• 2025-02-21 05:38:28

Qualtech hosted a webinar providing key insights into the evolving European medical device regulations. The discussion covered essential updates, including the MDR transition period extension, Article 10A supply notification requirements, the gradual rollout of EUDAMED, the implications of the European AI Act, and regulatory changes in the UK and Switzerland. Attendees gained valuable guidance on compliance strategies and proactive measures to navigate these regulatory shifts.

• 2025-01-20 06:54:39

Register our FREE Webinar on 2025 Updates & Forecast for European Medical Device Regulations. Keep your medical device compliance in Europe up-to-date!

• 2025-01-22 07:36:15

The Therapeutic Goods Administration (TGA) has introduced the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC) to streamline and enhance the recall processes for therapeutic goods in Australia. By reducing recall categories, simplifying procedural steps, and improving communication, the PRAC aims to foster efficiency and clarity for manufacturers and regulatory consultants. With implementation set for March 2025, stakeholders are encouraged to prepare for these reforms to ensure compliance and contribute to a safer therapeutic goods landscape.

• 2025-01-22 07:16:29

This guidance provides detailed instructions on assigning Master Unique Device Identification Device Identifiers (Master UDI-DIs) to contact lenses.

• 2025-01-22 07:00:59

This guidance provides instructions for sponsors on submitting clinical investigation reports and their summaries to Member States' competent authorities when EUDAMED is not fully functional.

• 2025-01-22 06:50:55

This document offers a detailed Q&A guide on the progressive implementation of Eudamed, focusing on the gradual roll-out of Eudamed, obligations related to supply interruptions or discontinuations, and transitional provisions for certain in vitro diagnostic medical devices.

• 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.

• 2024-11-05 02:13:00

The Therapeutic Goods Administration (TGA) has issued a reminder to manufacturers and marketers to comply with advertising rules for therapeutic goods, particularly on social media, following a rise in non-compliance cases. Key rules include ensuring ads are truthful, promoting only registered goods, adhering to endorsement guidelines, avoiding unapproved uses, clearly presenting risks and health warnings, and ensuring influencer content meets regulatory standards.

• 2024-09-17 05:23:25

This guidance offers instructions on the clinical evaluation of orphan devices under the MDR.

• 2024-07-30 05:11:43

The Therapeutic Goods Administration (TGA) of Australia recently released a guidance document to clarify the distinction between cosmetics and therapeutic goods. This distinction is crucial as it determines the regulatory requirements that apply to a product.