Category: Standards

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

Registration of Drug-device Combination Products

October 8, 2021
Standards

NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products With the view to strengthening registration management of drug-device combination products, in accordance with...

combinationproduct, drug, medicaldevice, NMPA, registrationofdrug, registrationondevice

Color Additive Petitions

September 24, 2021
Standards

FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices Food and Drug Administration (FDA) provides guidance for the...

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Infusion Pumps Safety Assurance

September 24, 2021
Standards

The US Food and Drug Administration (FDA)’s guidance, entitled “Infusion Pumps Total Product Life Cycle” provides assistance to industry in preparing premarket submissions for infusion pumps and to...

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Safety and Performance (SSP) of Class C and D IVDs

September 1, 2021
Standards

The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other...

SaMD Regulatory Landscape in the US and Europe

August 13, 2021
Standards

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis...

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