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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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AUSTRALIA: Use of Market Authorisation Evidence from Comparable Overseas Regulators / Assessment Bodies for Medical Devices (including IVDs) - October/November 2022

AUSTRALIA: Use of Market Authorisation Evidence from Comparable Overseas Regulators / Assessment Bodies for Medical Devices (including IVDs) - October/November 2022

  • 2022-10-25 07:32:01

In Australia, the “Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)” and the “Reduction of Assessment Fees for Medical Devices Guideline”, both outline specific situations in which the assessment procedures and the assessment costs for medical devices may be reduced.
The guideline provides details on the criteria and the eligibility for TGA to determine whether the process can be reduced for application audit assessments and conformity assessments involving medical devices (including IVDs).

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MDR: MDCG 2022-12 - Harmonized Administrative Practices and Alternative Technical Solutions until Eudamed is Fully Functional (for IVDR) – August 2022

MDR: MDCG 2022-12 - Harmonized Administrative Practices and Alternative Technical Solutions until Eudamed is Fully Functional (for IVDR) – August 2022

  • 2022-08-31 05:37:18

MDCG 2022-12 provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. This guidance intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.

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