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    Asia Regulatory Roundup: TGA Updates Guidance on the Testing of Biological Medicines

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Updates Guidance on the Testing of Biological Medicines   Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on testing biological medicines. Version 2.0 of the guidance features new details on the use of TGA in-house orthogonal testing methods and other changes.   TGA published the first, and until this week only, version of the guid...
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    How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss

    Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales. The situation in India has reached a point where the Advanced Medical Technology Association ...
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    Asia Regulatory Roundup: India Orders J&J and Others to Maintain Output of Knee Implants (3 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Orders J&J, Other Device Makers to Maintain Output of Knee Implants The Indian government has ordered Johnson & Johnson and a clutch of other device makers to maintain output of knee implants at pre-August levels. Officials invoked the legislation to stop the companies from cutting production in response to the price ceiling the government brought into force in ...
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    Asia Regulatory Roundup: China’s Supreme Court Clarifies Legal Scope to Punish Trial Data Fraudsters (22 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Fixes Price of Orthopedic Knee Implants, Tells Manufacturers to Maintain Supply India has capped the price of orthopedic knee implants. The imposition of ceiling prices continues the National Pharmaceutical Pricing Authority’s (NPPA) push to control the cost of medical devices sold in India. Months after setting limits on the prices of coronary stents, NPPA has ...
  • Australia Releases New Joint Replacement Reclassification Guidance

    Australia's Therapeutic Goods Administration (TGA) has posted new guidance reclassifying joint replacements such as hip, knee and shoulder replacement devices. Under the new guidance, applications to reclassify a joint replacement implant from Class IIb (medium-high risk medical devices) to Class III (high-risk medical devices) could require more than one application. A single Class IIb joint implant may have to be 'cloned' into multiple reclassification applications i...
  • France Releases Knee Joint Implant Reimbursement Recommendations

    France's National Commission for the Evaluation of Medical Devices and Technology Health (CNEDiMTS) has just released its opinion on the reimbursement status for the entire class of knee joint implants on the national list of reimbursable products and services (PBDA).  CNEDiMTS has retained most of the proposals of the Working Group on Classification concerning approved indications, prescribing methods and use, and technical specifications for each type of k...
  • New Guidance Document on IDE/INDA Submissions for Knee Cartilage Replacement Products Released

    The US Food and Drug Administration (FDA) today announced a new guidance document titled, Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage. The document provides recommendations for sponsors of an Investigational Device Examption (IDE) or Investigational New Drug (IND) application about what should be included in submission documents for a product intended to "repair or replace knee cartilage." The guidance...