• 2024-12-16 09:17:34

The updated Therapeutic Goods regulations in Australia, effective October 19, 2024, introduce streamlined documentation for medical devices assessed by the US FDA. By aligning with international standards, the changes simplify compliance for Class IIa and Class III devices, reducing burdens while ensuring safety and quality, offering manufacturers faster market access.

• 2024-11-04 08:50:30

Thai FDA introduced new guidelines for handling the registration of medical devices under Notified (Class 2 & 3) and Licensed (Class 4) Medical Device. Thai FDA permitted referencing of previously approved dossiers when applying for brand name changes ("Refer") and for the transfer of medical device licenses between medical device establishment ("Transfer"). This move aimed to streamline the regulatory process, reduce redundant dossier reviews, and simplify licensing in Thailand's medical device sector.

• 2024-09-17 03:42:57

The Expedited Approval Scheme for Medical Device Listing Applications has been expanded to include Class B/C/D In Vitro Diagnostic Medical Devices. Eligibility criteria remain unchanged, while some additional regulatory agencies have been recognized. Applications must be submitted through Medical Device Information System and refers to both GN-02 and GN-06.

• 2024-06-20 06:13:07

The TGA's new "Examples of Boundary and Combination Products" clarifies how to classify complex goods that blur the lines between medicines, medical devices, and biologicals. This list includes common products like injectable fillers and contact lens solutions.

• 2024-05-07 09:12:46

The Food and Drug Administration (FDA) has recently issued Circular No. 2024-003, which extends the regulatory flexibility and application of CMDN for medical devices under Class B, C, and D that are not listed as registrable medical devices in FDA Circular No. 2020-001-A.

• 2024-05-07 08:47:38

Thai FDA has replaced its previous criteria for evaluating medical devices via expedited routes with new guidelines published in 2024. The aim is to streamline the evaluation process for Licensed and Notified medical devices (Class 2,3,4) while ensuring quality, efficiency, and safety. The announcement outlines criteria, documents required, and regulatory procedures for the Concise Evaluation and Reliance Program routes under expedited route review.

• 2024-01-26 06:58:53

This guidance explains the qualification and classification of products without an intended medical purpose listed in Annex XVI of the MDR.

• 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.

• 2023-10-20 08:44:59

NMPA adjusted the "Medical Device Classification Catalog", involving 58 Medical Device Classifications. Among the important adjustments are strengthening the management of soft tissue ultrasound heads and breast rotary cutting products.

• 2023-10-20 06:59:35

PMDA revised Technical Standards for some of the class III generic devices. The notices were issued on August 31.