• 2024-05-08 03:23:54

The TGA is streamlining therapeutic goods recalls with phase two of its Recall Reforms. This initiative aims to achieve a dual benefit: reducing the regulatory burden on sponsors and strengthening public safety.

Sponsors will experience a simplified and more flexible reporting process, while the "Early Advice" program, allowing proactive communication with the TGA, will see enhanced communication protocols.

• 2024-05-08 03:10:55

To promote consistent advertising practices across the medical industry, the TGA updated its guidelines for promoting cosmetic injectables.

• 2024-05-08 03:00:06

CMDE has issued a new notice, supplementing previous recommendations with updated clinical evaluation paths for specific medical devices, aiming to guide registration applicants effectively in navigating the regulatory process.

• 2024-05-08 02:32:34

This guidance provides detailed instructions to assist sponsors in preparing plans that fulfill regulatory expectations and streamline the assessment process by competent authorities.

• 2024-05-07 09:28:59

The Medical Device Authority (MDA) announced the cancellation of the Circular exempting the registration of Covid-19 Test Kits from the Compliance Assessment Process by the Compliance Assessment Body (CAB). The MDA Circular No. 1/2022 states the exemption of the compliance assessment process by the Compliance Assessment Body (CAB) under Section 7 of the Medical Devices Act 2012 (Act 737) for the registration of COVID-19 test kits under Section 5 of Act 737 either for self-use or for professional use.

• 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.

• 2024-04-08 08:22:03

This article explores Qualtech's strategy to achieve this feat, including navigating China's complex regulatory framework and leveraging an experienced medical writing team. The outcome is a faster market entry for Qualtech's product, offering a significant advantage in the lucrative Chinese market.

• 2024-04-08 08:12:16

This guidance aims to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices.

• 2024-04-08 07:44:40

Last February 19, 2024, Hong Kong Medical Device Division has published a Supplementary Information Sheet (MD111) to strengthen procurement strategy with the Hospital Authority (HA). HA procured devices seeking to be listed under Medical Device Administrative Control System can provide supplementary information through this form for regulatory authorities’ consideration.