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AUSTRALIA: Clinical Evidence Guidelines: Medical Devices – July 2022

AUSTRALIA: Clinical Evidence Guidelines: Medical Devices – July 2022

  • 2022-07-26 09:41:26

The TGA has released version 3.1 of its latest guideline for the clinical evidence for medical devices. The purpose of this guideline is to allow both industry and TGA to support sponsors and manufacturers to collect, compile and present clinical evidence under regulatory requirements as well as to inform on how TGA assesses clinical evidence.

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MALAYSIA: Circular Letter No 3 Year 2018: Recognition and Listing of Institute or Laboratory Which is Capable to Carrying Out Clinical Evidence or Performance Evaluation for the purpose of Conformity Assessment - July 2018

MALAYSIA: Circular Letter No 3 Year 2018: Recognition and Listing of Institute or Laboratory Which is Capable to Carrying Out Clinical Evidence or Performance Evaluation for the purpose of Conformity Assessment - July 2018

  • 2020-02-13 06:21:59

Medical devices to be registered in Malaysia must first undergo conformity assessment with a Conformity Assessment Body, to demonstrate its conformity to the requirements of medical device law. In regards to this, currently there are conformity assessment service with good quality and also comparable to global assessments or test carried out by local laboratories.

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