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.
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...
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.
Nov 14, 2012

Chinese Regulators Pursue Heavier Penalties for Medical Device Violations

The State Food and Drug Administration (SFDA) of China has set new ruleseffective January 1, 2013 that would mete out more severe punishment to medical device and pharmaceutical manufacturers for certain violations. The SFDA notice lists several violations that warrant more aggressive enforcement of China’s Administrative Punishment Law applied to drugs and medical equipment, while at the same time granting local and regional officials more discretion in determining penalties for violators. Violations warranting more severe penalties include production and sale of counterfeit or substandard medical devices that cause injury; production of counterfeit or substandard devices by companies found previously to have committed similar violations; and avoiding SFDA supervision or inspection or tampering with evidence that would incriminate the company in question.
Mar 27, 2013

China: State Food and Drug Administration Renames Itself China Food and Drug Administration (CFDA)

The State Food and Drug Administration (SFDA), China’s medical device market regulator, has renamed itself the China Food and Drug Administration (CFDA) .
Mar 28, 2013

China: State Food and Drug Administration auf China Food and Drug Administration (CFDA) umbenannt

Die State Food and Drug Administration (SFDA), die in China für Medizinprodukte zuständige Behörde, hat ihren Namen auf China Food and Drug Administration (CFDA) geändert.
May 14, 2013

Chinese Regulators Take Steps to Ease Medical Device Registration

UPDATE October 2013: As of late 2013, the CCC mark is no longer required for medical devices . See official notification 2013 NO.52 (text in Chinese). The China Food and Drug Administration (CFDA) has announced steps in recent weeks to improve its medical device classification process and ease the path to market for innovative devices.
May 15, 2013

Chinesische Behörden setzen Maßnahmen zur Vereinfachung der Zulassung von Medizinprodukten

Die China Food and Drug Administration (CFDA) hat vor kurzem einige Maßnahmen bekanntgegeben, die die Klassifizierung von Medizinprodukten erleichtern und die Markteinführung von innovativen Produkten vereinfachen sollen.
Dec 17, 2013

Chinese Regulators to Launch Simplified Registration Renewal Process in 2014

The China Food and Drug Administration (CFDA) implemented a simplified certification renewal process on January 1, 2014 for medical devices. With the exception of devices with major changes, manufacturers seeking to renew their medical device registrations in China will face fewer documentation requirements and potentially faster re-certifications.
Dec 18, 2013

Ab 2014 vereinfachte Erneuerung der Registrierung von Medizinprodukten in China

Die China Food and Drug Administration (CFDA) wird am 1. Januar 2014 ein vereinfachtes Verlängerungsverfahren für Medizinprodukte-Zulassungen einführen. Mit Ausnahme von Produkten mit wesentlichen Änderungen müssen Hersteller, die Ihre Medizinprodukte-Zulassungen in China verlängern wollen, nun weniger Dokumente einreichen, was möglicherweise die Erneuerung der Zertifizierungen beschleunigt.

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