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Health Canada CMDR Updates 2021 – ComplianceAcuity

WebHealth 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 …

Actived: 5 days ago

URL: https://www.complianceacuity.com/health-canada-cmdr-updates-2021/

Health Canada Medical Device Importer Requirements for DTC Sales

WebWhen dealing with Health Canada’s medical device regulatory requirements (i.e., SOR/98-282 as amended from time to time, hereinafter the “CMDR”), there are four …

Category: Medical 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

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: 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 …

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 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 System License

WebHealth 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

EU eIFU Regulation: Broader Than Many Think – ComplianceAcuity

WebSpecifically, the Commission’s Directorate General for Health and Food Safety told me that if ever an eIFU is provided for medical devices in the Union, whether …

Category: Food, 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 document …

Category: Health Go Health

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

WebFor example, when I do a Part 806 report for a Class I or II recall, there are certain section 806.10(c) elements [e.g., subsections 7, 8, 9, 12, etc.] that are addressed …

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 gaining ground, but still backlogged in device …

WebOctober 2010. In its September 7 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), …

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

Health Canada decides to delay full STED implementation until …

WebOn June 17th, Health Canada announced that the full STED implementation will be delayed for an extra year, until July 1, 2011, to allow for additional work and …

Category: Health Go Health

Internal/Mock Audits – ComplianceAcuity

WebFDA Field Management Directives (FMD) & CP 7382.845. As part of the mock audit, ComplianceAcuity provides sincere feedback and coaching to identify your strengths and …

Category: Health Go Health

Health Canada requests electronic filing of some device license

WebJanuary 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 …

Category: Medical Go Health

Health Canada backlogged in processing of device license …

WebFebruary 2010. In its February 25 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), …

Category: Medical Go Health

U.S. 510(k), PMA, IDE, NDA / ANDA/ – ComplianceAcuity

WebWe’ve also got specialists to handle various drug product approvals from FDA’s CDER. Specifically, our hands on experience includes: 510 (k) [traditional, abbreviated, special, …

Category: Health Go Health

EU MDR Transitional Extension Regulation (EU) 2023/607 and …

WebMarch 27, 2023. EU MDR Transitional Extension Regulation (EU) 2023/607 and Previously-Expired MDD/AIMDD Certificates . Even if an MDD/AIMDD certificate from 25 May 2017 …

Category: Health Go Health

Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

WebDevices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Tobacco Products (CTP), and the Center for …

Category: Nutrition, Food Go Health