USA (FDA)

Guidance on PTA and Specialty Catheters – 510(k) Submissions

The FDA has issued updated recommendations for 510(k) submissions covering peripheral percutaneous transluminal angioplasty (PTA) balloon catheters and various specialty catheters. The guidance expands expectations related to bench performance testing, coating assessments, and anatomy‑specific evaluations. It also aims to improve clarity and consistency across submissions. Class II PTA balloon catheters are classified under 21 CFR 870.1250, while specialty catheters fall under 21 CFR 870.1210 and 870.1250. Specialty devices include infusion catheters, cutting and scoring balloons, and balloons designed for uses such as in‑stent restenosis (ISR) or post‑stent dilation.

CANADA (HEALTH CANADA)

Updated Medical Device Application Fee Form

Health Canada has released an updated version of the Medical Device Application Fee Form for use in product registration and licensing submissions.

EUROPE

Best Practice Guidance for Technical Documentation under MDR

TeamNB has introduced harmonized guidance intended to support manufacturers preparing technical documentation under Annex II and III of the MDR. The goal is to help standardize expectations among notified bodies and improve alignment with the regulation’s detailed requirements.

MDR Transition Progress Report

Survey results from 33 TeamNB members indicate that 2022 marked the highest number of MDR certification submissions to date. However, many submissions cover narrower scopes than legacy directive certificates due to incomplete technical documentation. MDR requirements often necessitate multiple certificates for device families, such as separate certifications for each Class IIb implantable product.

Software Bill of Materials (SBOM) Cybersecurity Guidance

New guidance outlines cybersecurity considerations for software‑enabled medical devices and SaMD. It details manufacturer and healthcare provider roles in creating, managing, and using SBOMs, including their application in risk assessment, vulnerability management, and incident response. Key sections address SBOM development principles and approaches for integrating them into cybersecurity workflows.

Cybersecurity for Legacy Medical Devices

A complementary document provides practical recommendations on applying lifecycle cybersecurity practices to legacy devices that cannot be fully protected against current threats. The focus is on safeguarding patient safety and mitigating performance‑impacting vulnerabilities.

MedTech Europe Statement on Regulation (EU) 2023/607

MedTech Europe has acknowledged the European Commission’s Q&A clarifying implementation of Regulation (EU) 2023/607, which amends MDR/IVDR transitional provisions. The amendment officially entered into force on 20 March 2023.

NCAR Exchange Program – Post‑Market Surveillance

Updated materials outline information exchange criteria, procedural requirements, reporting formats, and obligations for IMDRF members participating in the NCAR post‑market surveillance system.

SWITZERLAND (SWISSMEDIC)

Guidance on Clinical Investigations and IVD Performance Studies

Swissmedic has published updated information sheets for sponsors, CROs, and investigators conducting device clinical investigations and IVD performance studies. The documents explain authorization pathways, reporting obligations, and oversight requirements under the frameworks in effect since May 2021 (devices) and May 2022 (IVDs).

Alignment with EU MDR/IVDR Amendments

In line with the EU’s extended transitional timelines, Swissmedic will permit continued market placement of devices holding valid MDR/IVDR certificates throughout the transition period to ensure uninterrupted availability.

Inspections of Class I Manufacturers

Swissmedic has initiated inspections of Class I manufacturers as part of expanded market surveillance. Companies must maintain compliance with regulatory obligations, including declarations of conformity and mandatory notifications.

UNITED KINGDOM (MHRA)

Extended Acceptance of CE‑Marked Devices

A new statutory instrument allows continued acceptance of CE‑marked medical devices in Great Britain beyond 30 June 2023, supporting a smoother transition toward the UK’s future regulatory framework.

Updated UK Medical Device Regulatory Guidance

MHRA has revised several documents to reflect the CE‑marking extensions, including guidance on GB market placement, device registration, UKCA/CE marking rules, labeling, and Northern Ireland requirements.

Device Registration Updates

New guidance has been added for situations in which manufacturers register devices with expired or soon‑to‑expire CE certificates that remain valid under MDR transitional rules.

Medical Device Vigilance

Manufacturers must continue to report adverse incidents and field safety corrective actions to the MHRA. Updated guidance includes revised links to the MORE submissions portal and related APIs.

Software and AI as Medical Devices

MHRA has detailed guidance available for stakeholders involved in developing, assessing, or using SaMD and AIaMD technologies.

New MHRA Fee Structure Effective April 1, 2023

Revised statutory fees have taken effect to ensure sustainable regulatory operations and maintain high‑quality oversight.

ASIA

INDIA (CDSCO)

Circular on Licensing of Class C & D Devices

CDSCO has issued a reminder that inspections for Class C and D device manufacturing licenses must be completed within 60 days of application. Stakeholders transitioning from registration to licensing are advised to apply promptly via the CDSCO online portal.

MALAYSIA (MDA)

Advisory on Unregistered Medical Devices

The MDA continues monitoring market activity to ensure only registered and licensed devices are supplied or used in Malaysia. Stakeholders are urged to verify device registration status through the MDAR online database.

JAPAN (PMDA/MHLW)

Clinical Trial Reporting Requirements for Device Malfunctions

Japan has outlined reporting expectations for device defects and adverse events occurring during clinical trials, consolidated across multiple regulatory notifications.

Centralized Consultation Desk for SaMD

MHLW and PMDA have launched a unified consultation service to support the development and implementation of innovative SaMD products.

TAIWAN (TFDA)

2023 Medical Device Standards Acceptance List

TFDA has published its 2023 updated list of accepted medical device standards, now totaling 1,156, including 76 newly added standards. The agency has also identified outdated standards for replacement.

Approval of 290 Medical Devices (Announcement No. 41/2023)

TFDA has approved 290 medical device products, including domestic and imported Class III and II devices, as well as products from Hong Kong and Macau.

Updated Guidance for Device Registration Review

TFDA has released or updated guidance documents for multiple device categories, including:

• Drug‑coated balloon dilation catheters 
• Hernia repair patches 
• Contact lens care products 
• Radiofrequency cosmetic devices 
• Quantitative shear wave ultrasound liver measurement devices 
• Ophthalmic diagnostic equipment 
• Intense pulsed light therapy systems 
• Hemodialysis concentrates and blood separation products 

PAKISTAN (DRAP)

Consolidated Regulatory Fee Notification

DRAP has issued a consolidated notification updating regulatory fees across a wide range of functions and services. This replaces all previous fee notifications and has been approved by the Policy Board under the Drug Regulatory Authority of Pakistan Act. has been approved by the Policy Board under the Drug Regulatory Authority of Pakistan Act.