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Malaysia MDA Med Dev Guidance: Guide for CABs and Medical Device Establishments
The Medical Device Authority (MDA) of Malaysia has released two important guidance documents, " Guide for Conformity Assessment Bodies...

Sharan Murugan
Apr 13 min read
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TGA: Australian Regulatory Guidelines for Medical Devices (ARGMD)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) , issued by the Therapeutic Goods Administration (TGA), provide a...

Sharan Murugan
Dec 15, 20242 min read
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MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...

Sharan Murugan
Jan 18, 20242 min read
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Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form
Recently on 27th June, 2023 Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...

Sharan Murugan
Jul 2, 20232 min read
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