Author: Nikita Angane

Health Canada recently published SOR/2020-262 amending the Food and Drug Regulations and the Medical Devices Regulations (CMDR). The amendments under these regulations strengthen Health Canada’s ability to collect post-market safety information in support of Vanessa’s Law (Protecting Canadians from Unsafe...

January 12th is celebrated as National Pharmacist Day to recognize all the pharmacists across the nation. In addition to surgeons, nurses, and paramedics, this is another profession that contributes immensely to the health care industry. Historically, pharmacists only dispensed prescribed...

The Medical Device Single Audit Program covers the compliance requirements of the USA, Brazil, Japan, Canada, and Australia. Although this program does not cover the requirements of the EU, which is the EU MDR and IVDR, a guidance document released...

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...