• 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.

• 2024-06-20 05:24:57

This guidance outlines the requirements for sponsors submitting applications for clinical investigations and supports sponsors in developing the Investigator's Brochure.

• 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.

• 2024-05-08 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 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.

• 2024-04-08 08:12:16

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

• 2024-03-01 08:34:44

This guidance clarifies the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices

• 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 06:51:35

This guidance provides demonstration of equivalence for products without an intended medical purpose listed in Annex XVI of the MDR.