Our May 2025 MedTech news covers the Swiss Federal Council’s guidelines for expanding medical devices supply, an upcoming focus campaign to check Swiss compliance with importer obligations, and the new manufacturing incident report form soon to be mandatory in Switzerland and the EU.
The FDA’s expansion of unannounced inspections at foreign manufacturing plants also features, along with the latest regarding MDSAP’s newest member, and guidance and legislation updates from Japan, South Korea, and China.
For all this and more, read on…
MedTech news from Switzerland & the EU
Swiss Federal Council defines guidelines for expanding medical devices supply
At its meeting on 30 April, the Swiss Federal Council decided on how to implement Motion 20.3211, which aims to expand sources of medical device supplies in Switzerland beyond the EU – in particular devices authorised by the FDA.
To ensure adequate medical device supply and to guarantee patient safety, the Federal Council has defined guidelines and will assign responsibility for controls to independent agencies.
A working group with participants from the FOPH, Swissmedic, SECO, and the FDFA is now exploring the necessary changes to the legal framework. Read more here.
Swissmedic to launch importer compliance campaign
This year, Swissmedic will be launching a focus campaign to check compliance with importer obligations.
The focus campaign will involve on-site inspections of a selection of Swiss importers. Those selected by Swissmedic as part of the random sample will receive written prior notice.
Swissmedic has produced an information sheet for authorised representatives, importers, and distributors that provides detailed information on the obligations of importers. See more on this here.
EU Commission introduces new MIR form
On 5 May, the EU Commission published a new version (7.3.1) of the form for reporting serious incidents. The new manufacturer incident report (MIR) form can also be used for submitting reports to Swissmedic, provided that the form is completed in accordance with the CH guide for Switzerland-specific content.
The form will be mandatory for incidents in the EU and Switzerland as of November this year. Access the EU form here.
EU Commission to launch coordinated assessment for CI/PS pilot
This month, Member States, supported by the EU Commission, announced the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States, as per Articles 78 of the MDR and 74 of the IVDR.
The pilot will allow sponsors to submit a single application for pilot coordinated assessments, aiming to facilitate the implementation of a harmonised, predictable process across Member States that reduces administrative burden, and increases transparency and consistency.
Read more on the pilot benefits, who can apply, and the selection process here.
MedTech Europe shares targeted measures to expedite MedTech access
This month, MedTech Europe has published four urgent targeted measures to enhance rapid access to safe medical technology while protecting innovation.
In its published paper, “Towards a Revised EU Regulatory Framework for Medical Technologies”, the organisation highlights making initial product approval and change notification processes faster, and more efficient, predictable, and cost effective. The introduction of a dedicated and accelerated pathway for breakthrough innovations is also proposed, as well as a shift to lifetime risk-based certification to reduce duplication and burden.
MedTech news from the US & South Africa
FDA expands unannounced inspections at foreign manufacturing plants
On 6 May, the Office of Inspections and Investigations (OII), part of the FDA, communicated the expansion of its program pilot of unannounced inspections beyond China and India.
The move aims to ensure that foreign companies receive the same level of regulatory oversight and scrutiny as domestic businesses. For context, the FDA can perform both announced and unannounced inspections. Until now, inspections of domestic facilities have in general been unannounced, while inspections of relevant entities outside the US have been pre-announced.
Alongside this change, the FDA also intends to evaluate its policies related to its foreign inspection program to improve clarity and integrity.
This recent announcement marks a significant policy shift towards equal treatment of domestic and foreign medical device manufacturing facilities, and more closely aligns with recent European policy. Find out more here.
SAHPRA joins MDSAP
The South African Health Products Regulatory Authority (SAHPRA) has joined the Medical Device Single Audit Programme (MDSAP) as an affiliate member, expanding its ability to monitor the manufacturing of medical devices beyond South Africa’s borders.
SAHPRA’s membership will facilitate the improved regulation of medical devices and IVDs in South Africa by increasing the authority’s global regulatory reach to both audit and monitor adherence to quality standards.
Find out more here, and for more on the regulatory landscape in South Africa, see our article here.
MedTech news from Asia
Japan’s PMDA plans issue of Early Consideration
Japan’s PMDA has announced its intention to implement consultation services and reviews that appropriately respond to innovation – including issuing Early Consideration and formulating clinical evaluation guidelines based on the latest scientific knowledge.
See here for the PMDA’s compilation of documents related to Early Consideration, as well as issues such as the practical application of innovative technologies.
South Korea’s MFDS revises K-GMP regulations for medical devices & IVDs
South Korea’s Ministry of Food and Drug Safety (MFDS) has revised legislation related to manufacturing and quality control standards. MFDS Notice No. 2024-88 and MFDS Notice No. 2024-90 for medical devices and IVDs respectively, entered into force in December last year, and have now been consolidated as MFDS Notice No. 2025-22. Read more on this here.
China’s NMPA publishes priority medical device approval guidance
Last month, the NMPA published the “Implementation Rules for the Priority Approval Review of Medical Devices”. Based on the “Medical Devices Priority Approval Review Procedures”, the new guidance details the path to market for urgently needed medical technologies.
The document covers general provisions, priority application and formal review, review of priority applications for urgent clinical needs and national major science and technology projects, confirmation of review opinions, objection handling, and more. Read more on this here.
China welcomes innovation with new guidance
The NMPA has recently published the “Implementation Rules for the Special Review of Innovative Medical Devices”. Based on the “Innovative Medical Devices Review Procedures” issued in 2018, the guidance details the market pathway for novel medical technologies.
Aiming to actively facilitate innovation growth, the document covers general provisions, innovation application and formal review, expert selection and review, objection handling, and more. Find out more here.
That concludes our May 2025 MedTech news roundup. We’ll be back in June with more medical device news and updates.
Found this useful? To receive our MedTech news direct to your inbox, you can subscribe to our monthly Knowledge update.