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Medical Devices – USA/Europe Regulatory Updates round up – Oct 2021

November 5, 2021
Medical Device

EUROPE1. MDCG 2021-26 – Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This document presents questions and answers...

EU Medical Device clinical Requirements, Europe Regulatory Updates, FDA Medical Device clinical Regulations, medical device labeling requirements, Medical Devices, Regulatory Updates, USA Regulatory Updates

WHO Recommendations for screening and treatment to prevent cervical cancer

November 5, 2021
Diagnostics

Too many women worldwide – particularly the poorest women – continue to die from cervical cancer; a disease that is both preventable and treatable. In order to help countries make faster progress,...

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Medical Devices – Asia Regulatory Updates Roundup – Oct 2021

November 3, 2021
Medical Device

Philippines(FDA) 1.FDA Circular No.2021-0021: Guidelines on the Licensing of Retailers of Medical Devices in the PhilippinesThis Circular aims to: Specify the establishments classified as retailers...

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Guiding Principles for Good Machine Learning Practice

October 29, 2021
Standards

The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can...

artificial intelligence and machine learning, fda artificial intelligence, Guiding Principles for Good Machine Learning, Machine Learning-enabled medical devices, Medical Devices

ICH Guideline E8 (R1) on General Considerations for Clinical Studies

October 21, 2021
Standards

Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those...

Center for Drug Evaluation and Research, Clinical studies of medical interventions, ich e8 general considerations for clinical studies, ich e8 guidelines

Switch of the legal status of a medicinal product from prescription to non-prescription – Romania

October 18, 2021
Medical Device

Principles and procedures for a ‘switch’ of the legal status of a medicinal product from prescription to non-prescription – Romania Principles and procedures: • It is to the applicant to...

Medical product, Prescription to non-prescription, principles for a switch of the legal status, switch of the legal status