China’s NMPA Launches Voluntary Device Master File Process

China – China’s NMPA Launches Voluntary Device Master File Process

Chinese regulators are launching a record filing process for medical device master files (DMFs). DMFs are used by NMPA reviewers and Chinese market...
TGA Plans GCP Inspection Program

Australia – Australia Explores Adopting UDI System

Device companies were given a tight deadline on Monday to comment on a new proposal that would establish a unique device identification (UDI) system...
S. Korean devicemaker debuts AI-based diagnostics platform

South Korea – S. Korean devicemaker debuts AI-based diagnostics platform

JLK Inspection, a member company of the K-ICT Born2Global Centre, is introducing its latest AI-based medical image diagnosis system, the AIHuB, a cutting-edge all-in-one...
China FDA Reorganization: Impact for medical device registrants

China – China FDA Reorganization: Impact for medical device registrants

The China Food and Drug Administration (CFDA) is being reorganized into the China Drug Administration (CDA). A new State Administration for Market Supervision...
TGA Plans GCP Inspection Program

Australia – Regulation of Software as a Medical Device

Software is becoming increasingly important in medical devices. In addition, it is becoming more and more important as a medical device in its own...
China FDA Reorganization: Impact for medical device registrants

China – What does the U.S.-China trade war mean for medical device companies?

The ongoing trade war between the United States and China affects everything from tooling and mold-building to commodity medical devices when medtech is concerned, according to...
Hong Kong Regulators Launch Online IVD Classification Tool

China – Hong Kong Regulators Launch Online IVD Classification Tool

EMERGO SUMMARY OF KEY POINTS: Hong Kong regulators unveil online classification platform for IVD devices. The MDCO IVD platform is designed similarly to an...
Australian TGA Regulatory Changes for Implantable Medical Devices Starting in December 2018

Australia – Australian TGA Regulatory Changes for Implantable Medical Devices Starting in December 2018

Australian regulators will begin requiring some implantable medical device manufacturers to provide additional product information to patients starting in December 2018. The Therapeutic...
Malaysian Regulators Launch New Medical Device Databases

Malaysia – Malaysian Regulators Launch New Medical Device Databases

he Malaysian MDA has launched two databases to provide information on medical device registrations and licensed establishments MDA’s database for device registrations is...
Chinese Regulators Revamp Innovative Medical Device Review Process

China – Chinese Regulators Revamp Innovative Medical Device Review Process

EMERGO SUMMARY OF KEY POINTS: The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program. NMPA...

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