ANCE provides a number of services for the health sector. We can improve your procedures and offer support from qualified professionals certified by the health authorities.
ANCE’s certificates ensure a better chance to remain competitive in an increasingly demanding labor market.
• Third party authorized by the Federal Commission for Protection Against Sanitary Risks (Comision Federal para la Proteccion contra Riesgos Sanitarios, COFEPRIS) to verify Dossiers of Class I, II, and III Medical Devices from national and foreign companies conducting health product import, distribution, or manufacturing interested in registering their products in Mexico.
• Third party authorized by COFEPRIS to evaluate standard NOM-251-SSA1- 2009, Hygienic practices for food, beverage, or food supplement processing.
We test and certify Electromedical equipment, including humidifiers, vital sign monitors, ventilators, or anesthesia machines. ANCE is certified to conduct comparison tests based on a wide variety of compliance and operation criteria in accordance to IEC 60601-1-2 international standards, the industry, and the government (COFEPRIS), giving our clients the chance to commercialize their products in both national and global markets. Our services include:
• Electrical safety tests (NOM-001-SCFI, NOM-016-SCFI, and NOM-019-SCFI)
• IEC 60601-1-2 tests for compliance with COFEPRIS requirements
• FDA tests
• EMC tests
• Pre-certification tests
+52 (55) 5747 – 4550