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AUSTRALIA: Regulatory changes for software-based medical device

AUSTRALIA: Regulatory changes for software-based medical device

  • 2021-03-22 01:22:59

The Medical Device Branch (MDB) of the Health Sciences Authority (HSA) has released a draft document entitled “Regulatory changes for software-based medical devices” and changes effective from 25 February 2021.
The purpose of the guideline is to update the classification of software-based medical devices according to the risks of harm from software and outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

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QT ANALYSIS: Rehabilitation medical device market and registration requirements in Asia

QT ANALYSIS: Rehabilitation medical device market and registration requirements in Asia

  • 2021-02-19 09:51:48

Asia’s elderly population is set to see tremendous growth, coupled with a rise in various geriatric and non-communicable health issues. To tackle these problems, rehabilitative and assistive medical devices market show great potential to become a major medical device segment in various Asia countries. In this issue of QT Analysis, we look at the market size for rehabilitative and assistive medical device and their registration requirements in some major Asian countries.

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 PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

  • 2021-02-22 01:59:49

Recently, PFDA has shared two key guidance to the industry and stakeholders. FDAC 2020-001A updates the list of registrable medical devices while FDAC 2021-002 discusses the full implementation of medical device registration as per AO 2018-0002. The new guidance will have immediate impact the regulatory requirement for medical devices prior importing and selling in Philippines.

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