Canada: Non-compliant device labels may now be relabelled/corrected after importation
Canada: Priority review process for device applications to be streamlined and expanded
Canada: Guidance on the requirements for recognising an MDSAP Auditing Organization
Canada: Consultation on pre-market requirements for medical device cybersecurity
Canada: Draft guidance on licensing requirements for 3D printed medical devices
Canada: ‘Action Plan on Medical Devices’ is released
USA: Incorporating FDASIA modifications to the medical device classification procedures
USA: Reclassification of ECT devices; effective date of requirement for a PMA for ECT devices for certain specified intended uses
USA: Insulin therapy adjustment devices placed into Class II
USA: Class II classification for the active implantable bone conduction hearing system
USA: Class II classification deemed appropriate for the high flow humidified oxygen delivery device
USA: Meprobamate test system classified into Class II
USA: Withdrawal of proposed rules on laser products’ performance standard and electronic labelling submission for certain home-use devices
USA: Proposed regulation of medical device de novo classification process
USA: Proposal to end temporary extension of GUDID’s grace period
USA: Revised policy on UDI direct marking compliance dates
USA: Policies for implementing Breakthrough Devices Program set out in new guidance
USA: Guidance released on manufacturing site change supplements
USA: Comments sought on draft guidance concerning blood glucose monitoring test systems for prescription point-of-care use
USA: Draft guidance issued on self-monitoring blood glucose test systems for over-the-counter use
USA: Guidance drafted on developing and labelling in vitro companion diagnostics for a specific group or class of oncology therapeutic products
USA: Draft guidance documents concerning CLIA waiver applications revised and re-issued
USA: Further plans to modernise the pre-market notification (510(k)) programme
USA: ‘Medical Device Enforcement and Quality Report’ shows improved compliance rates
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