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  • China Announces 17 New Device Classifications

    China's State Food and Drug Administration (SFDA) issued a notice to the provinces and autonomous regions on 10 December 2012 announcing the classification of 17 medical devices based on expert advice provided to the SFDA. Two products are to be regulated as Class III (high-risk) medical devices: an ultrasound tumor therapy system and a diagnostic imaging device for the skin.  An ultrasound breast imaging diagnostic device and medical imaging software were among...
  • China's Communist Party Calls for Reforms to Drug Regulatory System

    China's Communist party has called for the comprehensive reform of its food and drug regulatory system in order to respond to the concerns of its people, part of a group of reforms called for at a 16 November 2012 meeting of the Communist Party of China's National People's Congress. The focus of the called-for reforms is on improving food and drug safety and the institutional regulatory mechanisms that are tasked with that mandate, explained China's State Food and Drug A...
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    RAPS and China's SFDA to Collaborate on Regulatory Education and Training

    RAPS and China's State Food and Drug Administration Institute of Executive Development (SFDAIED) have signed a memorandum of understanding, creating a cooperative framework to further international education and training for regulatory professionals in China and the US. RAPS is the largest global organization of and for healthcare product regulatory professionals, and SFDAIED is the arm of China's SFDA that provides education and training to the country's regulatory aut...
  • RAPS and China's SFDA to Collaborate on Regulatory Education and Training

    RAPS and China's State Food and Drug Administration Institute of Executive Development (SFDAIED) have signed a memorandum of understanding, creating a cooperative framework to further international education and training for regulatory professionals in China and the US. RAPS is the largest global organization of and for healthcare product regulatory professionals, and SFDAIED is the arm of China's SFDA that provides education and training to the country's regulatory aut...
  • China's SFDA Issues Rule on Imposing Administrative Penalties

    China's State Food and Drug Administration (SFDA) issued a  notice  to the Provinces and Autonomous Regions regarding the application of its Administrative Punishment law, which sets forth the rules for imposing sanctions for violations of the laws and regulations governing drugs and devices.  Local authorities are allowed leeway in deciding the severity of the penalty that is to be imposed on a case-by-case basis, taking into consideration the nature of ...
  • China Classifies, Reclassifies Dozens of Medical Devices After Review

    Following a review conducted by its experts, China's State Food and Drug Administration (SFDA) notified provincial and municipal agencies on 12 September 2012 of the classification of 73 medical devices. Nine devices were classified as Class III (implanted or life supporting devices); 41 as Class II (controls needed to ensure safe use); three as Class I (safety assured through routine administration); and 20 reclassified as non-devices.  Examples of new classif...
  • China: New Labeling Requirements for Imported Devices

    Chinese authorities have announced that as of 1 April 2013, all text appearing on the outside labeling and packaging of imported medical devices must be in Chinese, according to a notice issued to provinces, autonomous regions and municipalities by China's State Food and Drug Administration (SFDA) on 24 September. The Chinese text version can be "attached" to the foreign language, though it is unclear what forms will be permitted. Any devices not in compliance with the r...
  • China: SFDA Issues New PSUR Guidance

    New guidance on submitting periodic safety update reports (PSURs) for drugs was released by China's State Food and Drug Administration (SFDA) on 6 September.  The guidance conforms to the harmonized PSUR standards developed by the International Conference on Harmonization [ICH E2C (R1)].  Foreign importers and joint ventures must submit Line Listings, summary tables (Summary Tabulations) and the company's core data table (Company Core Data Sheet, CCDS) transla...
  • China's SFDA Issues Drug Testing Guidance

    China's State Food and Drug Administration (SFDA) has issued guidance to provincial and municipal food and drug agencies and the Chinese Institute of Food and Drug Testing concerning the implementation of goals contained within China's national 12 th Five Year Plan. The plan calls for accelerating "rapid drug testing technology research" to detect counterfeit and adulterated drug products.  The guidance explains SFDA will be responsible for organizing a nat...
  • China Finalizes Guidance Approving Counterfeit Manufacturer 'Black Lists'

    China's State Food and Drug Administration (SFDA) issued new regulations on 15 August instructing provincial governments to publish on their websites so-called Black Lists of drug and device companies that engage in counterfeiting and related illegal activities.   The websites are to include the name of the company, its business address, the name of the legal representative or responsible person, and the individual's title.  Violations that would justify...
  • China Rule Puts Primary Responsibility for Excipient Quality on Drug Manufacturers

    Pharmaceutical manufacturers will bear primary responsibility for assuring the quality of the excipients used in their products according to a new regulation announced by China's State Food and Drug Administration (SFDA) at a press conference 1 August 2012.  Under the regulation, manufacturers will be required to establish an excipient quality management system, enter into quality agreements with excipient suppliers and implement supplier audits. The regulation f...
  • China: SFDA Launches New Device Compliance Program

    China's State Food and Drug Administration (SFDA) has launched a new medical device manufacturing inspection program for the Provinces and Municipalities to implement during an inspection of a medical device manufacturing site.  The inspection program's 15 articles require local regulatory authorities to undertake a number of measures, such as a follow-up inspection in cases where serious flaws are uncovered and ensuring that the company has established a quality...