IVDR Clinical Performance Studies: Considerations for EU Approval
In other articles, we have covered considerations for manufacturers about clinical investigations when pursuing CE marking under the…
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Australia TGA Approval: Leveraging CE Certification and FDA Clearance
Australia has long been considered a market where device CE certification has presented the easiest pathway to entry for…
Medical Device Vigilance Reporting for Australia TGA Compliance
As in other jurisdictions, the Therapeutic Goods Administration (TGA) has established several requirements related to medical device vigilance reporting…
Medical Device Registration in India
The Central Drug Standard Organization (CDSCO), which falls under the jurisdiction of the Ministry of Health…
Swissmedic’s Changes on IVD Notifications
Swissmedic, has recently issued a revised version of a guidance document that addresses In Vitro Diagnostic Devices. This updated guidance…
Applying for an MD-15 Import License for Medical Devices in India
To apply for an MD-15 Import License in India, manufacturers must abide by the medical device regulations of the…
FDA Final Guidance on Cybersecurity in Medical Devices
On November 2nd, 2023, the FDA organized a webinar to discuss the recently issued Final Guidance for Medical Device…
Inclusion of CH-REP in Communication on Vigilance Topics
Swissmedic has now specified that if the reporting is done by a manufacturer domiciled outside of Switzerland and Liechtenstein, the…
EC Regulation 2023/2197: UDI Assignment for Contact Lenses
The EC has decided to amend the MDR with regards to the assignment of Unique Device Identifiers (UDI) for Contact…
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