Australia and Oceania
The institution that oversees medical devices in Australia is the Therapeutic Goods Administration (TGA). The TGA has established the Australian Regulatory Guidelines for Medical Devices (ARGMD), which closely resembles the regulations put into place by the European...
North America
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II, and...
RegDesk News/Info
“So is RegDesk essentially a regulatory consulting firm?” Questions like these haunt everyone on the ours team. More often than not, inquisitors are quick to slap the “consulting firm” label onto the RegDesk name when attempting to categorize the company. But the...
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...
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