The fact that Canada will depend only on the MDSAP program to cover their Regulatory QMS requirements after the end of this year is causing great challenges and issues for medical device manufacturer. It has been proven to be complex or in many cases impossible to meet this deadline as the 14 recognized MDSAP auditing organization are extremely busy to meet the demand for audits due to this new program; in addition, it stimulates the shift of manufacturers to move to secure and bigger NBs in light of the future MDR NB designations, which adds to the resource crunch. The lack of resources becomes imminently visible in the price structure for the certification, where even for very small companies the initial certification costs will easily reach 50.000 Euro if no corrective actions will be needed following the stage 1 and stage 2 audits. The significant increase in cost alone has resulted in manufacturers with lower turn over to drop Canada as a go-to market.
Two distinct alternative routes have been put in place for those cases where manufacturers are not able to fully meet the deadline of 31 December 2018.
In order to create some leniency for companies that have done their best and arranged their MDSAP audits before the deadline, but that might not be able submit a certificate in time, Canada just now announced that there will be some leeway in the deadline for submitting the required certificate and the possibility to allow a more gradual approach to reach full certification.
Some delay in MDSAP certification is going to be accepted by Health Canada, provided that the manufacturer can show an MDSAP audit has taken place in 2018. I.e. the need to submit a new or changed QMS certificate before 31 December 2018 will not fully be enforced by Health Canada if the company provides evidence that an MDSAP certification audit was conducted by a recognized Audit Organization (AO) in 2018.
The second alternative that could provide some slack is to use the current planning of your CMDCAS audit cycle. If recertification of your current CMDCAS certificate is done after Jan 1st, 2016, then your current surveillance audits may be used to plan MDSAP surveillance audits to transition smoothly into MDSAP, while in the meantime you are still allowed to sell your product in Canada, provided a valid ISO 13485 certificate is maintained by the same MDSAP auditing organization. prior to receiving your MDSAP certificate after 2018. This implies the organization to have moved to ISO 13485:2016.
However, by doing so, one should be aware that the benefits of MDSAP to market access and or replacement of inspection by authorities of other MDSAP jurisdictions (other than Canada) can only be used when full compliance for the applicable jurisdiction is reported and submitted by the AO to those authorities. And do not fall into the pitfall to only focus on meeting Canadian requirements during these audits as this will lead to failure in receiving a MDSAP certification at all, as the MDSAP scope by default is all of the regions where products are being marketed by the manufacturer. To arrange your plans to use the MDSAP surveillance scheme, it is required to submit a so-called F202 notice of change to HC before 31 December 2018 to demonstrate you have a valid CMDCAS certificate which was renewed after 1 Jan 2016 (and valid until 31 December 2018), a valid ISO 13485 certificate from one of the Auditing Organizations that can be maintained beyond the end of this year and a confirmation from the AO that the first MDSAP surveillance audit was planned or conducted before the end of this year.
This latest notice from Health Canada does address the problem manufacturers have experienced to timely arrange a full MDSAP audit from the AO’s, however it does not change the fact that you need to prepare your QMS and organization for an MDSAP audit and have to receive or at least schedule your first MDSAP audit before the year is over.
If you want to know more, please check our Open Training MDSAP in different locations:
Qserve can support upgrading your QMS to MDSAP, as well as preparation for towards a successful certification / upgrade audit. Read more on our QMS support here.