Health Canada Regulatory Approval Process for Medical Devices. The chart shown illustrates the Health Canada approval process and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page. Step 1. Determine the classification of your medical device according to Schedule 1 of the Canadian Medical Devices Regulations (CMDR). Devices fall into Class I, Class II, Class III or Class IV. Step 2. For all devices except Class I, Implement an ISO 1.
Difference Between Cmdcas And Iso 13485 Checklist
CMDR. Standard ISO 1. European market, does not meet Canadian requirements.
Updates to the existing procedures or new procedures must be implemented. Step 3. For all devices except Class I, have ISO 1.
ANVISA, TGA, and the U.S. FDA have also observed several assessments of CMDCAS Registrars as well as observed witnessed audits that have been. ISO/IEC 13485: 2003 represents the management system requirements for companies that want to maintain compliance with medical device regulations. 13485 could be. Our aim is to open the door for our customers to new markets and to further international certifications with established certifiers – in a faster, more effective. The main difference between the Acuhealth Pro 900 and the TENS Pro 900 is the system of return current (earthing facility) which enables the physician to use the TENS.
Registrar accredited by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS). Several large European Notified Bodies also act as Canadian Registrars.
The latest Regulatory Affairs / Reg affairs jobs - BETA Jobs: Regulatory Affairs / Reg affairs Quick Job Search. The Canadian medical device approval process explained. The chart shown illustrates the Health Canada approval process and is available for download in PDF format.
Your new ISO 1. 34. Step 4. For Class I devices apply for a Medical Device Establishment License (MDEL). For Class II, III, and IV devices, apply for a Canadian Medical Device License (MDL) application for your device.
Compared to a US 5. MDL applications are simpler for Class II devices and about the same for Class III devices. Class IV MDL applications are comparable to a US PMA application. Note that an MDL application is for the device itself whereas an MDEL is a permit for the distributor/importer, or a manufacturer of Class I devices. Step 5. For Class I devices, submit MDEL application, prepare mandatory procedures and pay Health Canada fees. For Class II devices, submit MDL application, IFU, Declaration of Conformity and ISO 1. Pay Health Canada fees.
For Class III and IV devices, submit MDL application plus Declaration of Conformity, ISO 1. IFU and Premarket Review Document following the STED format, which may include clinical data. Clinical data collected outside Canada is generally accepted. Pay Health Canada fees. Step 6. For Class IV devices, Health Canada will review your MDL application and Premarket Review Document. Step 7. Approved applications will be posted on the Health Canada website.
Step 8. You are now allowed to sell your medical device in Canada. Licenses do not expire but you must pay annual fees to Health Canada. Failure to pay fees will result in your approval license being revoked.© 2. Emergo Group. Chart updated: 3.