Name: Health Canada and FDA Regulatory Compliance Solutions
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FDA medical device submission checklist to avoid errors

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Avoid FDA Medical Device Submission Errors With These Tips

Avoid FDA medical device submission errors and improve your approval chances with these expert tips.

Quality Smart Solutions March 18, 2025

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Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices

This article explores the differences between these designations and provides insights into how to obtain the necessary licenses for medical devices.

Andrew Parshad November 2, 2023

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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

Andrew Parshad September 29, 2023

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Why is it crucial to avoid FDA Warning Letters for dietary supplements and health products?

As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory

Andrew Parshad September 27, 2023

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6 steps to earn your Medical Device Establishment License (MDEL)

In this blog, we discuss the benefits, challenges, steps, and opportunities a medical device establishment license can offer manufacturers and

Quality Smart Solutions June 19, 2023

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Class 2 Medical Devices: Unlocking compliance requirements

Medical devices play a crucial role in modern healthcare, providing patients with life-changing treatments and improving the quality of

Quality Smart Solutions June 1, 2023

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A complete guide to 510k submissions: Everything you should know

As a medical device manufacturer, getting your product to market can be a complex process with various regulatory requirements to

Quality Smart Solutions May 23, 2023

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The ultimate regulatory guide to importing products into Canada

https://youtu.be/mWaBQzsa1_M If you’re a business owner looking to expand your reach into the Canadian market, importing products may be a

Quality Smart Solutions May 17, 2023

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FDA Furls: How do they affect medical device manufacturers?

https://youtu.be/yvnTszySkgg If you’re in the medical device manufacturing business, you’re likely familiar with the FDA’s regulations, including FDA Furls. However,

Quality Smart Solutions April 25, 2023

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FDA Registration Renewals: FDA Increases Facility Enforcement

As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal

Quality Smart Solutions March 22, 2023

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5 Essential Tips for Choosing a Quality Import Service

Looking for a quality import service can be a daunting task, but with the right advice and tips, you can

Quality Smart Solutions March 13, 2023

Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements. Understand the Regulatory Requirements of Class 3 Medical Devices. Class 3 medical devices have the most stringent regulatory requirements when compared to other device classes. To ensure they meet the specific standards set by regulators, manufacturers must thoroughly understand what their obligations are and how to meet them. This includes understanding device labeling, conducting necessary preclinical tests, and designing appropriate clinical trials as well as obtaining marketing authorization from local and international agencies. With little room for error, a company must pay ample attention to meeting these strict regulations. Step-by-Step Guide for Regulatory Compliance Process. A step-by-step guide for Class 3 medical device manufacturers to prepare for and meet regulatory requirements is provided below: 1. Understand the local and international standards and regulations that apply to your product. 2. Perform risk assessments, identify hazards, and assess safety risks. 3. Develop appropriate device labeling information including instructions, warnings, indications, and contraindications. 4. Prepare preclinical tests related to the identified safety risks of the medical device. 5. Run clinical trials by applicable regulations and obtain relevant certification of efficacy, performance, or other features as necessary. 6. Submit marketing authorization applications to local or international agencies if required by applicable regulations or laws. 7. Develop post-marketing surveillance plans as may be needed going forward to ensure continued compliance with standards and regulations applicable to your device. Strategies to Reduce Cost and Time in Compliance Testing. There are strategies to reduce the cost and time associated with compliance testing. For example, the development of a standardized quality manual helps to streamline the process, by providing step-by-step protocols that must be met to achieve conformity with regulatory requirements. Leveraging tools like automated data collection can help bring costs down for conducting tests and checks, where testing has been pre-certified as meeting standard requirements. Additionally, engaging external compliance teams or consultants early in the process can help identify any potential problems quickly and provide advice on which steps are critical to addressing quality management issues. Assessing the Role of Third-Party Certifiers in Regulating these Devices. Third-party certifiers are an invaluable tool in the regulation of Class 3 medical devices. Not only do they allow manufacturers to have a comprehensive overview of the entire product development cycle and all its stages, but they also aid in certifying that requirements have been met as outlined by regulatory authorities. Additionally, they can provide valuable insights into which materials must be considered during the production process that may not necessarily be required by regulations, but would improve safety or efficacy. Ultimately, certification from third-party entities is an essential component for Class 3 medical devices to fully comply with applicable standards and regulations. Guidelines for manufacturers for Managing Risk and Adverse Events. The risk of adverse events is an ever-present reality for medical device manufacturers. Therefore, it is important to have a robust management system in place for risk and adverse event assessment, reporting, and monitoring to minimize the potential impact these may have on safety and efficacy. Manufacturers should clearly define criteria within product development plans to ensure appropriate assessments are taken during each product’s entire life cycle. This includes a systematic approach to suspending, withdrawing, or replacing devices deemed unsafe or ineffective due to adverse events. Additionally, manufacturers should be prepared to respond quickly and effectively whenever an adverse event or complaint is reported.

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Understanding the regulations 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

Quality Smart Solutions February 7, 2023

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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.

Quality Smart Solutions December 8, 2022

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Understanding MDALL/MDEL & How It Transforms Your Business (MDL, MDALL, MDEL Listing)

Navigating the medical device regulations set by Health Canada can be a complicated task, but knowing the specific classification

Quality Smart Solutions November 16, 2022

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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

Quality Smart Solutions November 1, 2022

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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

Femi Morakinyo April 29, 2022

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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

Jessica Koves March 11, 2022

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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

Dhreeti Kapoor March 8, 2022

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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

Jessica Koves October 28, 2021

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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

Kalpna Mistry October 11, 2021

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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

Andrew Parshad June 15, 2021

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Health Canada expedites access to COVID-19 diagnostic laboratory test kits and other medical devices

Recently in Canada, the Minister of Health has signed an Interim Order to allow expedited access to COVID-19-related medical devices

Quality Smart Solutions April 15, 2020