If your medical device has successfully obtained a sanitary registration from COFEPRIS, you have cleared a major regulatory hurdle in Mexico. However, this authorization marks the beginning of a broader compliance lifecycle. In this article, we outline the key post-registration obligations and operational considerations that manufacturers, distributors, and registration holders must address to maintain regulatory compliance and ensure uninterrupted market access.
Import Permits: Tariff Code Requirements
Even when a medical device has a sanitary registration in Mexico, an Import Permit from COFEPRIS may still be required. This applies mainly to certain categories such as implants or high-risk devices, which are imported in large quantities for commercial distribution. The permit must be requested through the VUCEM platform by the registration holder or an authorized distributor and is generally valid for 180 days or for the approved number of units, whichever occurs first.
A common misconception is that sanitary registration alone eliminates the need for import permits. To avoid delays or compliance issues, it is strongly recommended to confirm the correct tariff code with a customs broker or regulatory consultant before initiating the import process. This step ensures that your products meet all applicable requirements and prevents potential fines or shipment holds.
Advertising: Notices and Permits
Medical device advertising in Mexico is regulated under the General Health Law and its associated regulations. COFEPRIS distinguishes between two types of advertising:
- Advertising Notice: Required for promotional materials directed exclusively at healthcare professionals. This notice must be submitted at least 15 days prior to dissemination.
- Advertising Permit: Mandatory for campaigns targeting the general public. This permit must be approved by COFEPRIS before launch.
Both procedures require that the final version of the advertisement includes the corresponding submission or authorization number. Non-compliance may lead to sanctions or suspension of marketing activities.
Labeling and Contra-Labeling: NOM-137-SSA1 Compliance
Medical devices distributed in Mexico must comply with NOM-137-SSA1, which outlines the minimum labeling requirements for packaging and product identification. While foreign manufacturers may retain their original labels, they must ensure all mandatory information is present. When the original label lacks specific details required by Mexican regulation (such as the product’s generic name, sanitary registration number, country of origin, or storage conditions) a back-label, over-label, or secondary label must be affixed to the packaging before commercialization.
This secondary label must be printed on adhesive material and include complementary information that aligns with the product’s instructions for use, technical documentation, and COFEPRIS registration. The responsibility for applying this label lies with the sanitary registration holder and/or authorized distributor, and it must be completed after importation but prior to distribution.
If the holder and the authorized distributor are separate entities, full responsibility falls on the distributor, as they are the party managing the product in storage, assuming operational responsibility. This flexible approach allows manufacturers to reduce operational costs while maintaining regulatory compliance in the Mexican market.
Storage and Warehousing: FEUM-Compliant Establishments
To register and distribute medical devices in Mexico, both the sanitary registration holder and the distributors listed in the registration must have access to a compliant warehouse. While there are no specific requirements regarding the size of the facility, the following conditions must be met:
- Warehouse Notice must be submitted to COFEPRIS, declaring the activities to be carried out.
- A Sanitary Responsible (Quality Manager) must be appointed. This person must be a qualified health professional with relevant experience and must be declared in the Warehouse Notice.
Warehouses must comply with the following Mexican standards:
- NOM-241-SSA1 – Good manufacturing practices for medical device establishments.
- FEUM Supplement for Medical Devices
- Supplement for establishments dedicated to the sale and supply of medicines and other health supplies.
- NOM-240-SSA1- Installation and operation of technovigilance.
- NOM-137-SSA1 – Labeling of medical devices.
The warehouse must implement a QMS that includes:
- Good Documentation Practices (GDP)
- Good Storage and Distribution Practices (GSP)
- Risk-based management principles
The QMS may be based on international standards such as ISO 9001, ISO 13485, and ISO 31000.
Technovigilance: A Shared Responsibility
Technovigilance, regulated under NOM-240-SSA1, is Mexico’s medical device surveillance system designed to ensure devices function correctly and to manage incident reporting. An adverse incident refers to any malfunction that could cause death or significant health deterioration. Reporting is mandatory when the event is linked to device malfunction, inaccurate labeling, unexpected risks, or diagnostic errors. Notifications must be submitted to the National Center of Pharmacovigilance (CNFV), and timelines vary: within 2 working days for public health threats, 10 days for incidents involving death or serious harm, and 30 days for other adverse events.
The sanitary registration holder is primarily responsible for implementing a technovigilance program and coordinating reports, although distributors, healthcare professionals and patients are encouraged to participate.
Reports can be filed online through COFEPRIS. Even if no incidents occur, a technovigilance report must be submitted every five years to maintain registration validity. This proactive approach ensures compliance and supports patient safety throughout the device lifecycle. It is important to start preparing these reports at least one year before the registration expires.
Conclusion: Sustaining Compliance in Mexico’s Regulatory Landscape
Obtaining a sanitary registration from COFEPRIS is a significant achievement, but it is only the beginning of your regulatory journey in Mexico. From import permits and advertising controls to storage standards and technovigilance, each post-registration obligation plays a vital role in maintaining market access and protecting patient safety.
Understanding and fulfilling these requirements ensures your medical device remains compliant throughout its lifecycle. Start your compliance process today—contact us for expert guidance, or explore our regulatory guidelines to stay ahead in the Mexican market.
