• 2025-02-21 05:10:50

The Therapeutic Goods Administration (TGA) has updated its application audit guidance for medical devices and in-vitro diagnostics (IVDs), to streamline regulatory processes and focus on high-risk devices. Additionally, the transition from the EU In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) introduces stricter requirements and extended transition periods for compliance. Medical device manufacturers must ensure thorough documentation and timely submissions to meet these evolving standards.

• 2023-07-21 03:49:06

The Therapeutic Goods Administration (TGA) will no longer accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices after May 26, 2023. Only approved IVD medical devices supported by ISO 13485 certificates will remain valid until the certificate expires.

• 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.

• 2023-03-27 08:27:31

Thai FDA announces 'Thailand FDA - WHO Collaborative Registration Procedure (CRP) for in vitro diagnostics (IVDs)', an expedited medical device registration program aimed at reducing the time required for manufacturers and importers to register their products. The program officially commenced on December 28, 2022, onward.

• 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).

• 2022-10-25 06:47:43

MDCG 2022-14 is aimed to propose solutions to improve the efficiency of application of the regulatory requirements, rather than reducing, avoiding or removing requirements, in particular in relation to safety.

• 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.

• 2021-08-26 12:58:20

In July, MOH released two Official Dispatches as guidance on registration routes and document preparation to import SARS-CoV-2 IVD medical devices and biologicals, especially SASR-CoV-2 Antigen Rapid Test Kit (RTK).

• 2021-08-02 04:21:25

In December 2020, MDA published the 2nd edition of the guidance document on the classification system of in-vitro diagnostic (IVD) medical devices. Compared to the 1st edition, this has a more solid and structured explanation for each classification.

• 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.