Blog
Clearing Regulatory Hurdles with a 510K Premarket Notification
Submitting a 510 K Premarket Notification is an essential step in the process of getting medical devices approved by
... Read more Dillon Dubois January 23, 2023
Blog
Health Canada Medical Device Regulations (MDL, MDEL, SaMD)
Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients.
... Read more Dillon Dubois December 8, 2022
Blog
Canadian Medical Device Classification (MDALL, MDL & MDEL Listing)
How Medical Devices are Classified in Canada Regulatory Classification Basics for your Medical Device: There are certain rules that apply
... Read more Dillon Dubois November 16, 2022
Blog
Medical Device License (MDL MDEL SaMD) Under the Microscope
The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device
... Read more Dillon Dubois November 15, 2022
News
Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023
The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
... Read more Dillon Dubois November 1, 2022
Blog
Inside Scoop MDL VS MDEL & SAMD: Medical Device License Unlocked
The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical devices.
... Read more Dillon Dubois October 5, 2022
Blog
How Does FDA Classify Software As A Medical Device (SaMD)?
Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. The
... Read more Dillon Dubois September 15, 2022
Blog
FDA Facility Registration & Renewals (FDA Medical Device, Food & Drugs)
Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
... Read more Dillon Dubois September 13, 2022
News
EUA FDA Transition Plan for Medical Devices in 2022
In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
... Read more Femi Morakinyo April 29, 2022
News
Health Canada’s Annual Adjustment of Fees for Drugs & Medical Devices
On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices
... Read more Jessica Koves March 11, 2022
News
Interim Order No. 3 The Sale of Medical Devices for COVID-19 use
Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim
... Read more Dhreeti Kapoor March 8, 2022
Blog
Top 10 Fruitful Medical Device Development Principles
Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
... Read more Kalpna Mistry February 9, 2022
News
Your Health Canada eMCE Update For 2022
Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification
... Read more Femi Morakinyo February 5, 2022
Blog
Medical Device License Renewals (MDL or MDEL Canada) in 2022!
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read more Jessica Koves November 25, 2021
Blog
What You Need to Know – Software as a Medical Device (SaMD)
The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes
... Read more Jessica Koves October 28, 2021
News
US Establishment Registration Renewals
It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
... Read more Kalpna Mistry October 11, 2021
News
Public Consultation on Medical Devices Unique Device Identifier Initiative
On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
... Read more Kalpna Mistry September 14, 2021
Blog
MDSAP: What Is It and How Does It Apply to my Medical Device?
Who Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires
... Read more Andrew Parshad August 20, 2021
News
Public Consultation on Medical Devices Clinical Trials Modernization Initiative
Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
... Read more Andrew Parshad July 16, 2021
News
Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements
Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements On May 27, 2021 Health Canada
... Read more Andrew Parshad July 2, 2021
News
Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19
As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
... Read more Andrew Parshad June 15, 2021
Blog
Ensuring Predictability for Interim Orders Relating to COVID-19
Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is
... Read more Kalpna Mistry December 15, 2020
Blog
Regulatory Considerations for Non-Medical Masks or Face Coverings
Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings,
... Read more Kalpna Mistry September 13, 2020
Blog
Illegal Marketing of Drugs and Medical Devices in Canada
Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and
... Read more Quality Smart Solutions January 20, 2020