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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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AUSTRALIA:  Auditing of Medical Device Applications, including IVD Medical Devices – February, 2022

AUSTRALIA: Auditing of Medical Device Applications, including IVD Medical Devices – February, 2022

  • 2022-02-18 07:40:24

Application audit may be conducted during the procedure of inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG). In some applications, audit may be selective under the legislation, however, others may be selected for an audit at the discretion of the delegate. Here we list out the devices that require mandatory auditing under Regulation 5.3. To conclude, a summarised view of the audit process will be provided.

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AUSTRALIA: Introducing IVD medical devices in the ARTG – June, 2021

AUSTRALIA: Introducing IVD medical devices in the ARTG – June, 2021

  • 2021-06-25 10:40:40

Medical devices cannot generally be imported, supplied in, or exported from Australia unless they are included in the ARTG (Australian Register of Therapeutic Goods. Only an Australian sponsor can apply to include an IVD (In Vitro Diagnostics) in the ARTG. TGA has now issued requirements to be fulfilled in order to include an IVD in the ARTG.

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