Supporting the Development of Regenerative Medical Products for Rare Diseases
Japan, the Orphan Drug Designation (ODD) system is designed to promote the development of treatments for rare diseases, including regenerative medical products. Regenerative medical products, which encompass therapies aimed at repairing or replacing damaged tissues or organs, can qualify for ODD if they meet specific criteria.
Japan’s Orphan Drug Designation System: Advancing Medical Technologies for Rare Diseases
In Japan, the Orphan Drug Designation (ODD) system is a pivotal regulatory framework designed to encourage the development of medical devices targeting rare diseases. This initiative aims to address unmet medical needs by providing various incentives to manufacturers, ensuring that patients with rare conditions have access to essential medical technologies.
IMDRF Releases Key Guidance Documents for Medical Device Software
The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.
EMA Launches Early Scientific Advice Program for High-Risk Medical Devices
The European Medicines Agency (EMA) has launched a new Early Scientific Advice (ESA) program aimed at supporting the development of high-risk medical devices. This initiative seeks to provide manufacturers with timely regulatory guidance, ensuring that innovative medical technologies meet the necessary safety and efficacy standards before reaching the market.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Brazil’s Anvisa’s Medical Devices for In Vitro Diagnosis Regulation (RDC 830/2023) comes into force in June 2024
Anvisa’s RDC 830/2023 Regulating Medical Devices for In Vitro Diagnosis comes into force in June 2024
Overview of Medical Device Anvisa Regulations in Brazil
The most important regulation for Medical Devices in Brazil is RDC 751/2022, which provides for the risk classification, notification and registration regimes, labeling requirements, and instructions for use of medical devices.
Brazil’s Anvisa Organization of the Common Technical Document (CTD) Copy
Organization of the Common Technical Document (CTD) outlined by Brazil’s Anvisa Regulations for format of Pharmaceutical dossiers.
Brazil’s Anvisa Organization of the Common Technical Document (CTD)
Organization of the Common Technical Document (CTD) outlined by Brazil’s Anvisa Regulations for format of Pharmaceutical dossiers.
How are Heath Products Regulated with Brazil’s ANVISA?
Product registration at Anvisa is the last stage of regularization and is where the product will be tested to ensure product safety and efficiency.
Anvisa: How can I get a CADIFA anyways?
Blog explains the process and How can CADIFA’s are issued and approved by Brazil’s Anvisa. A CADIFA is the Term used by Anvisa to describe an approved DMF for an API in Brazil.
Brazil’s Anvisa Classification of Personal Hygiene Products, Cosmetics & Perfumes
Understand Brazil’s Anvisa criteria for the classification of personal hygiene products, cosmetics, and perfumes.