Luisa Gutiérrez
Director General

Product Registration in Mexico Gets Streamlined

Wed, 09/07/2016 - 12:49

When international companies decide to enter the Mexican market, they are extremely enthusiastic to take advantage of the many opportunities it offers. However, they either perceive the regulatory framework as a complicated barrier or are unaware that they need to plan a strategy to effectively register their products in Mexico. Despite offering high-quality services, international consulting firms usually lack local knowledge and this is where Medisi becomes relevant since it supports international companies in developing a strategic approach to regulatory affairs to achieve commercial goals. For instance, as new product registrations can take up to a year and a half, companies can spend 12 months putting a dossier together. This is not encouraging for medical devices companies willing to launch new versions of their equipment every year, which is why product registrations in Mexico should be planned strategically.

Companies interested in entering the Mexican market should be correctly advised to avoid a path full of obstacles and disappointment. “Regulations are usually seen as mere requirements to be met,” says Luisa Gutiérrez, Director General of Medisi. “When in reality, regulatory affairs strategies have a tremendous impact on the commercial success of a product.” Some companies need to register 10 products in a row while others 35. A common mistake is undergoing an individual submission process for each of the products when they could strategically group them according to their manufacturing and core features. As Gutiérrez says, medical devices companies need to be aware that product registrations in Mexico can take from 17 to 25 months, and Medisi can do it in 7 1/2-13 1/2 months due to their efficient submissions and follow-up. “We have a project management tool that is useful for determining milestones, timescales and the workload,” she adds. “If something gets delayed by COFEPRIS, we will notify our client and develop a plan to decide the most appropriate way to optimize time to market.”

Regulatory timelines in Mexico have become quite competitive around the world due to vast improvements made by COFEPRIS in the last three years. Nonetheless, there are still some challenges such as regulatory offices providing bilingual services to companies outside Mexico. Also, as many distributors and companies ignore the requirements to submit a dossier, regulatory agents spend more time than they should reviewing incorrect submissions. “Historically, COFEPRIS has had a huge backlog on reviewing submissions, which is partly because they never deny an authorization without asking for further information first,” Gutiérrez says. She also considers that COFEPRIS needs to optimize a regulation for medical devices. “COFEPRIS needs to better understand medical devices as it is a universe of diverse products. Wound care materials are completely different from medical equipment such as a laser treatment for cancer. In my opinion, we are moving toward a more accurate classification for medical devices.”

The classification according to risk has I, Ia, II, and III categories requiring different legal documents. Classes I, II and III take between three to seven months to obtain a registration with COFEPRIS plus the time it takes to prepare the dossier, while it takes between 2.5 and six months to get a registration through a third party authorized unit. Medisi help its clients get a dossier in four months, so the whole registration process is completed within a year.

For Gutiérrez, the opportunity for medical devices companies is huge. Mexico’s total population is about 128 million inhabitants. Launching a product targeting 2 million people in Mexico equals covering one-third the population of Israel. However, registration processes can be convoluted for international companies when they do not have the knowledge in negotiating the arena. “They usually believe that contacting a local partner or a distributor will solve all their problems,” Gutiérrez says. “On the other hand, many other companies have realized that it is worth having their own registrations in Mexico and they are striving to expand their portfolio in the country.”

Medisi employs 25 people including quality assurance, regulatory affairs and business development experts. It is now focusing on providing training to companies so they understand Mexico’s regulatory framework and realize there is always a strategy to easily obtain product registrations. “We are also aiming to expand to places with a similar environment to Mexico. We are interested in building strategic alliances in Latin America – a region with great potential yet to be unlocked.”