Latest News
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11 January 2013
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The US Food and Drug Administration (FDA) is proposing to reclassify yet another medical device, this time blade-form endosseous dental implants, as class II moderate-risk medical devices capable of
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Latest News
Regulatory Update
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21 December 2012
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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
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Regulatory Update
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15 October 2012
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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
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Regulatory Update
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1 June 2012
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Health Canada is announcing a notice pertaining to the categorization of Therapeutic Products. The notice indicates a product’s mode of action will not necessarily determine whether a product is a
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Latest News
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30 April 2012
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The European Medicines Agency (EMA) has released a new reflection paper on the classification of advanced-therapy medical products (ATMPs)—therapies made from genes and cells—which aims to clarify the
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Latest News
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5 April 2012
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The US Food and Drug Administration (FDA) released two new guidance documents covering Section 513(g) requests for information issued under the Federal Food, Drug and Cosmetic Act (FD&C Act). Section
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Latest News
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16 March 2012
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The US Food and Drug Administration (FDA) is calling for the reclassification of devices used to detect cases of tuberculosis (TB), lowering the current risk classification in a move that it hopes
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Latest News
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21 February 2012
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The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released an updated schedule describing the classification timelines of 26 device classes.The 17
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