Tag: Medical Device

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Jan 2025

February 6, 2025
Medical Device

USA Guidance on Premarket Approval Application and Humanitarian Device Exemption Modular Review The guidance provides information on the Premarket Approval Application (PMA) and Humanitarian...

Device Approval, EU Regulations, FDA, Global Regulations, Healthcare Regulations, Innovation Healthcare, MDR2025, Medical Device, Medical Device Compliance, Medical Device Industry, Regulatory Affairs, Regulatory News, Regulatory Updates

Medical Device and Restricted Hazardous Substances

February 28, 2023
Medical Device

RoHS stands for Restriction of Hazardous Substances, and impacts the entire electronics industry and many electrical products as well. The original RoHS, also known as Directive 2002/95/EC, originated...

Medical Device, Restricted Hazardous Substances, RoHS, RoHS Certification, RoHS Testing

Guidance on Premarket Submission for Device Software Functions

November 12, 2021
Medical Device

The draft guidance is intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software...

FDA Medical Device clinical Regulations, fda submission guidance, guidance document pertain to device software functions, Guidance on premarket submission, Medical Device, software design specification medical device, software in a medical device

China’s CMDE Announces New Regulations on the Supervision and Administration of Customized Medical Devices for Clinical Trials

January 22, 2020
Medical Device

The Center of Medical Device Evolution (CMDE) of China has released a regulation (notification 53) that clarifies the requirements for the definition, listing, design, processing, usage, supervision...

China, Medical Device, Regulations

Labeling Requirements for Medical Devices

November 21, 2019
Medical Device

Labeling acquires a major part when it comes to ensuring the safety of those that are using it. The leading international standard ISO 13485:2016, pertaining to the quality systems of medical devices...

cosmetics, EU medical devic, FDA medical device, Labeling, Medical Device