The listed products, including both physical devices and software as a medical device (SaMD), will not be listed on the Australian Register of Therapeutic Goods (ARTG) or subject to regulatory scrutiny by the TGA.

The NMPA made revisions to its medical device classification catalog including the down-classification of 15 device types, while a CMDE announcement accompanied the end of the UDI pilot program and the beginning of compliance enforcement for some devices.

Ordinance No. 384/2020 allows for alternatives to on-site inspections, removes issuance data requirements for test reports, and makes INMETRO certificates valid indefinitely as long as maintenance audits are performed.

FDA rolls out evolving regulatory approach for AI/ML-based software as a medical device (SaMD)

Expert panelists appointed across 12 sectors for EU MDR, IVDR support

User interface design and safety issues for medical device designers as home healthcare products become more common

Health Canada published changes to the Medical Devices Regulations (CMDR) that will empower regulatory authorities and place greater emphasis on the life cycle of medical devices.

STeP is modeled after the Breakthrough Devices Program and offers support for medical devices and combination products that aim to improve safety of current treatments and diagnostics.

Obvious use risks posed by medical devices and products must still be mitigated against by product developers and designers

Keeping the user experience centered during the early stages of designing a medical device can help you to optimize healthcare outcomes and avoid use issues down the line.

An updated guidance document extends the deadline for companies to deal with applications and submissions placed on hold during the COVID-19 pandemic, while virtual advisory committee meetings and additional alternatives to on-site MDSAP audits will be available.

The agency plans to maintain continuity and ensure a blend of flexibility and regulatory oversight as it transitions to longer-term transition measures for combating the pandemic.

UK MHRA registration requirements and compliance grace periods for medical devices and IVDs

UDEM becomes eighteenth Notified Body designated under the European Medical Devices Regulation (MDR)

The German organization is now listed in the NANDO database, but concerns remain about whether there will be a sufficient number of Notified Bodies to handle the workload in 2022.