Chinese National Medical Products Administration (NMPA) slows rates of approvals as overhaul of regulatory system continues.

Summary of the latest global medical device regulatory trends including UDI, post-market surveillance and quality management.

Embedding human factors engineering (HFE) and usability studies early in medical device design and development...

China’s National Medical Product Administration (NMPA) has clarified various technical review and information guidelines related...

The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products...

The US Food and Drug Administration has called for test cases from developers for its...

The US Food and Drug Administration has called for test cases from developers for its...

TÜV Süd is now the second Notified Body designated to issue CE Mark certifications under...

Spotlight on MDR impact on drug-device combination products The European Medicines Agency (EMA), which oversees...

The Saudi Food and Drug Authority (SFDA) has prepared adjustments to its medical device and...

The Saudi Food and Drug Authority (SFDA) has prepared adjustments to its medical device and...

With the European Medical Devices Regulation (MDR) coming into force in less than one year,...

EMERGO BY UL SUMMARY OF KEY POINTS: Connected medical device design and develoment paradigm shifting...

EMERGO BY UL SUMMARY OF KEY POINTS: Connected medical device design and develoment paradigm shifting...

EMERGO BY UL SUMMARY OF KEY POINTS: US FDA publishes final guidance on Q-Submission Program...