Manufacturers seeking to commercialize their medical devices in Canada must obtain a Medical Device Licence (MDL) from Health Canada (HC). Meanwhile, in Mexico, medical devices require a Sanitary Registration issued by COFEPRIS before they can be marketed. One of the most efficient pathways for obtaining this registration in Mexico is the Equivalency Agreement route, which leverages prior approvals from recognized regulatory bodies, including HC, U.S. FDA and MHLW/PMDA. This article explores how MDLs can facilitate faster market entry in Mexico through this streamlined process.
Understanding how devices are licensed in Canada
Health Canada categorizes medical devices into four classes based on risk:
- Class I – Low risk: no MDL required; Medical Device Establishment License (MDEL) needed for manufacturers, importers, and distributors.
- Class II – Moderate risk: requires an MDL
- Class III – High risk: requires an MDL with additional clinical data
- Class IV – Highest risk: requires an MDL with stringent clinical and technical reviews.
Summarized process to Obtain an MDL
- Determine device classification (Class I-IV).
- Prepare technical documentation and QMS under ISO 13485/MDSAP (Class II-IV).
- Submit application to HC and perform payment of fees.
- Undergo review
- HC Issue MDL
How to use MDL to leverage COFEPRIS Sanitary Registration in Mexico
In Mexico there are two Registration Pathways:
- Standard Route (Ordinary Process): Requires full technical and legal documentation.
- Equivalency Agreement (Fast-Track Process): Rely on prior approvals from HC MDL.
The main benefits of the Equivalency Route are the reduced documentation required, as only key approval documents are required. Faster approval, usually quicker than standard route.
Another point to consider is the possibility of lowering costs due to the reduced translations needed.
Key Requirements for Equivalency Route Submissions
- Valid MDL for Class (II-IV)
- GMP Certificate: ISO 13485 or MDSAP certificate.
- ISO 17021 certificate (accreditation scope)
Special considerations
Devices classified as Class I in Canada are not eligible for Equivalency Route. Sometimes the classification of risk is coincident in Mexico and Canada (Class II or Class III) but a new assessment must be done considering local rules.
An important topic to consider is that all models intended to be registered in Mexico must be listed in the corresponding MDL.
Whilst the Equivalency Route for HC does not require a Certificate of Free Sale, all the other legal documents must be apostilled.
How an MDL Supports Equivalency Registration in Mexico
- Streamlined Submission: Since HC’s licensing process aligns with international standards, manufacturers can reuse much of their technical documentation for COFEPRIS submission.
- Faster Market Entry: HC’s MDL approval times are consistently lower that COFEPRIS so MDL can be leveraged for Mexico’s equivalency review.
Conclusions
For medical device manufacturers, accounting with an MDL not only grants access to the Canadian market but also simplifies entry into Mexico via the COFEPRIS Equivalency Route. By leveraging prior approvals, companies can reduce regulatory burdens, lower costs, and accelerate time-to-market.
However, navigating both Health Canada and COFEPRIS requirements demands careful planning. Partnering with regulatory experts can ensure compliance and optimize the approval process for both jurisdictions. Would you like additional insights into how to get successful equivalency registrations? Please contact us at Veraque.
