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MALAYSIA: Harmonised Classification of Medical Device in ASEAN –January/February 2024

MALAYSIA: Harmonised Classification of Medical Device in ASEAN –January/February 2024

  • 2024-01-26 05:03:01

The Medical Device Authority (MDA) published Second edition Guidance Document, on “Guidance on Harmonised Classification of Medical Device in ASEAN”, on December 12, 2023. This guidance document provides the harmonised list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/ purpose as claimed by the manufacturer.

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SINGAPORE: HSA IS RECOGNIZED BY WHO AS STRINGENT REGULATORY AUTHORITY (SRA) FOR CLASS C AND D IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVD) - JULY/AUGUST 2023

SINGAPORE: HSA IS RECOGNIZED BY WHO AS STRINGENT REGULATORY AUTHORITY (SRA) FOR CLASS C AND D IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVD) - JULY/AUGUST 2023

  • 2023-07-21 02:32:25

Singapore's Health Science Authority (HSA) is pleased to announce their status as a recognized Stringent Regulatory Authority (SRA) for Class C and D IVD by WHO. The SRA status means high-risk IVD products registered with HSA might obtain faster evaluation through WHO prequalification assessment, enabling manufacturers accelerated access to global markets.

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MALAYSIA: MDA Announced the Second Edition on Classification of Rehabilitation, Physiotherapy and Speech Therapy Devices – April/May 2023

MALAYSIA: MDA Announced the Second Edition on Classification of Rehabilitation, Physiotherapy and Speech Therapy Devices – April/May 2023

  • 2023-04-25 01:40:47

The MDA published the Second Edition Guidance Document, “Classification Of Rehabilitation, Physiotherapy And Speech Therapy Device” (MDA/GD/0061), on March 08, 2023. This document is directed to give manufacturers and authorized representatives (AR) an appropriate guideline on the classification of rehabilitation, physiotherapy, and speech therapy products. This guidance document classifies a number of products used for rehabilitation, physiotherapy, and speech therapy as medical devices or non-medical devices respectively, based on the manufacturer's stated intended purpose.

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PHILIPPINES: PFDA Released FDA Circular No. 2021-002-C Further Extending the Application Period for CMDN for Class B, C, and D Medical Devices – April/May 2023

PHILIPPINES: PFDA Released FDA Circular No. 2021-002-C Further Extending the Application Period for CMDN for Class B, C, and D Medical Devices – April/May 2023

  • 2023-04-24 09:37:45

On March 31, 2023, PFDA has once again extended the application period for one more year for medical device products that were previously considered non-registrable, which currently fall under AMDD risk class B-D. PFDA cites the risk of disrupting the supply chain that may negatively impact the quality of the healthcare system in the country.

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USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

  • 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

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