• 2024-06-19 09:02:05

This guidance outlines safety reporting procedures, including prompt reporting of serious adverse events (SAEs) and device deficiencies with causal relationships, for in vitro diagnostic medical devices (IVDs) in performance studies.

• 2024-06-19 06:31:24

Starting 13 May 2024, Hong Kong Medical Device Division has excluded non-clinical devices from Medical Device Administrative Control System’s scope. Custom-made medical devices have also been excluded from this scope since 2 April 2024, and marketing approvals from Health Sciences Authority - Singapore has been accepted to support listing applications.

• 2024-06-19 06:08:37

The Indonesian Ministry of Health recently issued guidelines to regulate the use of Medical Devices and Household Health Supplies through electronic systems. These guidelines, signed on 5 April 2024, offer crucial information for business actors, manufacturers, and distributors in the healthcare sector seeking to market their products in electronic systems.

• 2024-05-02 01:55:12

Join our FREE webinar on ASEAN Regulatory Updates & Brazil's Medical Device Regulations. Learn how to stay compliant and enter the Brazil market! Sign up today!

• 2024-06-27 05:11:25

This article provides a comprehensive guide on TGA sponsors, a critical partner for medical device companies seeking to enter the Australian market. It explains the role of the Therapeutic Goods Administration (TGA) and how a TGA sponsor acts as a liaison, navigating the complex regulatory process to ensure compliance.

• 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.

• 2024-05-08 01:49:59

In April 2024, Hong Kong Medical Device Division has introduced the new Medical Device Information System, a one-stop e-service that allows online Medical Device Administrative Control System listing applications for medical devices and traders. It is highly recommended to familiarize with the new e-services, as we transition out of paper-based submissions.