Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to comply with Canadian Medical Device Regulations (CMDR) by September 1, 2015.
The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.
The agency has said the new standards are meant to reduce the risk of unintended connections between enteral and non-enteral devices.
The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations.
If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA.
Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.
The medical device tax has a “profound negative effect” on the nation’s jobs and innovation, AdvaMed President and CEO Stephen Ubl and Medical Imaging & Technology Alliance Executive Director Gail Rodriguez explain in an editorial.
Establishing a quality policy and quality objectives is considered a Quality 101 type of activity. If an establishment is ISO 9001 or ISO 13485 accredited or claiming to be in compliance with 21 CFR, Part 820, then they better have a posted quality policy and meaningful quality objectives.
The long awaited unannounced audits for manufacturers of CE marked medical devices were started last year by almost all Notified Bodies. So how can manufacturers prepare for the changes?
A quick review of the violations in 2014 Warning Letters shows that FDA inspectors are scrutinizing multiple areas of operation, from production to receipt of supplies to management responsibilities to CAPA systems.
