- General Health Law (Ley General de Salud -LGS), provides the general frame of regulation and describes all that is considered a medical device.
- Regulations for health supplies (Pharmaceuticals and Medical devices) (Reglamento de Insumos para la Salud – RIS). Provides more specific frame for regulation of health supplies, requirements and timings.
- FEUM (Mexican Pharmacopeia)– Supplement for warehouses. Describes in detail the quality system required for Health supplies’ warehouses, and the requirements for construction and operation of the establishment.
- Applicable mandatory norms:
- NOM-241 SSA-2012: GMPs for medical devices (in revision): There is a specific norm that applies for Medical devices manufacturing. However, it is equivalent to ISO 13485 and with the compliance certificate you can proceed to registration.
- NOM-137 SSA1-2008: Labeling for medical devices. It is mandatory that all medical devices are labeled in Spanish with specific information about the importing/distributing company and the registration number to be released from customs for sale in Mexico.
- NOM- 240 SSA-2013: Techno vigilance (in revision). Post marketing surveillance for safety is mandatory in Mexico and will be requested for renewal of the registration.
- Biocompatibility testing regulation, is published in Spanish, but corresponds to the international.
Unfortunately, our regulation is only published in Spanish. However, if you have any doubt, we will be happy to answer any inquiry, contact us.
We will be discussing in the future updates on the regulation, to be up to date, please subscribe to our newsletter, link on the footer.
