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therapeutic goods (medical devices)

  1. Marcelo Antunes

    Medical Device News TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

    TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy Continue reading...
  2. Marcelo Antunes

    Medical Device News New Zealand – Therapeutic Products Regulatory Scheme consultation

    Comments on both the Therapeutic Products Bill and the Therapeutic Products Regulatory Scheme: Consultation document. Continue reading...
  3. Marcelo Antunes

    Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices

    Health Canada - Proposed Changes to the Therapeutic Products Directorate’s List of Recognized Standards for Medical Devices Proposed Changes to the Therapeutic Products Directorate’s List of Recognized Standards for Medical Devices - Canada.ca
  4. M

    US FDA "Single Audit Program" and Brazil

    Some Background: I was asked yesterday by Kim Trautman of FDA to participate in the Medical Device Single Audit Program (MDSAP). The company for which I'm Regulatory Manager has been a participant in the Voluntary Audit Report Submission Pilot Program (VARSP) for the past two years, and MDSAP...
  5. P

    GMP or quality system "requirement" comparison for different sector

    Dear All, Does anyone have or have seen a comparison of requirement for GMP (or quality system) of different products, food, drug, cosmetic, medical device, and biologics. Many thanks,
  6. G

    CE Marking a product for a company (customer) based in America

    I've recently been asked to CE mark a product for a company (customer) based in America, who are the manufacturer of the product in question and also want to retain the term "manufacturer" in line with the CE mark. They need the CE mark approval in order to get TGA registration as their current...
  7. R

    Australia and New Zealand joint scheme for Regulation of Therapeutic Goods

    Hi all, Here is an update on the future ANZTPA initiative: http://www.tga.gov.au/about/international-anztpa-factsheet.htm Cheers, Ronen.
  8. F

    What Combination (Combined Advanced Therapy Product) Products are Approved in the EU?

    Hi, I am trying to figure out what Combination Products are approved in the EU. The definition for Combination products in the EU is a "combined advanced therapy product’ is defined as one that incorporates as an integral part one or more medical devices, or active implantable medical devices...
  9. arios

    Important Regulatory changes in Australia

    Team: I just received this notification which I found worth sharing here at the cove. Actually I am just copying a portion because there was some publicity related involved, so I tried to keep only the part w/o such commercial claims: "We are writing to communicate three important changes to...
  10. P

    System or Method for Classification of Medical and Surgical Products

    I would like to enquire whether any of the forum members are aware of a system for the classification of surgical items. Such a classification may allow us to compare prices of surgical items relative to their quality and therapeutic use within a category. This may assist in developing a...
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