Latest News
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14 February 2013
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The US Food and Drug Administration (FDA) has announced the approval of a new medical device intended to treat a rare disease population through the use of a retinal implant.FDA ApprovalThe device,
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Regulatory Update
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6 February 2013
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Australia’s Therapeutic Goods Administration (TGA) has issued guidance regarding the types of evidence that must be submitted by companies to meet the conformity assessment requirements for the
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17 January 2013
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The US Food and Drug Administration (FDA) has proposed a new rule that would classify all hip joint metal-on-metal semi-constrained prosthesis with either cemented or un-cemented acetabular components
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19 June 2012
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The US Food and Drug Administration (FDA) plans to reclassify and implement new special controls for blood access devices used in hemodialysis.In a 19 June 2012 Federal Register posting, FDA announced
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15 May 2012
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The UK’s Medicines and Healthcare product Regulatory Agency (MHRA) said it is moving to act on recommendations made by a Commission in the aftermath of a scandal involving breast implant products made
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14 May 2012
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The UK’s Department of Health (DOH) has released the result of a review into the Poly Implant Prothese (PIP) Scandal, finding the Medicines and Healthcare product Regulatory Agency (MHRA) to have
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Latest News
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27 April 2012
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The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, reports
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Regulatory Update
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11 April 2012
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The new Conformity Assessment standards for silicone in breast implants were released on 9 April by the Brazilian National Institute of Metrology, Quality and Technology (Inmetro).The standards permit
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Latest News
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23 March 2012
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Brazilian regulatory authority Anvisa this week became the latest health regulator to exercise greater enforcement controls over the sale and testing of breast implant products in the wake of a global
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23 March 2012
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Life science manufacturer Johnson & Johnson (J&J) worked to privately phase out a now-controversial metal-on-metal hip implant product in 2009 after the US Food and Drug Administration (FDA) contacted
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