| Immediate — most of the remaining action window is already goneImmediate | 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. | Verified: 2026-08-17 |
| Immediate — build UDI into every current Class C submission planImmediate | 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. | Verified: 2026-08-17 |
| Immediate — the country page says to plan the structural redesign nowImmediate | ~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. | Verified: 2026-08-17 |
| Immediate — test ePermit during the voluntary runway already in progressImmediate | 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. | Verified: 2026-08-17 |
| Immediate — lock Notified Body scheduling as early as possibleImmediate | 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. | Verified: 2026-08-17 |
| Immediate — plan label/IFU updates now rather than at renewalImmediate | ~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. | Verified: 2026-08-17 |
| By 15 November 2026 for the 8-week edge of translation alone; allow additional print and inventory-cutover time | 10 January 2027Verification flag retained | Brazil | UDI labeling becomes mandatory for Class II devices; this is the labeling track, not the later SIUD data-submission deadline. | Class II medical devices placed on the Brazilian market. | 6–8 weeks for professional local-language translation alone Lock label artwork, UDI carrier placement, translation, and inventory cutover before the deadline. Source: RDC 591/2021 via industry report; pending official review. | Verified: 2026-08-18 |
| Before market launch and before any affected filing; no fixed lead time is stated | 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. | Deadline Calendar → ChinaVerified: 2026-08-17 |
| 30 June 2027 — three years before the current transition deadline | 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. | 3 years 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. | Verified: 2026-08-17 |
