April 24, 2023 “Declaration of Conformity” vs. “Certification of Conformity” There are different kinds of declarations and certifications germane to the medical devices sector. And there is a proper distinction to be made between “declaration” and “certification”. I give my further interpretations about that herein. Ultimately, the precise context of each given scenario […]
<h1 class="entry-title">Category: Canada</h1>
Health Canada Class IV Device Licence Amendment and Fee Forms
February 24, 2023 Health Canada Class IV Device Licence Amendment and Fee Forms For a Health Canada Class IV medical device licence amendment, there are generally two types of forms needed: Class IV Medical Device Licence Amendent Application Form Medical Device Application Fee Form On the Application Form, we can bundle multiple […]
ISO 13485 QMS Planning vs. Quality Plans
July 19, 2021 ISO 13485 QMS Planning vs. Quality Plans I think it’s important to remember that the general quality management system planning and set-up called for by ISO 13485 clause 5.4.2(a) is fundamentally distinct from clause 7.1’s product/project/object/output-oriented planning. If they were the same, then ISO TC/210 would not have separated and distinguished […]
Risks from an Inadequate Development Process for Software
July 19, 2021 Risks from an Inadequate Development Process for Software The most fundamental reason for medical device design and development controls (e.g., ISO 13485 clause 7.3; the U.S. FDA’s 21 CFR 820.30, etc.) is to control risks that come from an inadequate development process. That fact is unequivocally true and stands in stark contrast to […]
Health Canada CMDR Updates 2021
June 28, 2021 Health Canada CMDR Updates 2021 Here’s a quick recap of Health Canada’s changes to the Medical Devices Regulations (SOR/98-282) that started coming into force on 23 June 2021: Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to […]
Health Canada authorizes e-labeling for certain medical devices not sold to the general public
November 2010 On November 9, Health Canada’s Therapeutic Products Directorate (TPD) issued a permissive notice immediately authorizing device manufacturers of certain categories of devices to provide, in electronic format instead of paper format, the information ordinarily found in the directions for use pursuant to Section 21(1)(i) of the Canadian Medical Devices Regulations. The permissive notice […]
Health Canada gaining ground, but still backlogged in device license application processing
October 2010 In its September 7 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), ComplianceAcuity confirmed that the Bureau is still wrestling with a significant increase in the volume and complexity of device license applications during the last 12-18 months. As the Bureau grapples with the influx, […]
Health Canada decides to delay full STED implementation until July 1, 2011 for non-in vitro diagnostic Class III and IV Medical Devices
June 2010 As ComplianceAcuity previously reported in August 2009, Health Canada’s Medical Devices Bureau issued a notice proposing to fully implement the use of the GHTF STED format for Class III and IV premarket Medical Device License Applications by July 1, 2010. On June 17th, Health Canada announced that the full STED implementation will be […]
Health Canada backlogged in processing of device license applications
February 2010 In its February 25 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), ComplianceAcuity confirmed that the Bureau has seen a significant increase in the volume and complexity of device license applications during the last 12-18 months. As the Bureau grapples with the influx, the processing […]
Health Canada requests electronic filing of some device license applications
January 2010 Effective January 1, 2010, all Class IV medical device license applications should be submitted in both a paper and electronic format and be prepared using the specifications outlined in the December 14, 2009 guidance document “Preparation of a Premarket Review Document in Electronic Format for a Class IV Medical Device License Application”.