The Finnish Medicines Agency (Fimea) has published a guidance document consolidating the principal regulatory requirements and applicable guidelines for the manufacture of custom-made medical devices1. The document is intended for industry stakeholders and provides a structured overview of custom-made device…
The Finnish Medicines Agency (Fimea) has published a new infographic1 to support researchers in the design of clinical trials in accordance with Article 82 of Regulation (EU) 2017/745 on medical devices. The infographic describes the special features of research under…
On 19 January 2026, the Finnish Medicines Agency (Fimea) announced the publication of guidance website addressing the use of artificial intelligence (AI) in medical devices1. This initiative follows the entry into force of the European Union’s AI Act (Regulation (EU)…
Medical Device Coordination Group guidance document MDCG 2025-8, Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles, was published in November 20251. This document aims to provide guidance on the implementation…
A pilot coordinated assessment of clinical investigations and performance studies has been launched1 across multiple Member States as per Article 78 of Regulation (EU) 2017/745 and Article 74 of Regulation (EU) 2017/746. This pilot will allow sponsors to submit a…
In December 2025, MDCG 2025-10, Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices, was published by the Medical Device Coordination Group1. The main objectives of this guidance are: to describe the post-market surveillance (PMS)…
Medical Device Coordination Group MDCG 2025-9, Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746, was published in December 20251. A medical device or in vitro diagnostic (IVD) may be described as a breakthrough device (BtX) when it represents…
The first revision of Medical Device Coordination Group MDCG 2025-7, MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles, was issued in December 2025. Revision 1 includes…
Commission Decision (EU) 2025/2371, which was published on 27 November 2025, confirms that the first four modules of the European Database on Medical Devices (EUDAMED) have achieved functionality and meet the required functional specifications1. To ensure legal certainty and a…
COM(2025) 1023 final (dated 16 December 2025)1 sets out proposed amendments to Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) that have been designed to simplify and reduce the burden of the…
The Egyptian Drug Authority has announced the issuance of import approvals for refurbished spare parts for medical and laboratory equipment that are not classified as standalone devices1. Companies that import refurbished spare parts for medical and laboratory equipment that are…
The Egyptian Standard ES 5526-3, Transfusion Equipment for Medical Use – Part 3: Blood-Taking Sets for Single Use, was adopted on 22 October 2025 and will enter into force the day after its date of publication in the Official Gazette.…
The Egyptian Drug Authority (EDA) has published1,2 guidance on the basic requirements for accepting import approval requests for medical equipment and their spare parts via the MeDevice Platform. As part of the EDA’s efforts to streamline procedures for receiving such…
A partial amendment1 of the Sanitary Technical Regulations for obtaining a certificate indicating whether or not health registration, a health notification, or a mandatory health notification is required for products for human use and consumption subject to control and surveillance…
Increasingly, collaboration with influencers is being used as part of marketing activities to increase awareness of medical devices and strengthen dialogue with end users. Although influencer marketing holds great potential when it comes to communicating medical devices in a way…
To support the export trade of medical devices and standardise the handling of service matters relating to the issuance of export sales certificates for medical devices by drug regulatory authorities, the National Medical Products Administration has revised and reissued the…
After soliciting public opinions and organising expert reviews, the National Medical Products Administration (NMPA) has determined two recommended medical device industry standard development plans and published them for public comment1. The project plans apply to the following recommended industry standards:…
Interested parties had until 10 January 2026 to submit comments on the draft National Standard of the People’s Republic of China GB 12260-20XX, Cardiopulmonary bypass systems – Roller blood pumps1. When finalised, this standard will replace GB 12260-2017. The revised…
On 4 November 2025, the National Medical Products Administration released a new version of the Good Manufacturing Practice for Medical Devices, which will come into effect on 1 November 20261. This revised version significantly updates the 2014 version to strengthen comprehensively the…
New and revised medical device industry standards listed in Table CN3 have been recently approved and published1. The standard number, name, status and implementation date are detailed in the table. Table CN3. New and revised medical device industry standards…
The following Guiding Principles have been released by the National Medical Products Administration1 and the Center for Medical Device Evaluation2. Final documents: Guiding Principles for the Registration Review of Human Leukocyte Antigen (HLA) Genotyping Test Reagents (9 January 2026);…
Announcement No. 132 of 2025 from the National Medical Products Administration concerns adjustments to certain content for 31 types of medical devices in the Medical Device Classification Catalogue1 (see Table CN1). From the date of Announcement No. 132 of 2025…
The National Medical Products Administration has developed and published a Catalogue of High-End Medical Devices Priority for Approval (2025 Edition)1. The Administration will give priority to the review of medical device registration applications for devices listed in the Catalogue (see…
Version 5 of the Guidance on managing applications for medical device licences was published on 21 November 20251. It is scheduled to take effect on 2 February 2026 and, at that time, will replace the Guidance Document: Management of Applications for…
The Fees in Respect of Drugs and Medical Devices Order has been amended to specify the new fees for medical device applications that will apply from 1 April 20261. Details of the fees that will apply from 1 April 2026…
