mdi ConsultantsHealth Canada Adjusts Medical Device Single Audit Program (MDSAP) Transition
On Friday, April 13th, Health Canada released an update regarding their transition to the Medical Device Single Audit Program, also known as MDSAP. If you’re not familiar with or have not heard of the MDSAP as a new initiative yet, it is a new program that allows a company to conduct a single regulatory audit of their quality management system to satisfy the requirements of multiple international jurisdictions. Currently, the 5 countries that are participating in MDSAP are Australia, Brazil, Canada, Japan, and the United States. Canada is the only country that has made MDSAP mandatory for class 2-4 devices while it is voluntary in all other participating countries. Recently, Health Canada has made adjustments to their requirements of the MDSAP program that will make it easier for manufacturers to transition to MDSAP by January 1st, 2019.
Health Canada will not take any enforcement actions against manufacturers that have undergone a full MDSAP audit in 2018 but haven’t received their certificate by December 31, 2018. Manufacturers have faced challenges scheduling MDSAP audits in 2018 because there are not enough MDSAP certified auditors and too many companies in need of the certification. Any manufacturers who are undergoing a full MDSAP audit in 2018 are still expected to submit a valid certificate with a form F202 to Canada’s Medical Devices Bureau (MDB) by December 31st, 2018.
Any manufacturer who underwent an initial recertification audit to ISO 13485 under CMDCAS (on or after January 1, 2016) will now be allowed to transition into MDSAP during the surveillance audit process. Manufacturers who transition to the program during a surveillance audit will not receive a MDSAP certificate in 2018 but they will retain their ability to sell their medical device(s) in Canada until they receive a MDSAP certificate. **Manufacturers will only gain the international accessibility of MDSAP once they obtain a MDSAP certificate after a full certification audit. Any manufacturers interested in transitioning to MDSAP via a surveillance audit must prove to Health Canada that:
- They have undergone an initial or re-certification audit to ISO 13485 under CMDCAS on or after January 1st, 2016
- They hold a valid ISO 13485 certificate issued under CMDCAS that has a validity period to at least December 31st, 2018
- As of January 1st, 2019, they continue to hold a valid ISO 13485 certificate (non-CMDCAS) issued by an MDSAP Auditing Organization, and
- They have undergone an MDSAP surveillance audit or have made arrangements to undergo an MDSAP audit.
In addition to these criteria, manufacturers must also provide the following documents to the MBD using form F202:
- A valid ISO 13485 certificate under CMDCAS issued after January 1st, 2016 and valid to at least December 31st, 2018
- A valid ISO 13485 certificate (non-CMDCAS) issued after January 1st, 2016 by a MDSAP Auditing Organization, and
- An MDSAP Surveillance Audit Confirmation Notification for a MDSAP surveillance audit having taken place in 2018 (This Notification should be prepared in accordance with MDSAP AU G0026.1 (Surveillance Audit Confirmation Notification Process) or evidence that they have made arrangements to undergo an MDSAP audit (e.g. signed certification agreement)
This adjustment is a temporary attempt to ease the transition of companies into the MDSAP program. if you market your device(s) to the 5 MDSAP countries, and especially Canada, and your devices are Class II or above, you need to start preparing to transition to MDSAP as soon as possible to ensure your company’s international compliance.
Remember if you are manufacturing Class I devices, the MDSAP would not apply to you at this time.
mdi’s staff has been trained in the MDSAP program and the 13485:2016 requirements. Please understand the process of upgrading your present quality system to the MDSAP program not an easy one to do. It can take several visits over a period of several months, and that is dependent on how compliant you are to the present FDA QSR and ISO 13485.
? To upgrade your present quality system or if you have any questions regarding MDSAP on how these changes may affect your company and how mdi can provide assistance or For any questions, comments or your regulatory requirement please email to info@mdiconsultants.com or use our contact form.