For medical and in vitro diagnostic (IVD) devices, a COFEPRIS approval is required prior to market entry in Mexico. The Federal Commission for Protection against Sanitary Risks was established in 2001 and is mandated to protect the population against sanitary risks by ensuring the quality and safety of health-related products in accordance with Article 17 Bis of the General Law of Health and Article 4 of the Constitution.

In addition to registering and licensing medical and IVD products, COFEPRIS also regulates the advertising of these same products in order to ensure that advertising campaigns do not present any public health risks. Whether it is the manufacturing, importing, or exporting of pharmaceuticals, medical devices, or food, COFEPRIS regulates everything that enters and exits the country as part of its mission to protect Mexico’s population from sanitary risks.

COFEPRIS Procedures

The Mexican regulatory authority is currently undergoing major restructuring, which has resulted in significant backlogs of applications for registrations and import permits. The reforms aim to improve transparency, reduce bureaucracy, and speed up processing times. However, the reforms will have a negative impact on the budget, which may force tramites de COFEPRIS to cut funding for key initiatives such as pharmacovigilance and research and development programs.

COFEPRIS’s approval process varies by device classification and the type of clinical data required. The process can be lengthy and complex. COFEPRIS requires detailed technical and scientific information about the device, including performance and quality, as well as clinical data that proves its efficacy, safety, and benefits. This can be achieved by conducting clinical trials or by submitting existing clinical data from post-market surveillance studies and published literature.

Orphan drugs are a recent addition to the General Health Law and Mexican Pharmacopeia. The rules governing their approval are being tested, and the recognition of data package exclusivity is a particular issue.

A new procedure has been implemented to accelerate the process of obtaining a marketing authorisation for a medicinal product by allowing manufacturers with foreign marketing authorisations to undergo a pre-examination of the formal and substantive requirements by an authorised health institution. This is hoped to reduce approval timeframes by up to 60 working days.

Regulatory compliance is critical to maintaining a successful business in Mexico. This includes ensuring that all operations and processes at an establishment comply with applicable health regulations, especially those related to GMP inspections. A good way to manage this requirement is to appoint a Mexico Registration Holder, who can be responsible for managing the entire process and interacting with COFEPRIS on your behalf. They can also manage the submission of a technical file to the NMC and provide you with a technical opinion within 20 working days. This is an important step to avoid any delays in completing the registration process. The technical opinion can be used to support your final submission to COFEPRIS.