• 2025-04-11 02:14:00

Join Qualtech Consulting Corporation on April 24th for an insightful webinar, "Navigating India’s Medical Device Regulatory Landscape: A Comprehensive Guide." This session is tailored for both newcomers and seasoned professionals seeking to demystify India's evolving medical device approval process

• 2024-12-16 08:47:55

This guidance clarifies the regulatory framework for the use of EtO in sterilizing medical devices and in vitro diagnostic medical devices.

• 2024-10-08 05:56:39

Join Qualtech's Webinar on India's Medical Device Market and Regulations

• 2024-09-17 06:17:58

Australia's TGA has issued new guidelines for exempt medical devices, clarifying that while not requiring ARTG registration, these products still face strict oversight. Manufacturers must adhere to reporting, recall, advertising, and quality standards to ensure patient safety. Non-compliance can result in penalties.

• 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!

• 2024-05-07 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.

• 2024-04-08 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.

• 2024-01-26 03:40:25

The FDA has issued a draft guidance to clarify how it reviews real-world data, ensuring its quality for generating evidence that can inform regulatory decisions on medical devices.

• 2023-12-28 09:01:53

In this latest edition, we navigate the evolving landscape of medical device regulations, marked by progress and heightened vigilance. The improvement of technology and healthcare is making things better for patients, but it also needs careful supervision. Over the past year, global regulatory bodies have demonstrated adaptability, reinforcing frameworks to manage medical device registrations effectively.

This edition offers a concise analysis of the latest mandates, impending updates, and pivotal shifts for 2024, addressing the exchange between technological innovation and the mission to ensure global safety and efficacy.

• 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.