News and Updates
CMC Medical Devices Joins Registrar Corp: Expanding Global Regulatory Expertise
CMC Medical Devices Joins Registrar Corp: Expanding Global Regulatory Expertise [Malaga, Spain, and Hampton, VA — October 30, 2025] — CMC Medical Devices (CMC), a Spain-based global regulatory consulting firm specializing in medical devices and in vitro diagnostics (IVD), has [...]
New EU Harmonized Standards for Surgical Clothing, Medical Face Masks, and Sterilizers
What is Decision (EU) 2025/2078? On 17 October 2025, the European Commission adopted Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182 regarding harmonized standards applicable to surgical clothing and drapes, medical face masks, and sterilizers for medical [...]
Switzerland adopts EU rules on electronic instructions for use for medical devices
On 8 August 2025, Swissmedic announced the immediate implementation of Commission Implementing Regulation (EU) 2025/1234 on electronic instructions for use (e-IFUs). The measure aligns Switzerland with the latest EU requirements and extends the permitted scope for e-IFUs when devices [...]
New EU manual on borderline & classification of medical devices and IVDs
The European Union has released the 4th edition of the Manual on Borderline and Classification for Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). This update provides practical, case-based guidance to help stakeholders determine whether a product falls [...]
Australia’s approach to regulating software-based medical devices
The rapid rise of digital health technologies is transforming healthcare delivery. Software is no longer just an accessory to medical devices, it can operate as a medical device on its own. To guarantee safety and performance, the Therapeutic Goods Administration [...]
Swissdamed UDI Devices module: medical device registration now available
On 18 August 2025, Swissmedic launched the new UDI Devices module in swissdamed, the national database for medical devices in Switzerland. This update makes it possible to register medical devices, in vitro diagnostic medical devices (IVDs), as well as systems [...]
China and Malaysia launch reciprocal medical device reliance pilot programme
On 30 July 2025, the regulatory authorities in China and Malaysia launched a two-month pilot programme to grant companies accelerated access to market for certain medical devices. The pilot phase will end on 30 September 2025. A reciprocal agreement for [...]
Swissmedic information sheet on systems and procedure packs
From 4 August 2025, Swissmedic clarifies the obligations for systems and procedure packs (SPPs) containing at least one medical device in Switzerland and Liechtenstein, under the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). [...]
FDA MDUFA Small Business Benefits: eligibility and reduced fee options
The Medical Device User Fee Amendments (MDUFA) authorize the FDA to collect user fees for certain types of medical device submissions and for the annual establishment registration. For small companies in the sector, these costs can be reduced—or in [...]
