COFEPRIS Mexico Medical Device Regulations
COFEPRIS must approve your regulatory application before you can sell your medical device in Mexico.
Key medical device and IVD regulations in Mexico
The Comisión Federal para la Protección contra Riesgos Sanitarios, known as COFEPRIS, is the division within the Mexican Secretariat of Health that regulates medical devices in Mexico. COFEPRIS medical device regulations cover advertising, manufacturing, and importation of health-related products and industries, including drugs, food, medical devices, organ transplants, and even environmental protections. Before you can import and sell your medical device or IVD in Mexico, COFEPRIS must review and approve your regulatory application.
COFEPRIS enforces requirements in two primary health regulations:
- General Health Law (Ley General de Salud) outlines the regulatory framework for medical devices and pharmaceuticals.
- Regulations of Health Supplies (Reglamento de Insumos para la Salud) addresses specific regulatory requirements for medical devices.
COFEPRIS also develops its own standards and regulations, called NOMs, which is abbreviated from Norma Oficial Mexicana. NOMs exist for a range of activities concerning medical devices, such as NOM-241-SSA1-2021, which addresses COFEPRIS requirements for Good Manufacturing Practices (GMP).
COFEPRIS Mexico medical device regulatory process
There are two registration paths: the standard path (country of origin certification) and the equivalent path (reference countries are the US, Canada, and Japan).
Standard Route
This route involves submitting a complete registration dossier to COFEPRIS. The dossier must include comprehensive technical documentation, clinical evidence, labeling information, and other required documents. COFEPRIS conducts a thorough review of the submitted dossier, which can take a considerable amount of time due to the complexity and volume of submissions.
Equivalency Route
The Equivalency Route allows manufacturers to leverage approvals obtained in recognized regulatory jurisdictions such as the United States (FDA), Canada (Health Canada), or Japan (PMDA). The Equivalency Route is typically faster than the standard route since it relies on existing approvals and requires less extensive documentation.
Class I, II, and III devices must also provide proof of a quality management system (QMS). This can include a certificate of Good Manufacturing Practices issued by the health authority in the device’s country of origin or an equivalent document, such as an ISO 13485 certificate or CE Mark certificate.
Helpful resources for COFEPRIS medical device registration
As you begin planning to market your device in Mexico, here are some resources that will be useful along the way:
- COFEPRIS: Mexico’s medical device and IVD regulatory authority.
- General Health Law: Mexico’s medical device and pharmaceutical regulatory framework.
- Regulation of Health Supplies: Regulation specifying regulatory requirements for medical devices; revised in 2021.
- NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices: Standard that defines design, development, manufacture, storage, and distribution requirements for medical devices in Mexico.
Frequently
Asked Questions
How much does it cost to register a medical device in Mexico?
The general cost to enter the Mexican market depends on your specific situation and device (route, classification, etc.). However, a general cost range would be between $5,000 and $10,000 USD. This does not include any additional testing and certification which might apply to a specific classification or device.
How long does it take to obtain COFEPRIS medical device registration?
COFEPRIS medical device review timelines vary by classification and regulatory route:
- For any application, the official time for a resolution is 30 working days (according to COFEPRIS guidelines).
- For an application in the standard route, the real time is approximately 10-18 months.
- For an application in the equivalency route, the real time is approximately 6-12 months.
- If any application receives a deficiency letter a time of 6-8 months must be added to get the final resolution.
The best case scenario is six months for a device submitted using the equivalence route with no deficiency letter. The worst case scenario would be 26 months (about 2 years) for a device using the standard route with a deficiency letter.
How long does my Mexico medical device registration remain valid?
Market authorizations for medical devices are valid for five years. To renew, you must submit your renewal documentation 150 days before the expiration date. Note that there are two types of renewals: first-time renewals and second or posterior renewals. Documentation requirements for first-time renewals are more comprehensive than for subsequent renewals, including a GMP certification and technovigilance report. All renewals carry a fee.
