Examples of a specific type of nano-scale material could include nano titanium dioxide, nano silver, quantum dots, nano polymers, nano glasses, nano ceramics, carbon nanotubes and nano-fibres. For a device intended to be used with another Class II, III, or IV device, a list of all medical devices that this device is intended to be used or function with including their licence number , is required.
This is intended to be for system components from the same manufacturer. An important requirement in demonstrating compliance with the applicable requirements of sections 10 to 20 of all medical devices intended to be used together is compliance with section 18 of the MDR. Failure to submit compatibility information for interdependent medical devices may lead to delays in the pre-market review of device licence applications while the Medical Devices Bureau requests the necessary information and manufacturers assemble and submit it for review.
Manufacturers are therefore reminded that the submission of evidence of compatibility for inter-dependent medical devices is a requirement under the MDR. For Class II licence applications, the manufacturer is to list the recognized standards complied with, or attest that they possess objective evidence that the device either meets an equivalent or better standard or has been tested and alternate evidence of compliance with the applicable requirements of sections 10 to 20 exists.
If the manufacturer does not comply with any of these three options, a licence will not be issued. Indicate which review documents listed on the table are included as attachments to the application. For details regarding the safety and effectiveness information required of high-level disinfectants and sterilants, consult the guidance document: For details regarding the safety and effectiveness information required of contact lens disinfectants, consult the guidance document: Instructions are provided on the form itself.
The instructions given for each item must be carefully followed to avoid delays in application processing.
The instructions given for each item must be carefully followed to avoid delays in the processing of your application. Indicate which review documents listed on the table are included as attachments to your application. This section of the application form must be completed in detail.
If additional space is required, photocopy the page and attach it to the application form. Cadogan D, Howick C. Kroschwitz J, Howe-Grant M, eds. Kirk-Othmer encyclopedia of chemical technology.
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New York: Canadian Environmental Protection Act , Available from: Canada Gazette. Handbook of physical properties of organic chemicals. Boca Raton, FL: Lewis Publishers. Hazardous Substances Data Bank. July 18, Groundwater chemicals desk reference. Chelsea, MI: Lewis Publishers, Inc.
Registry of Toxic Effects of Chemical Substances. February Return to footnote 1 referrer.
You will not receive a reply. Skip to main content Skip to "About government" Skip to section menu. PDF Version - K. Chemical Identity of Di 2-Ethylhexyl Phthalate. Under the MDR , a new device licence is a pre-market requirement for: Licence Application Type ; a device previously authorized for sale for investigational testing, or under the special access provisions of the MDR, that is now to be offered for general sale.
Guidance Documents – Medical devices
Item 1: Name of the Device as it appears on the label. Manufacturer Information as it appears on the label. Item 3: Regulatory Correspondent Information. Item 4: Invoicing Information. Item 5: Quality Management System Certificate. Class II Licence Applications.
Near Patient Attestation. The manufacturer of the device must sign and date the application. Attestation Section.
Guidance Document - How to Complete the Application for a New Medical Device Licence
Item 7: Purpose or Intended Use of Device. Information provided for Item 7 is crucial to establishing the appropriate device class and should include the following: This system has been designed to help health care workers, who are contemplating the purchase of a Class II, III or IV medical device, to verify that the manufacturer has an active medical device licence. If you are in consultation with Health Canada and they are aware of the products, Health Canada may provide an option that allows you to bring products into Canada under certain conditions. As a Canadian dentist you have an ethical responsibility to use products that are legally permitted to be sold in Canada.
How do I know what medical devices require Health Canada approval? Do you have a contact person in Health Canada who can help me with these regulations? What section in Health Canada should I contact to find out what I must do to ensure the medical devices I am selling are safe and can be to sold in Canada? How long does it take for Health Canada to review applications? Registration Process White Papers. So you have one or more cleared medical devices in the US and now you want to license them in Canada.
While the Canadian QMS Compliance Webinars. Skip to main content. Expertise We help solve regulatory and compliance problems in the healthcare industry. Expertise Overview. We have deep expertise with a range of product types, including combination and borderline products. Comprehensive service offerings at every point in the product life cycle.
Medical Devices Bureau Performance Report - MEDEC
Services Overview. Services by Market. Our resource library is tailored to device professionals. View all resources. Featured Resource. Let us help you expand your reach.