A consultation was held until 17 January 2026 on proposed amendments to the Medical Devices Regulations concerning establishment licences1. These proposed amendments would facilitate better international alignment, close certain compliance and enforcement gaps, and help reduce the administrative burden while…
Health Canada has reaffirmed its commitment to global regulatory harmonisation by adopting guidance aligned with the International Medical Device Regulators Forum (IMDRF)1. The guidance outlines how medical device manufacturers should organise regulatory submissions using the IMDRF Table of Contents (ToC),…
Health Canada has issued an advisory notice to manufacturers on preparing new device licence applications for Class III and Class IV diagnostic ultrasound systems and transducers1. This advisory notice references relevant guidance documents, and provides acceptable acoustic output levels and…
Companies will have until 30 May 2026 to cancel notifications for sodium chloride-based products intended for nasal irrigation that are classified as medicines and to register them as Class IV medical devices1. This regulatory change will apply to both powdered…
In December 2025, the Manual for Registering Healthcare Materials with Anvisa (Brazilian Health Regulatory Agency) was updated1 to address the changes set forth in the following: Anvisa Resolution RDC No. 751 of 15 September 2022, which sets out the…
The National Health Surveillance Agency (Anvisa) has unified the subject codes used in applications for the Certificate of Good Manufacturing Practices (Certificado de Boas Práticas de Fabricação, CBPF) for medical devices to simplify the regulatory process, reduce bureaucracy, and align…
Brazil’s National Health Surveillance Agency (Anvisa) has published a new version of the Manual for the Registration of Medical Equipment and Software as Medical Devices [SaMD] with Anvisa1. This Manual update is part of an ongoing process of revising the…
As part of the digital transformation of its services, the Brazilian National Health Surveillance Agency (Anvisa) has integrated a new tool into its Solicita system to generate certificates for registered or notified medical devices1. This tool became fully operational on…
Guidance entitled Advertising therapeutic goods on social media was updated on 5 November 2025 to include comprehensive advertising guidelines for social media marketing tools/platforms/channels and to add new resource links1. The purpose of this guidance is to help advertisers understand…
Public feedback is being solicited on proposed changes to the conformity assessment procedures for medical devices1. The consultation period runs from 18 December 2025 to 27 February 2026. The proposed changes are intended to improve the clarity and efficiency of…
The Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025, which specifies the updated information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG), came into effect…
Guidance on how medical devices must comply with the Essential Principles was updated in November 2025 to include information on Essential Principle 131. Essential Principle 13 of Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002 specifies the requirements for information…
A consultation has been initiated to seek stakeholder feedback on proposed amendments aimed at improving transparency regarding disruptions to the supply of medical devices1. The consultation period runs from 7 January 2026 to 20 February 2026. The proposed amendments are…
Interested parties had until 23 January 2026 to submit comments on a proposal to support sponsors who may not be able to meet the new Unique Device Identification (UDI) requirements by the compliance deadline1. In March 2025, the Therapeutic Goods…
ANMAT – the National Administration of Drugs, Food and Medical Devices – has established a simplified process for the authorisation of establishments that manufacture and/or import low-risk medical products1. The process is framed within the provisions of Law No. 16,463,…
The National Administration of Drugs, Food and Medical Devices (ANMAT) has released an updated framework for accrediting compliance with technical requirements through the recognition of international certifications1. ANMAT Decree No. 892/2025 applies exclusively to medical products of risk Classes I…
A technical performance and safety white paper entitled Medical Imaging Device Cybersecurity: Critical Outage Situations and Response was issued by the industry association AdvaMed in August 20251. This technical document outlines common imaging device outage scenarios and manufacturers’ recommended steps for…
The Center for Devices and Radiological Health (CDRH) is seeking input from interested parties and the public on best practices, methodologies, and approaches for measuring and evaluating real-world performance of artificial intelligence (AI)-enabled medical devices1. This includes approaches to detect,…
The Food and Drug Administration (FDA) has issued guidance1,2 to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. It is hoped that these recommendations…
Final guidance for industry entitled, Medical Device User Fee Small Business Qualification and Determination, was published on 31 July 20251,2. This guidance updates the previous version of the guidance from 2018, inter alia, to describe how the Food and Drug…
Final guidance entitled Animal Studies for Dental Bone Grafting Material Devices--Premarket Notification (510(k)) Submissions has been published by the Food and Drug Administration1,2. This guidance document provides recommendations for animal study design and animal study information to be included in…
The Food and Drug Administration (FDA) has published the medical device user fees for device submissions and annual fees both for periodic reports and registration of establishments for fiscal year (FY) 2026 (1 October 2025 to 30 September 2026)1. The…
During an emergency, appropriately safe and effective in vitro diagnostic (IVD) tests are critical to the diagnosis, treatment, tracking, and interruption of transmission of infectious diseases during outbreaks, as well as for diagnosing and treating diseases or conditions caused by…
The Food and Drug Administration (FDA) has classified the devices identified in Table US2 into Class II, subject to special controls. The special controls that apply to each device type form part of the codified language for that classification. In…
Comments are being accepted until 6 December 2025 on a Draft Resolution of the Cabinet of Ministers of Ukraine ‘On Approval of the Technical Regulation on Medical Devices’ to update1 the provisions of the current Technical Regulation on Medical Devices…
