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SFDA

サウジアラビアの規制当局が医療機器市場申請(MDMA)の提出期限を調整

このニュースのポイント:

  • サウジアラビア食品医薬品局(SFDA)は、医療機器市場申請(MDMA)提出のための特定期間の更新を発表しました。
  • MDMAの改訂期限は、登録料の支払いと追加情報のSFDA要求への対応に関するものです。

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.

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.

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 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.