Author: Nikita Angane

FDA released a guidance document on Monday in the form of a question and answer format to help the industry understand the implications of the pandemic on their pre-market submissions made to the FDA. As per this guidance, FDA says the...

FDA has already issued temporary policies on how it regulates PPEs and various other covid-19 essential medical supplies during this public health emergency. On May 21,2020, FDA released another temporary policy that allows manufacturers of devices cleared under a Pre-Market...

The EU commission released a guidance document this week that explains the commission’s policies for transitioning of CE certificates for combination products and for devices manufactured using animal tissues under the medical device regulations. Under the Medical Device Directives and the...

In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the application of the EU Medical Device Regulations, which were set to go into effect in May 2020 by a year. This also means...

In an effort to accelerate the production of tests for COVID-19, FDA released a new guidance document that will allow for clinical laboratories and commercial manufacturers to accelerate the development of COVID-19 tests. In this guidance document, FDA outlines its...

COVID-19 has severely disrupted the medical device supply chain. Device manufacturers are typically not required to report shortages of device supplies or interruptions in the production to the FDA. However, in light of the pandemic situation, CDRH requires that device...

In Europe, medical devices are regulated under the Directive 93/42/EEC—the “Medical Devices Directive” (MDD) which is annulled by the Medical Devices Regulation (MDR) (EU) No. 2017/745, whereas Personal Protective Equipment is regulated under Regulation (EU) 2016/425 (the PPE regulation), which...

Just like every other nation, Australia has also taken several measures to respond to the global pandemic. To help prevent shortages of medical equipment and personal protective equipment, the Australian regulating authority- Therapeutic Goods Administration (TGA) has announced several exemptions...

Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the shortage of medical equipment and the PPEs, Health Canada relaxed their policies to let medical equipment and other necessary supplies...