Asia
Saudi Arabia’s Food and Drug Authority has published its final guidance on the new Medical Device National Registry (MDNR), a streamlined market authorization pathway for low-risk medical devices. This new market route is specifically for Class I non-sterile and...
Asia
For the last 70 years, only a handful of medical devices have been regulated in Pakistan under its Drug Act of 1976. In an attempt to control the quality of the devices being sold and used in the country, the Drug Regulatory Authority passed the Medical Device Rules...
North America
In recent years, the opioid epidemic has played a dominant role in the United States as opioids continue to be exploited. The National Institute on Drug Abuse states that more than 115 people die from opioid abuse every day. In May 2018, the specialty company US...
Consultant Post
Dealing with FDA deficiency letters doesn’t have to be hard, read on to find out how best to address your deficiencies.
North America
The difference between CLIA and FDA standards
#WednesdayWebinar Join us for our upcoming webinar Global Regulatory Changes to Expect in 2025 January 22, 2025 at 10 AM ET
Register Now
