EMERGO SUMMARY OF KEY POINTS:

• Health Canada will begin requiring Medical Device License (MDL) holders to participate in the Medical Device Single Audit Program (MDSAP) in early 2019.
• So far, only 215 of about 3,500 MDL holders required to sign up for MDSAP have done so.
• Roughly 10% of Health Canada MDL holders are Private Label Medical Manufacturers that do not have to meet ISO 13485 or MDSAP quality system requirements.

A fraction of manufacturers with active Canadian Medical Device Licenses (MDL) that must sign up for the Medical Device Single Audit Program (MDSAP) have done so, according to Health Canada.

Emergo consultants in Toronto and Vancouver have received data from Health Canada that roughly 215 MDL holders have either signed up for or been audited via MDSAP as of March 2017. The regulator states that as of April 13, 2017, however, 3,728 medical device manufacturers hold valid MDLs for Class II, III and/or IV devices sold in the country.

From CMDCAS to MDSAP

Obtaining an MDL in Canada requires compliance with the ISO 13485 quality management system standard, as well as with Canadian Medical Devices Regulations (CMDR); Health Canada quality system requirements are implemented via the Canadian Medical Device Conformity Assessment System (CMDCAS).

However, Health Canada plans to establish MDSAP as the single program for verification of MDL holders’ CMDR quality system compliance; conversion from CMDCAS to MDSAP began in late 2016, and is required to be complete by January 2019.

Thousands of manufacturers still need to sign up for MDSAP

Revisiting the Health Canada estimate of 3,728 MDL holders active in Canada, about 10% of these entities are Private Label Medical Manufacturers that do not require ISO 13485 certification but rather operate as original equipment manufacturers (OEM). In other words, these MDL holders will not have to meet MDSAP requirements in 2019.

Based on data from Health Canada that less than 10% (239 firms) of all manufacturers with MDLs in Canada are Private Label Medical Manufacturers, that would mean that about 3,200 manufacturers still require ISO 13485 certification—and ultimately must switch to MDSAP. Currently, only seven percent of those manufacturers have signed up for or been audited under MDSAP; the remaining 93% of MDL holders must do so by January 2019. Thus, a huge majority of MDL holders have MDSAP compliance work ahead of them in order to meet Health Canada’s implementation deadline.

Canadian market resources and support:

• Health Canada Medical Device License registration service
• Compliance support for CMDCAS, MDSAP and ISO 13485 quality system requirements
• Whitepaper: Health Canada MDL applications
• Video overview: Canadian medical device registration