Thegmpletter

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February 2019

No. 469

Headlines

Full Issue of The GMP Letter in PDF Format

Download and view the full issue. Read More

Notified Bodies Warn of Future Bottlenecks in Implementing New Device Regs

The European Association for Medical Devices of Notified Bodies (Team-NB) is sounding alarms over the shortage of notified bodies to conduct audits and certify devicemakers in time to comply with the new European medical device regulations. Read More

Health Canada Maps Out Action Plan to Improve Device Safety, Quality

Health Canada released a three-part action plan aimed at improving how devices get on the market, strengthening monitoring and providing more information to consumers about the devices they use. Read More

CDRH Seeks Stakeholder Input on 2019 Guidance Priorities

FDA’s Center for Devices and Radiological Health called for feedback from stakeholders on its priorities for developing guidance for the year ahead. Read More

HSCC Introduces Plan for Cybersecurity ‘By Design’

The Healthcare and Public Health Sector Coordinating Council (HSCC) has developed a new guide for managing the security of medical devices. Read More

China Introduces Routine Overseas Device Inspections

China’s National Medical Products Administration is increasing its scrutiny of foreign manufacturers and will begin routine, risk-based inspections of foreign facilities to confirm they are in compliance with Chinese regulations. Read More

FDA Cites Six Firms for GMP, Other Issues

The FDA rapped six device facilities for a variety of deficiencies identified during inspections, including problems with CAPAs and medical device reporting. Read More

BSI Warns Devicemakers to Migrate CE Certificates Before Brexit Deadline

With a looming hard Brexit exit less than 60 days away, BSI is warning devicemakers that their CE certificates in the UK could become invalid if the UK and EU fail to negotiate an agreeable contract. Read More