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Health Canada: Licence Amendment vs New Licence Application

WEBSome changes can be made via relatively abbreviated amendments using an abbreviated mechanism/format offered by Health Canada, while other amendments need a full …

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URL: https://www.complianceacuity.com/health-canada-licence-amendment-vs-new-licence-application/

Health Canada CMDR Updates 2021 – ComplianceAcuity

WEBHere’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, …

Category: Medical Go Health

Health Canada Class IV Device Licence Amendment and Fee Forms

WEBFor a Health Canada Class IV medical device licence amendment, there are generally two types of forms needed: On the Application Form, we can bundle multiple …

Category: Medical Go Health

Health Canada Medical Device Importer Requirements for DTC Sales

WEBHealth Canada Medical Device Importer Requirements for DTC Sales. When dealing with Health Canada’s medical device regulatory requirements (i.e., SOR/98-282 …

Category: Medical Go Health

Canadian Device and Establishment Licenses – ComplianceAcuity

WEBYour firm will be empowered to take an efficient and cost-effective route to the lucrative Canadian market when you tap into ComplianceAcuity’s organic Canadian experience, …

Category: Health Go Health

Notifying Your European Notified Body About Non-Significant …

WEBJanuary 11, 2024 . Notifying Your European Notified Body About Non-Significant Changes . Europe’s Union MDR (Regulation 2017/745) includes legislative authority (e.g., in Annex …

Category: Health Go Health

Health Canada Medical Device System License

WEBIn general, components of a licensed medical device system can be sold separate from the system on the condition that the label of each component bears the …

Category: Medical Go Health

Health Canada intends to adopt GHTF Summary

WEBAugust 2009. The Therapeutic Products Directorate (TPD), Health Canada has announced that it intends to adopt the Global Harmonization Task Force’s STED guidance …

Category: Health Go Health

Canada – ComplianceAcuity

WEBJune 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 …

Category: Medical Go Health

Health Canada decides to delay full STED implementation until …

WEBJune 2010. As ComplianceAcuity previously reported in August 2009, Health Canada’s Medical Devices Bureau issued a notice proposing to fully implement the use …

Category: Medical Go Health

Recall Classification: EU MDR / IVDR – ComplianceAcuity

WEBFebruary 20, 2023. Recall Classification: EU MDR / IVDR . Neither the EU MDR nor IVDR contain a formal risk-classification scheme for recalls. So in general, other jurisdictions’ …

Category: Health Go Health

FDA Remote Regulatory Assessment – ComplianceAcuity

WEBFDA proposed a date for conducting the RRA. FDA explained that an RRA is a review of records and information provided by the inspected firm to gain information …

Category: Health Go Health

Health Canada authorizes e-labeling for certain medical devices …

WEBNovember 2010. On November 9, Health Canada’s Therapeutic Products Directorate (TPD) issued a permissive notice immediately authorizing device manufacturers of certain …

Category: Health Go Health

Health Canada – ComplianceAcuity

WEBApril, 6, 2023 Health Canada Medical Device System License Components Sold Separately In general, components of a licensed medical device system can be sold separate from …

Category: Medical Go Health

EU MDR PMCF: To Waive or Not to Waive – ComplianceAcuity

WEBThe option for PMCF waiver is clearly and repeatedly stated by the EU MDR, such as: Annex IX.2.1 eighth and ninth indents (available as an option for Annex IX …

Category: Health Go Health

FDA UDI for Class 1 510(k)-Exempt Devices – ComplianceAcuity

WEBIf Class I but not GMP-exempt, then September 24, 2022 is the FDA enforcement discretion compliance date for the 801.18, 21 CFR 801.20, 21 CFR 801.50, …

Category: Health Go Health

ISO 14971 Probability of Occurrence of Harm – ComplianceAcuity

WEBMoreover, the consideration of device lifetime as part of estimating probability of occurrence harm remains a modern best practice today in the latest versions (see ISO 14971:2019 …

Category: Health Go Health

Recall Classification: U.S. FDA – ComplianceAcuity

WEBFebruary 20, 2023. Recall Classification: U.S. FDA . For the U.S. FDA, a risk-based approach is required for categorizing a recall; for planning and implementing a recall …

Category: Health Go Health

FDA 21 CFR Part 7 vs. Part 806: What’s the Difference

WEBThe most succinct way I’ve seen FDA correlate 21 CFR Part 806 with 21 CFR Part 7 is by stating that Part 806 reports of corrections and removals are required …

Category: Health Go Health