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Health Canada Medical Device

Image result for Compliance to Health Canada Medical Device RegulationCompliance to Health Canada Medical Device Regulation

Due to application of national healthcare system and ever increasing population, Canada is considered as one of the lucrative market for medical device manufacturers. In order to market your medical device in Canada, you need to first comply with the Canadian Medical Devices Regulations (CMDR) and obtain the required level of approval from Health Canada.

Health Canada Medical Device License (MDL)

In Canada, you are required to obtain a Medical Device License (MDL) for your Class II, III or IV device. Quality workforce can assist you from start to end of this whole process including Quality management system development and implementation as per ISO 13485 requirement (along with additional QMS requirements outlined in the CMDR).
In order to receive your Medical Device license, your Canadian Medical Device Regulation based QMS is required to be audited by a Health Canada accredited ISO Registrar. Your Registrar must be in compliance with the Canadian Medical

Devices Conformity Assessment System (CMDCAS).

Along with development and implementation of ISO 13485 based Quality management system, Quality workforce consulting service also includes assistance in submitting your MDL application in full compliance with the Canadian Medical Devices Regulations (CMDR) to Health Canada along with appropriate documentation required for your device class.

Image result for health canadaHealth Canada Establishment License (MDEL)

A Medical Device Establishment License is   separate from a Medical Device License and is issued for the activities of importing and selling medical devices for human use in Canada. An MDEL is issued by the Inspectorate based on an establishment certifying that they meet certain requirements and are then inspected for compliance.
You are required to obtain a Medical Device Establishment License (MDEL) if you intend to market your Class I device, or if you intend to distribute / import medical devices into Canada. Quality workforce can assist you in receiving this license from start to end of the process Quality workforce can submit you MDEL application along with appropriate documentation.

Why choose Quality Workforce:

Quality Workforce services includes following:

  • Develop / modify your Quality management system in order to comply with ISO 13485 standard and applicable requirements of Canadian medical Device Regulation (CMDR)
  • Submission of completed MDL or MDEL application along with supporting paperwork

 



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