Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2025

USA

1. Guidance on: Quality Management System Information for Certain Premarket Submission Reviews

The guidance highlights the importance of submission of comprehensive, risk-based QMS documentation including quality procedures, validation summaries, risk management, supplier controls, and complaint handling to demonstrate robust quality oversight throughout design, manufacturing, and post-market phases. It also stresses objective, evidence-based documentation aligned with global standards to facilitate regulatory review, underscore patient safety, and support continuous product improvement. Manufacturers are encouraged to identify and close any compliance gaps against this updated QMSR framework and prepare detailed QMS evidence for efficient FDA review and inspection readiness.

AUSTRALIA

2. Guidance document: Complying with Medical Device Cyber Security Requirements

This document details Australia’s regulatory expectations for managing cybersecurity challenges in medical devices that include software or electronic components. It adopts a Total Product Life Cycle (TPLC) framework approach, requiring manufacturers and sponsors to address cyber risks from design and development through post-market monitoring and end-of-life. The guidance links compliance with the Essential Principles under the Therapeutic Goods Act 1989 and Medical Devices Regulations 2002, emphasizing patient safety, device reliability, and data protection. Manufacturers must implement effective quality and risk management systems, apply standards such as IEC 62304, and regularly review and enhance their devices to manage evolving cyber threats.

FINLAND

3. Medical device operator: check the information reported in the register by 31 December 2025

In Finland, the Finnish Medicines Agency (Fimea) has instructed all medical device operators required to report their details to review and, if necessary, correct their information in the relevant register by December 31, 2025. This compulsory annual review is crucial for Fimea to accurately determine and collect the statutory annual supervision fees for the year 2026, as the fee is charged separately for each registered role based on the data in the register at the end of the calendar year. The data check ensures that Fimea’s records, which feed into the national CERE register or the EU’s EUDAMED database depending on the operator’s role, are up-to-date and compliant with the Medical Devices Act

INDIA

4. Guidance on conduct of Medical Device Software under MDR 2017

India’s Central Drugs Standard Control Organization (CDSCO) issued Draft Guidance on Medical Device Software on October 21, 2025, which aims to regulate medical device software by aligning with international practices, distinguishing between Software in a Medical Device (SiMD) and standalone Software as a Medical Device (SaMD), and implementing a risk-based framework. Key requirements include defining intended use, maintaining technical documentation, using an Algorithm Change Protocol, and ensuring ongoing post-market monitoring like Periodic Safety Update Reports and cybersecurity reporting to improve traceability and safety.

5. Risk classification list of Class A (non-sterile and non-measuring) medical devices under the Medical Devices Rules, 2017

The notice from the Drugs Controller General clarifies that certain Class A medical devices, specifically those that are non-sterile and non-measuring, are exempt from licensing to be manufactured or imported in India. Instead, manufacturers and importers are only required to register these devices with the Central Drugs Standard Control Organization (CDSCO). The notice also mentions that the list of these devices is provided in an appendix and is subject to change. Devices that are sterile or have a measuring function are not included in this classification and are subject to different rules.

MALAYSIA

6. Guidance on: establishment for medical device registration submission guide for conformity assessment by way of verification process and submission of application in medcast

This guidance, issued by the Medical Device Authority (MDA) of Malaysia, is intended for local manufacturers and authorized representatives. It outlines the comprehensive submission process for submitting medical device registration applications via the MEDC@ST online platform. The document emphasizes the use of the verification process—a streamlined conformity assessment method for devices already approved by recognized regulatory authorities. It also defines documentation expectations, submission formats, and timelines, aligning with the Medical Device Act 2012 (Act 737) and its associated regulations. The second edition introduces refinements to improve clarity, including updates to recognized authority listings, evidence requirements, and annexes for specific

UMONTENEGRO

7. Guidance on: establishment for medical device registration submission guide for conformity assessment by way of verification process and submission of application in medcast

This guidance, issued by the Medical Device Authority (MDA) of Malaysia, is intended for local manufacturers and authorized representatives. It outlines the comprehensive submission process for submitting medical device registration applications via the MEDC@ST online platform. The document emphasizes the use of the verification process—a streamlined conformity assessment method for devices already approved by recognized regulatory authorities. It also defines documentation expectations, submission formats, and timelines, aligning with the Medical Device Act 2012 (Act 737) and its associated regulations. The second edition introduces refinements to improve clarity, including updates to recognized authority listings, evidence requirements, and annexes for specific

PORTUGESE

8. Portugal and Macau strengthen bilateral cooperation in the regulation of medicines and medical devices.

Portugal and Macau are enhancing bilateral collaboration in the regulation of medicines and medical devices, building on historical ties to promote trade and harmonized regulation within the ‘Big Health’ industry initiative. This collaboration leverages Macau’s strategic role as a platform for economic and commercial cooperation between China and Portuguese-speaking countries, allowing Portugal to explore entry into the broader Asian market. The increased engagement involves high-level discussions and agreements covering science and technology, aiming to foster improved information exchange and potentially simplify regulatory approval procedures for pharmaceutical products and medical devices between the European Union member state and the special administrative region of China.