MDSAP Transition Q&A with Health Canada (HC)
December 12, 2018 Conference Call Summary
Top 10 Highlights:
1. The deadline to transition from CMDCAS to MDSAP is January 1, 2019 for medical device license holders of Class II, III, and IV Medical Device Licenses. The MDSAP transition requirement is not applicable to Class I medical devices (these devices did not have a CMDCAS requirement) or Private Label devices (MDSAP requirements are placed on the original license holder not the private labeler).
2. MDSAP Certification and future renewal requirements are a separate process from annual medical device renewal requirements. Annual medical device renewal forms will continue to be e-mailed to license holders in August each year and must be returned by November 1 of that year, this is a separate process from MDSAP Certification/renewal.
3. Manufacturers should submit MDSAP Certification before January 1, 2019 using HC Form 202. Sections A, B, and D should be completed:
a) Section A: List the expired “CMDCAS/ISO 13485 Certificate”.
b) Section B: List the MDSAP Certificate number if available, otherwise list the new “Non-CMDCAS/ISO 13485 Certificate” number.
c) Section D: List ALL medical device license numbers the manufacturer has with HC which are affected by the change. Listing only the manufacturer’s ID number is not enough, list ALL device license numbers to ensure HC does not overlook any licenses. An appendix may be attached if the space provided on the F202 form is not sufficient.
4. Manufacturers that will not have MDSAP Certification before January 1, 2019 will be able to submit an “MDSAP Transition Package” in its place. The package should consist of:
a) Written confirmation from an AO with either a, 2019 Notice of Audit Confirmation, a 2018 audit report, or 2018 Closing Meeting Minutes (signed), and
b) “CMDCAS/ISO 13485 Certificate” to show presence of a compliant quality system during 2018, and
c)“Non-CMDCAS/ISO 13485 (2003 or 2016) Certificate” which covers January 1, 2019 through the scheduled audit date in 2019. Please note ISO 13485:2003 expires in February 2019 so if the audit date is beyond February 2019 a “Non-CMDCAS ISO 13485:2016 Certificate” will need to be provided on Form 202 before version 2003 expires to keep manufacturers in compliance.
5. Manufacturers that will not have MDSAP Certification or an acceptable “MDSAP Transition Package” before January 1, 2019, will not have their licenses automatically canceled. Manufacturers are given a 30-day grace period, after that HC will email/write manufacturers with an initial warning, after that HC will call the manufacturers. HC will only cancel licenses after all attempts are made to contact the manufacture and come up with a solution as per Section 40(3)(c) of the Medical Device Regulations.
6. HC will work with manufacturers to try and find solutions to meet the upcoming MDSAP requirements, please email or call Ian Sullivan with any questions so he and his team can assist manufactures to ensure licenses do not get canceled during the transition.
7. HC may be able to prevent a license from being canceled, but HC cannot reinstate a license after it has been canceled, so please do not let your existing license be canceled if you are considering MDSAP.
8. For manufacturers that have not yet submitted their “2018-2019 License Renewal Packages” for existing medical device licenses and may have received renewal warning letters with a December 7, 2018 deadline, HC has not been canceling these licenses yet. HC is contacting manufacturers to find out if MDSAP is the reason for the delay in renewal, and where applicable will work with manufacturers to try and find an MDSAP solution. However, these will be cancelled soon so please contact HC for licence renewal immediately, if required.
9. HC has spoken with Health Care Providers (HCP) and has determined that the number of medical products, parts, components, or accessories estimated to be discontinued due to MDSAP is not significantly higher than what they see annually due to commercial reasons. The estimated numbers are thought to be slightly higher but there are equivalent replacements available to HCP so that little to no impact should be seen by the HCP. HC is working with HCPs to make them aware of the replacements available to them. Wherever no equivalent replacements are available HC is dealing with these on an individual basis.
10. Special Access Program (SAP) will remain available to HCPs but manufacturers should not consider SAP as a bypass for the MDSAP requirement. The SAP is reserved for devices that do not have equivalent products on the market readily available and is not a good option for manufacturers to use to try and avoid MDSAP Transition.
Contact Ian Sullivan (Health Canada) at [email protected] or +1 613.948.7194