The final months of 2026 include important regulatory deadlines, annual renewal windows, implementation dates and transition cut-offs for medical device manufacturers, importers, authorised representatives and licence holders.

This regulatory calendar covers key actions in the United States, Australia, Thailand, Indonesia, China, Canada, the EU and Switzerland.

The events included in this calendar have different legal natures: some are mandatory renewal deadlines, while others are implementation dates or transition cut-offs. Manufacturers should assess applicability based on their products, regulatory status and market activities.

Key regulatory dates

• 1 October – Australia: TGA annual reporting for custom-made medical devices
• 1 October–31 December – USA: FDA Establishment Registration and Device Listing renewal/review for FY2027
• 1 October–31 December – Thailand: SKYNET annual renewals for applicable Class 2–3 notifications and Class 4 licences
• 17 October – Indonesia: halal requirements transition for Risk Class A medical devices
• 1 November – China: revised NMPA Medical Device GMP enters into force
• Before 1 November – Canada: annual Medical Device Licence renewal
• 9 November – EU: Master UDI-DI requirement for relevant contact lenses
• 28 November – EU: EUDAMED UDI/Devices registration deadline for relevant MDR and IVDR devices under applicable transitional provisions
• 31 December – Switzerland: end of the swissdamed UDI/Devices registration transition period

October 2026

Australia – TGA Custom-Made Device Annual Report

Deadline: 1 October 2026

Manufacturers and sponsors of custom-made medical devices must submit an annual report to the TGA covering custom-made devices manufactured or supplied during the previous financial year.

The reporting period covers the previous 1 July–30 June financial year, and the report must be submitted by 1 October.

USA – FDA Establishment Registration and Device Listing Renewal

Renewal window: 1 October–31 December 2026

Establishments subject to FDA registration must renew their Establishment Registration for FY2027 during the annual renewal period.

Manufacturers and other relevant establishments should also review and, where necessary, update their Device Listings and other registration information. Foreign establishments should verify the information relating to their U.S. Agent and applicable importer information.

The FY2027 Annual Establishment Registration Fee is USD 13,785 for establishments subject to the applicable fee.

The annual registration and listing review must be completed during the 1 October–31 December 2026 renewal period.

Failure to complete the required registration activities may affect lawful distribution or importation of medical devices into the United States.

Thailand – Thai FDA SKYNET Annual Renewal

Renewal window: 1 October–31 December 2026

The annual renewal window applies to applicable Class 2–3 medical device notifications and Class 4 licences.

The applicable renewal route may depend on the regulatory pathway, including Full CSDT, Partial 1 or Partial 2, together with the applicable post-market information and supporting documentation.

Indonesia – Halal Requirements for Risk Class A Medical Devices

Transition date: 17 October 2026

Indonesia’s halal product assurance framework establishes phased requirements according to medical device risk class.

For Risk Class A medical devices, the current transition period ends on 17 October 2026. with the halal certification requirement applying from 18 October 2026.

Manufacturers should assess the applicability of halal certification requirements to their devices, taking into account the product category, materials, manufacturing processes and the applicable Indonesian regulatory provisions.

Medical devices involving materials that are not halal may, under the applicable framework, remain eligible for distribution subject to the required non-halal statement/information and applicable marking requirements.

November 2026

China – Revised NMPA Good Manufacturing Practice for Medical Devices

Effective: 1 November 2026

The revised Medical Device Good Manufacturing Practice (GMP) issued by the NMPA enters into force on 1 November 2026.

NMPA Announcement [2025] No. 107 introduces the revised GMP framework and repeals the previous [2014] No. 64 framework from the same date.

The revised framework strengthens and updates requirements relating to quality management, manufacturing controls, validation and verification, outsourcing and contract manufacturing, change management and risk-based controls.

Individual Chinese technical-standard withdrawals or updates should not be interpreted as a new general 1 November 2026 compliance deadline; their applicability should be verified separately.

Canada – Annual Medical Device Licence Renewal

Deadline: before 1 November 2026

Manufacturers holding Class II, III and IV Medical Device Licences (MDLs) must complete their annual renewal before 1 November 2026.

Under section 43 of the Medical Devices Regulations, manufacturers must confirm annually that the information held by Health Canada remains accurate or submit the required amendments.

Health Canada normally sends the renewal package in early August. If it has not been received by 1 September, the licence holder should contact Health Canada or its regulatory correspondent.

This requirement should be distinguished from the Annual Licence Review (ALR), which applies to Medical Device Establishment Licence (MDEL) holders and is a separate regulatory process.

EU – Master UDI-DI for Contact Lenses

Applicable from: 9 November 2026

The Master UDI-DI assignment solution applies to relevant contact lenses from 9 November 2026 under the amended EU regulatory framework.

The Master UDI-DI is intended to group highly individualised devices that share specified design and performance characteristics.

Contact lenses manufactured before 9 November 2026 are not required to bear a Master UDI-DI solely because of the new applicability date.

EU – EUDAMED UDI/Devices Registration

Deadline: 28 November 2026

The first four EUDAMED modules/functionalities became mandatory to use on 28 May 2026, following publication in the Official Journal of the European Union of the notice confirming their functionality. These are:

• Actor registration
• UDI/Devices registration
• Notified Bodies and Certificates
• Market Surveillance

EUDAMED supports both the MDR and IVDR frameworks. The UDI/Devices module contains device information required under the applicable legislation.

For relevant MDR and IVDR devices covered by applicable transitional provisions, the deadline for registration in the UDI/Devices module is 28 November 2026.

The applicability of the transitional provisions must be assessed case by case, taking into account the device’s regulatory status, the date on which the first unit was placed on the EU market and whether additional units continue to be placed on the market.

For Regulation devices first placed on the EU market on or after 28 May 2026, registration is required before placing the device on the market.

December 2026

Switzerland – swissdamed UDI/Devices

Transition deadline: 31 December 2026

Registration of medical devices, systems and procedure packs in the swissdamed UDI Devices module became mandatory on 1 July 2026, with a transition period running until 31 December 2026.

The transition applies to relevant devices, systems and procedure packs already placed on the Swiss market before 1 July 2026 where additional sales units continue to be placed on the market after that date.

Devices, systems and procedure packs placed on the Swiss market from 1 July 2026 must generally be registered in swissdamed, subject to the applicable transition rules.

There is no transition period for devices, systems and procedure packs subject to certain vigilance obligations, including cases involving a serious incident, Field Safety Corrective Action (FSCA) or trend reporting; registration is required immediately in those cases.

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