Regulatory Affairs Professionals Society

MDCG updates guidance on device classification, EMDN, and supply disruptions

The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the ...
MedTech Dive

CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices

The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class ...
Becker's Hospital Review

FDA cuts 8 software functions from medical device classification

The FDA is excluding eight software functions that were previously classified as medical device status under the 21st Century Cures Act. The FDA released the new provisions in an April 19 document in ...
Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...
RAPS

TGA Proposes 5 Medical Device Classifications in Line With EU MDR

In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR).
Healio

FDA releases final rule on classification, reclassification of medical devices

Please provide your email address to receive an email when new articles are posted on . The FDA issued a final rule that implements modifications made by the FDA Safety and Innovation Act, as well as ...
The National Law Review

CFDA Issues New Classification Catalogue for Medical Devices In China

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Business Wire

Medical Device Market Outlook Report 2025-2030: Aging Demographic in Developing Countries Is Driving Major Growth, While Wearable Healthcare Device Accelerates Globally ...

DUBLIN--(BUSINESS WIRE)--The "Medical Device Market, by Device Type, Function, Durability, Therapeutic Segment, Risk Classification, Manufacture Method, Delivery/Acquisition, Operational Support Model ...
Nasdaq

AnPac Bio Class III Medical Device Passes Extensive NMPA Registration Tests and Will Start Clinical Trial in Q1, 2022

PHILADELPHIA, Jan. 04, 2022 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a US and China-based biotechnology company focused on early cancer ...