Regulatory update, November 2026: what changed in October

October brought plenty of regulatory news, but for manufacturers selling abroad the work centers on three things: China’s new device GMP took effect on 1 November, EUDAMED registration for devices already on the EU market closes on 28 November, and the US, EU and Australia continue to refine their rules for medical device software. Here are the key points and dates.

At a glance

China: new Good Manufacturing Practice for Medical Devices takes effect and the 2014 version is repealed — 11/1
EU: deadline to register devices already on the market in the EUDAMED UDI/Device module — 11/28
Australia: TGA narrows the exemption for clinical decision support (CDS) software — 11/1
US: FDA expands the Olympus import alert; issues a draft electronic submission template for IDEs (comments by 12/28); adds four new device classifications
UK: government confirms indefinite recognition of CE-marked medical devices and IVDs — 10/21

China NMPA: new device GMP in force from 1 November

The new Good Manufacturing Practice for Medical Devices, issued in NMPA Announcement No. 107 of 2025, has 132 articles and took effect on 1 November 2026, repealing the 2014 version. The accompanying inspection guidelines (NMPA Device Supervision [2026] No. 14) took effect on the same day.

Main changes

Three new chapters: quality assurance; verification and validation; contract manufacturing and outsourced processing
Clearer accountability for the legal representative and senior management; the quality department has a veto over product quality
Contract manufacturing: release of product to market must be done by the registrant itself and can no longer be delegated
Electronic records must be genuine, accurate, complete, timely and traceable; UDI runs through production and release

What it means for exporters: A factory exporting to both the US and Europe needs one quality system that meets China’s new GMP, the US QMSR (in effect since February 2026, incorporating ISO 13485) and EU MDR at the same time. We recommend a gap assessment against the new articles soon, and a review of release responsibilities in contract manufacturing agreements.

EU: EUDAMED registration for devices on the market closes 28 November

The first four EUDAMED modules have been mandatory since 28 May 2026. According to the European Commission’s note on transitional periods, devices placed on the market before mandatory use and still being sold must be registered in the UDI/Device module by 28 November 2026. Certificates issued before mandatory use must be entered by 28 May 2027.

Separately, the targeted MDR/IVDR amendments are still going through the legislative process. Industry reports expect the vote in the European Parliament’s lead committee to slip to early 2027, while the Council aims to agree its position by the end of the year. Until the amendments pass, current MDR/IVDR obligations are unchanged.

SSCP upload moves to manufacturers: deadline 27 March 2027

Under MDCG 2026-4 rev.1, responsibility for uploading the Summary of Safety and Clinical Performance (SSCP) moves from notified bodies to manufacturers (MDR Article 29(4)). Notified bodies will instead confirm the validated version against each Basic UDI-DI. For devices placed on the market before mandatory use, manufacturers must upload by 27 March 2027; the transitional period for notified bodies to upload certificates runs until 27 May 2027.

Note: For products sold in Europe under a distributor’s brand, the UDI-DI must still be assigned by the manufacturer and linked to the manufacturer (MDCG 2026-5). Check the registration status of devices on the market with your EU authorized representative soon.

Note: Manufacturers cannot upload until December 2026, but the notified bodies’ transitional period does not end until May 2027. In between, some devices will be registered with neither a certificate nor an SSCP, so notified bodies will still help with uploads, but only the master version, not translations. Translations are the manufacturer’s responsibility from the start.

Software as a medical device: US, EU and Australia refine their rules

US: FDA’s CDS guidance issued in January 2026 makes clear that software analyzing medical images, IVD signals or physiological signals such as ECG waveforms, and software used for time-critical decisions, remains a medical device. On 20 October FDA published hypothetical case examples for predetermined change control plans (PCCP). The AI-enabled device software lifecycle guidance (draft, January 2025) is on the FY2027 list of guidances to finalize.

Australia: From 1 November, TGA has narrowed the CDS software exemption. Software that makes a diagnosis or treatment decision is no longer exempt, and must show its basis so that clinicians can review it.

EU: Under Rule 11, software providing information used for diagnostic or therapeutic decisions is generally at least Class IIa. The proposed MDR amendments would rewrite this rule, but are still in the legislative process.

Common misconception: “Doctors can see the reasoning, so it isn’t a device.” In the US, any software that analyzes images, IVD signals or physiological signals such as ECG does not qualify as non-device CDS.

US FDA: import alert, IDE electronic template and new classifications

Olympus import alert expanded (10/20): Because of unresolved quality system violations, FDA added more Olympus devices made in Japan to Import Alert 89-04. Quality system problems at a foreign factory can mean products are refused entry.
Draft IDE electronic submission template (10/27): CDRH and CBER issued draft guidance that, once final, will set the electronic format standard and implementation timeline for IDEs. Comments by 28 December (Docket FDA-2026-D-11188).
Four new device classifications (10/29): including software-assisted diagnosis of skin cancer lesions and OTC sleep apnea risk assessment. Similar products can now use these as a basis for a 510(k).

UK: indefinite recognition of CE marking

On 21 October the UK government published its consultation response, confirming that CE-marked medical devices and IVDs will be recognized in Great Britain indefinitely, with UKCA remaining the domestic route. For companies that already hold CE certificates, the route into the UK market is now more certain.

Key dates

Date	Item
11/1	China’s new GMP takes effect; TGA’s narrower CDS exemption takes effect
11/17	Comments close: FDA PMA eSTAR draft guidance
11/24	Comments close: FDA robotically assisted surgical devices (RASD) draft guidance
11/28	EUDAMED registration deadline for devices already on the market
11/30	Comments close: CDRH FY2027 guidance list
12/28	Comments close: FDA IDE electronic submission template draft
12/31	FDA FY2027 annual registration and listing deadline (pay the fee first)

The full member edition also includes

An action checklist with deadlines for each topic
In depth: when software is regulated as a medical device, and whether clinical trials are needed
Monthly case discussion: US and EU market routes for an AI ECG software product
Member Q&A and template library

To learn about membership, email info@medreglo.com or add us on WeChat: RegloMedical.

Sources

NMPA Announcement No. 107 of 2025; NMPA Device Supervision [2026] No. 14
European Commission, EUDAMED transitional periods note; MDCG 2026-5
FDA, Clinical Decision Support Software guidance (2026-01); PCCP hypothetical case examples (2026-10-20)
FDA, Import Alert 89-04 letter to health care providers (2026-10-20)
FDA, Electronic Submission Template for IDE Applications, draft (2026-10-27)
Federal Register 2026-22179 to 2026-22182 (2026-10-29)
TGA, F2026L01167 (CDSS exemption amendments)
GOV.UK, indefinite recognition of CE-marked medical devices (2026-10-21)

First published on our WeChat official account ↗

This article is general information, not regulatory or legal advice for a specific device. Requirements change; check the official sources and the date above.