<h1 class="entry-title">Category: Canada</h1>

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”.

Health Canada intends to adopt GHTF Summary Technical Documentation (STED) format for class III and IV device applications

August 2009 The Therapeutic Products Directorate (TPD), Health Canada has announced that it intends to adopt the Global Harmonization Task Force’s STED guidance document published February 21, 2008 to encourage and support the global convergence of documentation requirements for medical devices.  Adoption of the STED as a basis for demonstrating conformity to the Essential Principles […]