Webinar: Medical Device Regulations in Mexico
In this webinar, Priya Bhutani introduces an overview of the regulatory process for medical devices in Mexico, featuring expert Rebeca Estrada. Estrada, with over 20 years of experience, discusses the classification of medical devices, which follows a system similar to the European Union's but without certain categories like Class 2A or 2B. Devices are classified into Class 1, 2, or 3 based on their risk and duration of body contact.
She explains the two main pathways for product registration: the traditional pathway, which requires extensive documentation and typically takes 8-10 months, and the abbreviated pathway, which is intended to be faster for products already approved in countries like the U.S. or EU but often takes longer in practice.
Estrada highlights the role of third parties in the approval process, noting they can help prepare and review submissions for the traditional pathway, potentially expediting approval. However, they are not involved in the abbreviated pathway. Local representation is also discussed; foreign manufacturers must have a legal representative in Mexico, ideally with a warehouse, to facilitate compliance.
The session encourages audience participation and feedback, and a Q&A is planned to address attendees' experiences and questions about the regulatory process.