilot's faster timelines for a live filing. |
| Suspended through at least mid-May 2026 — status beyond that unconfirmedContains a flagged, unverified detail | Philippines | AO No. 2024-0016's steep new FDA fee schedule remains suspended (it was suspended in June 2025 and extended twice more); the legacy fee schedule under decades-old AO No. 50 s.2001 remains in force in the meantime. | Any manufacturer budgeting a Philippine CMDN/CMDR filing. | A project spanning the mid-May 2026 boundary should budget contingency for a fee jump — confirm the live fee status directly with CDRRHR before finalizing a Philippines filing budget. |
Recurring-obligation reminders
Renewal windows and continuing obligations, not one-off deadlines — miss one of these and the consequence is often a suspended registration, not just a late filing.
| Country | Obligation | Window | Note |
|---|---|---|---|
| Thailand | Listing, Notification, and License certificate renewal (5-year validity) | Renewal window opens 1 October and closes 31 December of the expiry year. | A fixed annual calendar window, not a rolling "before expiry" rule — mark it on a recurring compliance calendar per certificate, not just per product launch. |
| Saudi Arabia | MDMA (Medical Device Marketing Authorization) renewal (5-year validity) | Renewal application must be submitted at least 6 months before expiry. | If filed on time, the original MDMA remains valid until the new one is issued — but renewal requires an updated ISO 13485 certificate, updated Free Sale Certificate, a post-market safety summary, and updated Arabic labeling where revised, none of which should be assembled in the final 6-month window. |
| United States | FDA establishment registration renewal (annual) | Renewal window opens 1 October and closes 31 December each year. | Annual, not multi-year — a fixed fee applies each cycle (USD 11,423 for FY2026); FDA may grant a hardship waiver for certain qualified small businesses for annual renewal, but not for initial registration. |
| India | MD-15 import licence retention-fee payment | Every 5 years, for as long as the licence remains on the market. | The licence itself carries no fixed expiry and remains valid "in perpetuity," but this is the Authorised Agent's continuing responsibility, not a passive CDSCO reminder system — missing this deadline suspends the import licence and the ability to bring further shipments into India. |
| Colombia | Registro Sanitario renewal filing | Must be filed at least 3 months (90 calendar days) before expiry. | Renewal filed outside this window is treated as a new application, not a renewal — missing the filing deadline restarts the clock and the cost, so this is not a minor administrative slip. |
Working-backward lead-time planning
Sequence dossier, translation, and Notified Body work against these documented lead times, not against the compliance date itself.
Stated on the labeling requirements topic and echoed on the Indonesia country page — this is the single most common lead-time figure across the country pages that quantify it at all.
The India country page notes this step is now mandatory in practice, not optional, since the 23 October 2025 CDSCO directive requiring CLA (not State Licensing Authorities) to classify Class A, Class B, and IVD devices first.
The UK country page's own explicit recommendation, given the deadline's history of repeated extensions and the risk of over-relying on another extension.
The EU country page states NB capacity is under severe pressure and MDD-transition review backlogs are significant, with a strong recommendation not to wait until close to the deadline.
Per the March 2026 Third Edition guidance — plan full product registration to land within this window if long-term market presence, not just a one-time import, is the goal.
Flagged rather than estimated, in keeping with this page's fact discipline: confirm directly with BPJPH/LPPOM MUI well ahead of the 18 October 2026 Class A deadline.
Go deeper on requirements or countries
This calendar is a planning cross-reference, not a substitute for the full country-by-country requirement set.
This calendar is a planning cross-reference built from the same country pages as the labeling requirements hub — use the hub for the full country-by-country requirement set, and use this page to sequence work against the clock. Every country name links to the full country regulatory report for registration pathway, timeline, cost, and post-market detail.