The FDA revised its guidance document ‘Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers’ which was originally released in June, to give device sponsors additional time in...
Part 2 of the Canadian Medical Devices Regulations under the Food and Drugs Act allows for health care professionals to request the use of custom-made and unlicensed medical devices on patients.1 To be eligible to receive this special access, the...
The EU regulators delayed implementation of the EU MDR by a year with its new date of application now being May 26th,2021. However, Article 59 of the EU MDR went into effect on April 24th,2020, and also encompasses the EU...
The European Commission published a new guidance document that clarifies certain requirements originally outlined in MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions.1 The new guidance clarifies the...
Health Canada released a notice for the stakeholders of the medical device and drug industry to help them understand the tenure of the interim orders released during the pandemic.1 Since March 2020, Health Canada released five interim orders each of which...
The US FDA introduced a new form of certificate referred to as the Certificate for Devices Not Exported from the US (CDNE). These certificates are for devices not manufactured in the US and hence are not eligible for export certificates...
The EU MDR and the IVDR layout the performance and safety requirements for medical devices and In-vitro diagnostics respectively in the EU. According to Article 8 of the EU MDR and the IVDR, manufacturers that comply with the harmonized standards...
Manufacturers that export FDA-regulated products such as drugs and medical devices from the US are oftentimes required to provide a certificate prepared by the FDA which confirms the product’s regulatory and marketing status.1 In most cases, the foreign regulatory body requires...
The Brexit has not only impacted Britain and the EU, it has made changes to the Northern Ireland region as well. As the UK will start implementing the UKCA mark, the Northern Ireland region will start using the UKNI mark...
The EUDAMED Actors module is all set to start accepting registrations from member states and economic operators from 1st December 2020. EUDAMED is a portal that consists of 6 modules and the Actors module serves as the establishment registration portal...