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USA: US Medical Device Classification Update: Intravascular Bleed Monitor & The Non-Implanted Electrical Stimulation Devices – July, 2022

USA: US Medical Device Classification Update: Intravascular Bleed Monitor & The Non-Implanted Electrical Stimulation Devices – July, 2022

  • 2022-07-26 11:26:52

According to the De Novo Classification request from the respective manufacturers, the US FDA reviewed the request for the following devices, Intravascular Bleed Monitor and Non-Implanted Electrical Stimulation Devices for Management of Premature Ejaculation. As a result, both types of products are now classified as Class II products rather than belong to products of Class III.

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MALAYSIA: New Guideline Document MDA/GL/08: Re-Registration Of Registered Medical Devices – July 2022

MALAYSIA: New Guideline Document MDA/GL/08: Re-Registration Of Registered Medical Devices – July 2022

  • 2022-07-26 11:19:48

The Medical Device Authority (MDA) published a guideline document to provide information and explanation to establishments on how to submit a re-registration of registered medical device applications in Malaysia. The document prescribes the requirements for re-registration of registered medical devices for medical device registration applications that are about to expire or have already expired.

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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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