Up until March 1st 2016, the only ISO13485 recognized by Health Canada and accepted as part of a Medical Device application was a Canadian Medical Devices Conformity Assessment System (CMDCAS) ISO13485:2003 certificate from an approved registrar.
Recently both the ISO standard and the CMDCAS recognition have been updated. The following information is an important update that will impact all businesses holding or planning to hold either ISO13485 for the Canadian market or holders of private label medical device licences linked to a license with an ISO13485 certificate.
The new recognized ISO 13485
The International Organization for Standardization (ISO) recently published a revised version of ISO 13485 titled “ISO 13485 – Medical Devices – Quality management systems – Requirements for regulatory purposes.” This revised version (ISO 13485:2016) will supersede the version previously recognized by Health Canada ISO 13485:2003.
ISO 13485 Transition Period
Health Canada will recognize the ISO13485:2003 up and until March 1st 2019, after which date all businesses must comply with ISO13485:2016.
Health Canada has also announced their intention to transition the CMDCAS certificates to a new auditing system, Medical Device Single Audit Program (MDSAP).
CMDCAS to MDSAP Transition Period
Until December 1st, 2018, Health Canada will accept both MDSAP and CMDCAS certificates. Following this transition period, Health Canada will no longer accept CMDCAS certificates. In order to keep current medical device licences active, all medical device manufacturers must submit to Health Canada by January 1st, 2019 their new ISO certificate with the new MDSAP designation.
What does this mean to you
If you currently sell or are planning to sell medical devices with a Class 2 or higher Canadian designation in the Canadian market, this affects you.
These two concurrent changes will have a potential impact on your quality processes, and the frequency and depth of audit you will undergo during future registrar audits.
How can we help?
NHP Consulting is more than just your registration partner. We assist companies to plan product pipelines, review transitions, map processes, plan major changes, evaluate risk, audit their facilities and mitigate compliance, quality, and safety issues.
Based on your plan-to-market and how your product is registered today, we can help you plan the ISO/MDSAP transitions smoothly, so you are ready for the deadline transition on time.
If you are a manufacturer, importer or distributor of medical devices we recommend analyzing your product offerings to ensure that you (your manufactured products) and/or your suppliers are aware of and planning the transition in line with Health Canada timelines
NHP Consulting can assist and guide you in this process by providing:
- Product review
- Process review
- Communication support to suppliers
- Facility/product audits
- Project planning
Our other services:
We are happy to offer other services related to medical devices such as:
- Pipeline project planning
- Facility audits
- Registration support
- Process mapping and improvement
- Project management
- Product classification support
- Market research
- Clinical trial support
- Label review
- Quality Management System development, implementation and support
- Virtual QA/RA department
- Post market support
- Let us manage on your behalf those difficult recalls and complaints.
- Product and process changes
For more information on our various services, feel free to contact us at 647-376-3252.