Category: 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

An Overview of European Unique Device Identification System

November 29, 2019
Medical Device

The Medical Device Regulations (EU 2017/745, EU 2017/746) introduce the Unique Device Identification (UDI) system to unambiguously identify medical devices within the global supply chain. The main...

Medical Device Post Market Surveillance

November 27, 2019
Medical Device

The post-market surveillance (PMS) systems that monitor medical device safety after launch reduce both costs and demands on resources and increase product safety and performance. Before bringing medical...

Why is Medical Technology Getting Shrouded by the Fear of Cybersecurity Issues?

November 22, 2019
Medical Device

Cybersecurity threats top the list when it comes to imminent dangers surrounding the healthcare industry. Every technologically driven device has a high chance of security breach and the main reason...

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 device, FDA medical device, Labeling, Medical Device

USA: FDA Drafts Guidance on Patient Engagement in Device Trials

September 27, 2019
Medical Device

The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers should engage patients when designing medical devices. This Draft Guidance is Intended...