Oct 27, 2016

Chinesische FDA schränkt Beratung bei Anforderungen von Zusatzinformationen für Medizinprodukteanträge ein

ZUSAMMENFASSUNG DER WESENTLICHEN PUNKTE DURCH EMERGO: Die China Food and Drug Administration (CFDA) schränkt die...
Sep 23, 2016

Zusätzliche Antragsdokumente in China erforderlich

ZUSAMMENFASSUNG DER WESENTLICHEN PUNKTE DURCH EMERGO: Antragsteller in China müssen Papier- und digitale Kopien der...
Sep 23, 2016

Chinese FDA Adds to Medical Device Submission Document Requirements

EMERGO SUMMARY OF KEY POINTS: Chinese market authorization applicants will have to submit hard and...
Aug 28, 2014

Weiterführende Analyse der neuen IVD-Vorschriften in China

Die Kollegen der Emergo Group in China haben die neuen Zulassungsvorschriften für In-vitro-Diagnostika (IVD) der China Food and Drug Administration (CFDA) tiefgehender analysiert.
Aug 25, 2014

Further Analysis of China's IVD and Medical Device Labeling Rules

Emergo colleagues in China have provided additional analysis of new requirements from the China Food...
Oct 12, 2012

New Chinese Medical Device Labeling Requirements Set for 2013

The State Food and Drug Administration (SFDA), China’s medical device market regulator, will begin requiring all outside labeling and packaging of devices to be provided in Chinese starting in April 2013. According to the SFDA and the Regulatory Affairs Professional Society (RAPS), a recent SFDA notice sent to the agency’s provincial and municipal branches in China mandates that all outside labeling and packaging of medical devices include a version in Chinese. Failure to provide labeling and packaging text in Chinese will prevent manufacturers and sponsors from marketing their devices in China.
Sep 20, 2012

SFDA to Utilize Surprise Inspections of Medical Device Manufacturers in China

Recent regulations implemented by China’s State Food and Drug Administration (SFDA) now allow unannounced inspections...
Jul 12, 2012

SFDA releases China Provisions on Medical Devices Recalls

China’s State Food and Drug Administration (SFDA) strengthened its efforts to protect human health and safety via regulation of medical device recalls.
Jan 12, 2012

Chinese Medical Technology Market Primed for 17% Growth According to Citigroup

A new Citigroup Global Markets report on China’s medical device and technology industries expects the...
Dec 19, 2011

China Allows Clinical Trial Waivers for Some Class II Medical Devices

Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by...

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