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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:  MDA Introduces New Guidance Document MDA/GD/0061: Classification of Rehabilitation, Physiotherapy And Speech Therapy Device – June, 2022

MALAYSIA: MDA Introduces New Guidance Document MDA/GD/0061: Classification of Rehabilitation, Physiotherapy And Speech Therapy Device – June, 2022

  • 2022-06-29 02:17:39

In April 2020, the Medical Device Authority (MDA) has issued a new Guidance Document regarding the classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices (MDA/GD/0061). This document guides the manufacturers and authorised representatives on classifying rehabilitation, physiotherapy, and speech therapy as medical devices.

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USA: Low-Risk Novel Products Can Avoid Automatic Class III Designation from US FDA – March, 2022

USA: Low-Risk Novel Products Can Avoid Automatic Class III Designation from US FDA – March, 2022

  • 2022-03-25 11:58:47

The US Food and Drug Administration (FDA) has updated several regulations affecting De Novo classification of novel medical devices. The main purpose is to present an objective and balance for the scientific evidence to be the foundation to grant a De Novo request. Also, the De Novo products will serve as future predicate devices for prospective 510(k) registration applications to improve and extend the existing 510(k) database.

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AUSTRALIA: Information for Medical Practitioners on Up-Classification of Surgical Mesh Devices – March 2022

AUSTRALIA: Information for Medical Practitioners on Up-Classification of Surgical Mesh Devices – March 2022

  • 2022-03-25 10:23:24

In December 2018, TGA has announced that there will be an adjustment of Surgical Mesh Devices to transform from medium risk (Class IIb) to high-risk devices (Class III), in order to meet the highest levels of safety, quality and clinical performance.
Sponsors were given three years to comply with the changes, and from 1 December 2021 onwards TGA has already commenced on cancelling surgical mesh devices in the ARTG as Class IIb entries, who do not have obtained an appropriate conformity assessment certificate for Class III devices prior to the set deadline, or within six months of the conformity assessment certificate for the Class III device being issued.
TGA has listed out 3 different tables, categorising meshes that are eligible for transition, approved surgical mesh devices, and existing Class III surgical mesh devices. This is to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1st December 2021, and to provide alternative sources of supply.

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