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.
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.
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.
Recent regulations implemented by China’s State Food and Drug Administration (SFDA) now allow unannounced inspections of medical device manufacturers.
China’s State Food and Drug Administration (SFDA) strengthened its efforts to protect human health and safety via regulation of medical device recalls.
A new Citigroup Global Markets report on China’s medical device and technology industries expects the market to reach $5 billion in 2012, due primarily to increased hospital purchasing budgets, government investments in hospital upgrades and expansion, and robust hospital construction cycles in China through 2015.
Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by the Beijing FDA (BFDA) rather than the SFDA. Furthermore, the policy applies only to domestic medical devices in China, not imports.
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.