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China

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 Beratung bei Anforderungen von Zusatzinformationen bei Medizinprodukte-Zulassungsanträgen ein.
  • Anträge auf eine persönliche Beratung durch die CFDA müssen ab sofort online eingereicht werden.
  • Einfachere Fragen in Bezug auf angeforderte Zusatzinformationen können online oder telefonisch geklärt werden.

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 and Drug Administration (CFDA) regarding in vitro diagnostic (IVD) device registrations.

According to CFDA Administrative Order No. 5, all Class I, II and III IVDs imported into China will have to undergo new CFDA registration requirements beginning October 1, 2014.

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.