A new medical device regulation in Mexico offers an accelerated approval timeline for certain devices, but time will tell how fast it really is.
Miguel Angel Torres Tello, Veraque Consulting
Mexico is known as a relatively complex market for medical devices in regulatory terms. Still considered the second-largest market in Latin America, Mexico offers three different routes to request a sanitary authorization. In this article, we would like to describe the equivalency route, the fastest regulatory pathway at the moment.
The standard timeframe to receive commercial approval for a medical device is around one year upon submission to COFEPRIS (Mexico’s medical device regulatory body, the Federal Committee for Protection from Sanitary Risks). No matter the classification of the device (except some limited cases), one year is what the industry has had to wait to have access to the country.
But the demand for COVID-19-related supplies and a public healthcare sector pushing to improve prices have bolstered the need for unprecedented measures. On November 18, 2020, the Ministry of Health in Mexico established new, expedited timelines for medical devices and pharmaceutical supplies. Now the authority is requiring five working days to respond to any new registration request under the so-called equivalency agreement. If it is not resolved in that period of time, the submission must be considered as granted.
The equivalency agreement route is not new. This regulatory alternative was published in 2010, providing faster access to the market for those medical devices approved by the FDA and Health Canada. Two years later, Mexican regulators extended the equivalency agreement to those devices approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan.
When the first equivalency agreement was announced in 2010, submissions were approved within two to three months. The rate increased over the years to end up at six to eight months, probably due to high demand and the bigger workload for COFEPRIS reviewers. Although the latest equivalency agreement provides a five-day legal timeframe to resolve a request, the real timelines may increase over time.
Key points to consider
In addition to better timelines, there are other perks of requesting a sanitary registration through the equivalency agreement pathway — specifically, less technical and legal documentation compared to other regulatory routes, and reduced translation costs.
However, the equivalency agreement route is not an immediate recognition of the approvals in the above-mentioned countries (U.S., Canada and Japan). Therefore, it is very important to carefully evaluate if the products are eligible for this route. These are some of the key points to consider:
- The equivalency route is not applicable for Class I medical devices approved by Health Canada or the MHLW in Japan.
- Even though Class I, II and III FDA-approved medical devices are eligible for the equivalency route, the Establishment Inspection Report (EIR) is a requirement. In our experience, this is not a document easily released to any type of medical device manufacturer. Nevertheless, COFEPRIS has expressed that ISO 13485 or MDSAP (Medical Device Single Audit Program) certification is acceptable in case the EIR is not presented.
Finally, a common question from our clients is if this route is strictly intended for companies located in U.S., Canada or Japan. The answer is no. No matter where your company is located, you are eligible for the equivalency agreement if you have approval in the U.S., Canada or Japan.
A minor caveat is that you may experience some hurdles legalizing certain documents. For instance, FDA documents must be apostilled and notarized in the U.S. Therefore, we strongly recommend that you receive feedback from experienced regulatory specialists to tackle these and other possible requirements.
Even though the latest Ministry of Health announcement improves the timelines in COFEPRIS, you should be cautious in your projections. We are not sure how COFEPRIS is going to deal with the immediate demand.
Miguel Angel Torres Tello has more than 10 years of experience in the medical device sector. He is co-founder of Veraque Consulting, a firm with the mission to provide access to the medical device market complying with local regulations.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.