Global Regulatory Intelligence Review

Canada brings MDEL Phase 2 forward to 1 December

Canada · MD + IVD · Correction / Upcoming · Action required

Health Canada has corrected the date on which Phase 2 of its medical device establishment licence (MDEL) changes takes effect: the amendments come into force on 1 December 2026, not 14 December as its June bulletin said (Health Canada bulletin). The regulations come into force 180 days after their 4 June registration (Canada Gazette, SOR/2026-110). Our 26 October edition gave the earlier date.

From 1 December the MDEL application (FRM-0292) moves online, with reordered sections and an acknowledgement in place of the senior-official signature; the current PDF form stays in use until then. A new edition of guidance GUI-0016 takes effect the same day, replacing version 10 (GUI-0016). Importers and distributors should have their documented procedures and supplier lists ready four weeks from now.

UK: MHRA registration fees due 6 November

UK · MD + IVD · Upcoming · Action required

The MHRA has recalculated 2026/27 annual fees so that registrations for devices that are only put into service are excluded, with revised amounts shown in DORS. Outstanding fees for devices placed on the market must be paid by 6 November 2026, and accounts with unpaid fees after that date will be suspended (GOV.UK).

The annual fee is £300 per Level 2 GMDN category (or Level 1 where no Level 2 exists) for 1 April 2026 to 31 March 2027. Manufacturers and UK Responsible Persons should check their DORS balance this week.

Japan: PMDA device web application platform offline

Japan · MD + IVD · New · Review

PMDA has suspended its Medical Device Web Application Platform after unauthorized access between 23 and 26 October. It says no leakage or tampering has been found so far and has not set a restart date (PMDA). New approval applications and notifications should go through MHLW's FD application software (FD申請); PMDA will announce how to replace documents in pending files. Companies with Japanese submissions under way should plan for delays.

South Korea proposes WHO prequalification route for IVD clinical data

South Korea · IVD · Proposed · Review

MFDS has published a draft amendment to its IVD approval, notification and review regulation (Notice 2026-508, 28 October) (MFDS). Clinical performance data accepted during WHO prequalification, or confirmed as part of a prequalification listing decision, would count as supporting data for Korean approval, which is aimed at avoiding repeat studies for tests of diseases not endemic in Korea.

If an application is rejected only because the clinical performance data were inadequate, a re-application would be reviewed only for the supplemented data. The draft also lets Class 1 IVD instruments leave raw materials off notifications and extends the temporary distributor-notification exemption to diagnostic reagents used in public-health crises. Comments are due by 16 November; no effective date is given.

China issues blaKPC resistance-gene test guideline

China · IVD · New · Review

CMDE Notice 2026 No. 30 issues the registration review guideline for carbapenem-resistance gene blaKPC detection reagents, finalising the draft consulted on in October 2025 (CMDE sub-centre). Manufacturers of molecular antimicrobial-resistance assays planning China registration should work from this text.

EU moves the SSCP/SSP upload deadline to 27 March 2027

EU · MD + IVD · Revised · Review

A revision of MDCG 2026-4 says manufacturers will be able to upload SSCPs and SSPs in EUDAMED from December 2026, instead of October. For devices placed on the market before EUDAMED became mandatory, the upload target moves from 27 February to 27 March 2027, and until then notified bodies upload only the master version (Commission news; MDCG 2026-4). For IVDs, this covers the SSPs required for Class C and D devices.

US publishes four new De Novo classifications

US · MD / SaMD · New · Review

FDA classification orders published on 30 October create new device types for software-aided skin-lesion assessment (21 CFR 878.1830), radiology software that refers fibrotic lung findings on CT (21 CFR 892.2085), spinal imaging for neuraxial procedures (21 CFR 868.1985) and an over-the-counter device to assess sleep-apnea risk (21 CFR 868.2378). Developers of similar software can now use these as predicates and should review the special controls. None of them are IVDs.

China adds clinical-trial review points

China · MD · New · Informational

CMDE has issued clinical-trial review points for implantable brain-computer interface systems that restore hand motor function (No. 29), boron neutron capture therapy systems (No. 32) and transcatheter tricuspid replacement and repair systems (No. 33) (CMDE sub-centre list).

FDA proposes mandatory eSTAR for IDE applications

US · MD + IVD · Proposed · Review

A draft guidance published on 28 October would require IDE applications to be submitted with the eSTAR template, starting at least one year after the guidance is finalised, and FDA does not plan to grant waivers (Federal Register; FDA). Comments are due by 28 December. Comments on the related PMA eSTAR draft close on 17 November (Federal Register).

FDA revises its drug delivery performance draft

US · MD · Proposed · Review

FDA has reissued, as a revised draft, its guidance on essential drug delivery performance characteristics for devices that deliver drugs and biologics. It replaces the 2024 draft and uses QMSR terminology (Federal Register). Comments are due by 28 January 2027. It does not apply to IVDs.

EU MDR/IVDR revision and companion-diagnostic SSPs

EU · MD + IVD · Proposed · Informational

The European Parliament has published SANT committee amendments 374–615 on the MDR/IVDR targeted revision (EUR-Lex); the committee vote is set for 3 December and the indicative plenary date is 14 December (OEIL). Current requirements are unchanged. EMA's COMBO group has endorsed a revised SSP template for companion diagnostics for MDCG to consider (EMA).

Brazil: enforcement and open consultations

Brazil · MD · New / Proposed · Informational

ANVISA ordered prohibitions and recalls of several devices on 23 October (ANVISA). Public consultations CP 1.420–1.423/2026 accept contributions until 28 January 2027 (AnvisaLegis), and the MDSAP directed consultation closes on 9 November.