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    Class I & II
    9 Articles  in this category
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      Contents

      Class I & II

      9 Articles in this category
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      0. Record of Amendments

      Medical Devices Class I & II Australia The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaime...

      1. Authorities

      Medical Devices Class I & II Australia This section provides an overview of the Authorities involved in setting regulations and managing compliance with the medical devices in scope. The Australian...

      2. Medical Device Classifications

      Medical Devices Class I & II Australia This section provides the regulatory classification of the medical devices in scope. 2.1 Preface Medical devices are classified according to t...

      3. Compositional Aspects

      Medical Devices Class I & II Australia This section provides the compositional requirements for the category and/or products in scope and information on permitted nutrients, ingredients, and additives. NOT APPLICABLE

      4. Labeling Requirements

      Medical Devices Class I & II Australia This section provides information on labeling requirements and the label approval process. For information regarding this section, kindly reach out to our dedicate...

      5. Claim Requirements

      Medical Devices Class I & II Australia This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes. 5.1 Overview of Claims...

      6. Registration Processes

      Medical Devices Class I & II Australia This section provides information on any product notification or registration and manufacturing site registration processes. 6.1 Product Notification Variation to an...

      Appendix 1: Essential Principles – Schedule 1 – Parts 1 & 2

      Medical Devices Class I & II Australia

      Appendix 2: Medical Devices Essential Principles Checklist

      Medical Devices Class I & II Australia This form, when completed, will be classified as ' For official use only '. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <...