Arab Health 2025
Arab Health 2025 is one of the world’s largest healthcare exhibitions. It brings together industry leaders, innovators, and regulatory experts
... Read more January 15, 2025
[searchwp_form id=1]
[blog_list]
What Are FDA Medical Device Classes?
Understanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing
... Read more December 17, 2024
How to Prepare for an FDA 510(k) Pre-Submission
Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new
... Read more November 15, 2024
Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices
The process of bringing medical devices to market in the United States involves stringent regulations imposed by the Food
... Read more November 2, 2023
How Manufacturers Can Stay Compliant With Canadian Medical Device Rules
https://youtu.be/E0E0dohMpC4 So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s talk
... Read more October 18, 2023
Navigating the Regulatory Seas: How Experts Ensure Your Medical Devices Set Sail Smoothly
Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy
... Read more September 29, 2023
What the Draft Guidance Means for MLMD Applications
*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the
... Read more September 11, 2023
Del Health Canada: Roles & responsibilities in protecting Canadians
Del Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices
... Read more August 23, 2023
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 August 13, 2023
Demystifying the Medical Device Regulatory Process: A guide for manufacturers
Navigating the complex medical device regulatory process can often feel like decoding a cryptic language. Manufacturers grapple with an intricate
... Read more August 10, 2023
Decoding the Jargon: Medical Device approvals 510(K) V.S. PMA differences & process
Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the
... Read more July 20, 2023
What you should know about FDA Approvals for Drugs & Medical Devices
Introduction: FDA approvals can be a complex process, but understanding its important steps can give you insight into how drugs
... Read more March 27, 2023
How to comply with Health Canada Regulations for Medical Devices?
Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s
... Read more March 22, 2023
Health Canada Medical Device License Renewals (MDL or MDEL) in 2023
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read more March 22, 2023
Understanding the Costs of MDL and MDEL Approvals
The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the
... Read more March 20, 2023
FDA Fees for Medical Device Establishment Registration in 2023
The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023
... Read more March 16, 2023
How to Choose the Right Importer: 5 Essential Tips
Looking for a quality import service can be a daunting task, but with the right advice and tips, you can
... Read more March 13, 2023
Understanding Class I Medical Devices Approval With Health Canada
What are Class 1 Medical Devices? Class 1 medical devices are the lowest risk category of medical devices, as they
... Read more March 8, 2023
MDR Amendments COVID-19 Medical Devices Importing & Sales
Background: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose, treat,
... Read more March 7, 2023
How to Navigate Regulatory Requirements for Class III Medical Devices
Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes
... Read more February 7, 2023
Clearing Regulatory Hurdles with a 510K Premarket Notification
Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the
... Read more January 23, 2023
Explore Health Canada’s 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. Medical
... Read more December 8, 2022
Understanding MDALL/MDEL & How It Transforms Your Business (MDL, MDALL, MDEL Listing)
Navigating medical device regulations set by Health Canada can be challenging. However, knowing the correct classification of your medical device
... Read more November 16, 2022
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 Licence
... Read more November 15, 2022
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 November 1, 2022
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
... Read more October 5, 2022
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.
... Read more September 15, 2022
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 April 29, 2022
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 March 11, 2022
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 March 8, 2022
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 February 9, 2022
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 February 5, 2022
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 October 28, 2021
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 October 11, 2021
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 September 14, 2021
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 August 20, 2021
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 July 16, 2021
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 July 2, 2021
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 June 15, 2021
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 December 15, 2020
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 September 13, 2020
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 January 20, 2020