May ,14 2013

Chinese Regulators Take Steps to Ease Medical Device Registration

UPDATE October 2013: As of late 2013, the CCC mark
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.
Aug ,30 2011

New Saudi Regulations in Effect for Medical Device Importers

Saudi Arabia’s Medical Device Interim Regulation (MDIR), which includes new documentation requirements for foreign manufacturers importing to the Saudi market, have gone into effect.
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
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
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
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) .

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