Global Regulatory Intelligence Review

UK confirms indefinite recognition of CE-marked devices

UK · MD + IVD · New policy · Review

On 21 October the UK government confirmed it will legislate so that devices and IVDs CE-marked under the EU MDR and IVDR can be placed on the Great Britain market with no end date (GOV.UK press release; government response). Recognition will cover all MDR/IVDR devices, including those classified higher in GB than in the EU; the proposed separate reliance route for those devices was dropped "to prevent unnecessary regulatory complexity".

Older MDD-certified devices will be accepted until the end of the EU transition period, currently 31 December 2028, instead of the current GB cut-off of 30 June 2028. The response does not address AIMDD or IVDD devices, which stay on their existing deadlines of 30 June 2028 and 30 June 2030 respectively, or earlier certificate expiry (GOV.UK timelines).

Domestic obligations stay in place: non-UK manufacturers still need a UK Responsible Person, devices must be registered with the MHRA, GB post-market surveillance rules apply, and technical documentation must be available in English. Nothing changes in law yet; the government says the amendments will be made, subject to Parliament, before 30 June 2028. UKCA remains available, and Northern Ireland continues under EU rules.

Brazil asks industry about wider use of MDSAP

Brazil · MD + IVD · Proposed · Review

ANVISA has opened a directed consultation to inform a Regulatory Impact Analysis on expanding use of the Medical Device Single Audit Program in Brazil (ANVISA). A proposal presented at the end of 2025 envisaged making MDSAP participation mandatory for device manufacturers, and ANVISA says it is gathering evidence before choosing a regulatory option.

Manufacturers and industry associations, whether or not they already use MDSAP, are asked about their experience, barriers to joining, costs and the expected impact of expansion. Responses go through ANVISA's online form by 9 November.

Brazil publishes its first lists of recognized standards

Brazil · MD · New · Review

ANVISA has published lists of recognized technical standards for medical devices: a cross-cutting list (v1.0), orthopedic implantable materials (v1.1) and materials for health use (v0.0) (ANVISA news; list page). The standards support demonstration of the safety and performance requirements in RDC 848/2024.

Use is voluntary unless a regulation says otherwise. Conformity with a recognized standard can reduce the need for further technical justification, provided the standard applies and objective evidence is supplied, and alternative methods remain acceptable with scientific justification. A newer edition of a listed standard may be used before ANVISA updates its list. None of the three lists is IVD-specific; ANVISA says categories will be added over time.

China revises HER2 FISH and HCV genotyping review guidelines

China · IVD · Revised · Review

CMDE Notice 2026 No. 28 (13 October) issues 2026 revisions of the registration review guidelines for HER2 gene amplification detection reagents (FISH) and HCV genotyping detection reagents (CMDE sub-centre release list; CAIVD). CMDE says the revisions strengthen guidance for IVD registration submissions and technical review.

Both replace guidelines issued under CFDA Notice 2017 No. 209 (NMPA guideline list). Manufacturers preparing China registrations for these assays should work from the 2026 texts.

Japan sets rules for IVD performance re-evaluation

Japan · IVD (with device provisions) · New · Review

MHLW Ordinance No. 142 of 2026, promulgated 30 September, implements the amended PMD Act and takes effect 20 May 2027 (MHLW notice via JMHA). For diagnostics, it introduces performance re-evaluation of IVDs modelled on drug re-evaluation: the IVDs in scope will be designated in the Official Gazette, and re-evaluation will cover the performance and quality tied to each approval.

Applications must meet test-facility and data-reliability standards, and holders must submit any data that raises doubts about quality, efficacy or safety. Designated IVDs must also collect performance information and report to MHLW through PMDA, covering shipments, literature findings and measures taken, within two months after each reporting period.

For devices more broadly, registered certification bodies must now give six months' notice, rather than two weeks, before suspending or ending certification work. Conforming amendments are also made to the device QMS and post-marketing study ordinances.

Saudi Arabia opens a reliance pathway for device approvals

Saudi Arabia · MD + IVD · New · Review

SFDA guidance MDS-G30 (v1.0, 9 September) lets manufacturers use an existing approval from a recognized regulator to shorten Medical Device Marketing Authorization review (SFDA guide page; MDS-G30 PDF). The recognized authorities are the TGA, Health Canada, EEA national competent authorities, PMDA, MHRA and US FDA, and SFDA may add other IMDRF members later.

The device must be identical to the approved one in design, manufacturing process and intended use, and must meet Saudi-specific requirements such as electrical standards, labeling language and storage conditions. Excluded routes include self-declaration, approvals based mainly on substantial equivalence to a predicate, custom-made devices and products with significant recalls; SaMD and AI-enabled devices may be excluded.

Applicants upload evidence of the reference approval and a signed Reliance Form with the MDMA application, and MDSAP certificates are accepted as QMS evidence. SFDA targets 35–60 working days for complete applications in all risk classes and may request more data for AI-enabled devices, companion diagnostics and combination products.

Singapore refreshes its registration guidance

Singapore · MD + IVD · Revised · Review

HSA has issued "2026 Oct" revisions of GN-15 (R15, product registration, with annex templates), GN-17 (R5, CSDT for general medical devices), GN-18 (R5, CSDT for IVDs), the premarket submission checklist and the MEDICS e-submission guides (HSA guidance documents). New Singapore submissions should use these versions. HSA's Registration Support Initiative fee waiver for unregistered devices runs to 31 December 2026 (HSA announcement).

Canada updates shortage reporting and licensing rules

Canada · MD + IVD · Revised / Upcoming · Review

Health Canada has issued GUI-0137 v4 on reporting medical device shortages and discontinuations, effective 17 June 2027, and GUI-0147 v2 on exceptional importation (Health Canada bulletin). Separately, Phase 2 of MDEL modernization takes effect 14 December 2026, covering foreign distributors selling through MDEL-holding importers, documented procedures and supplier lists (Health Canada).

Japan issues device notices on e-IFU and contact lenses

Japan · MD · Revised / Clarification · Informational

Between 7 and 16 October MHLW issued notices on nuclear-medicine equipment in approvals and e-IFU, an e-IFU format Q&A, a revised contact lens approval Q&A, dental bone graft evaluation, and re-examination results (Fukuoka Prefecture list of MHLW device notices). Holders of Japanese approvals that use e-IFU should review the Q&A.

EU MDR/IVDR revision heads to committee vote

EU · MD + IVD · Proposed · Review

The European Parliament's SANT committee has scheduled provisional adoption of its draft report on the MDR/IVDR targeted revision (2025/0404(COD)) for 3 December 2026 (SANT document), and the Legislative Observatory lists an indicative plenary date of 14 December (OEIL). The text remains a proposal, and current requirements are unchanged.

China and Brazil open new drafts and consultations

China / Brazil · MD (horizontal) · Proposed · Informational

CMDE has released draft registration review guidelines for cardiac 3D electrophysiology mapping systems and orthokeratology lenses, and finalized Notice 2026 No. 27 on batteries for active implantable devices (CMDE sub-centre list). In Brazil, ANVISA's public consultation CP 1.427/2026 on a regulatory sandbox runs to 11 December (ANVISA).