Medical Device Registration in Mexico


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Medical Device Registration in Mexico

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Medical Device Registration in Mexico

  1. 1. Sanitary Registration for Medical Devices In Mexico
  2. 2. What is aSanitary Registry? Under the terms of the General Health Law in Mexico (Article 376), Regulatory approval is a Sanitary Authorization, with which must drugs, narcotics, psychotropic substances, or products that contain them; medical devices, prosthetics, orthotics, functional aids, diagnostic agents, use dental supplies, surgical supplies, hygiene and healing products, pesticides and plant nutrients; must have.
  3. 3. What is Medical Device? A medical device is an instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, or other similar or related article, including components and accessories; used to prevent, diagnose or replace the operation of any part of the body.
  4. 4. REGULATORYAPPROVALFOR MEDICALDEVICES In Mexico, any medical device intending to be manufactured, distributed, sold or used in the country requires a Health Registry. The Health Registration applicant must demonstrate through documented evidence that the product to be registered is safe, effective and quality.
  5. 5. From 2005 the validity of the Sanitary Registry is 5 years and can be renewed as long as they comply with the provisions established by the Ministry of Health. REGULATORYAPPROVALFOR MEDICALDEVICES
  6. 6. WhogivestheSanitaryAuthorizationin Mexico? COFEPRIS (FEDERAL COMMISSION FOR PROTECTION AGAINST HEALTH RISKS) is the institution responsible for granting Health Records in Mexico.
  7. 7. ClassificationofMedicalDevicesaccording tohealthrisk: For registration purposes the Ministry of Health classifies medical devices according to the health risk involved in their use:  Class I. Are known in medical practice. Its safety and efficacy are proven. Not usually enter the body.  Class II. Are known in medical practice.They may have variations in the material they are made or concentration. Generally introduced into the body, but remaining in less than 30 days.  Class III.Those which are recently accepted in medical practice. Are introduced to the body and stay in for more than 30 days.
  8. 8. ¿Who is ISA HEALTH?
  9. 9. ISA HEALTH is a legal company incorporated in Mexico. We are a team of professionals exclusively working to handle Regulatory Affairs business in United States, Mexico, Colombia, Brazil and Costa Rica for manufacturers and dealers of Health regulated products like: Medical Devices, Medicines, Chemicals, Fertilizers, Pesticides, Food, Dietary Supplements, between others.
  10. 10. ¿ Need to register your medical devices in Mexico? We can help you We have extensive experience in the process of Registration of products with the health authorities. We also offer advice on regulatory compliance based on the Mexican legislation and regulations. We have four offices located in ArlingtonTennessee USA, Colombia Bogotá, Monterrey N.L. México and México D.F.
  11. 11. Among other services we advise and handle:  Sanitary Registration,  Good Manufacturing Practice Certificates, Free Sale Certificates,  Importation Permits,  Advertise Permissions with COFEPRIS,  Licenses Renewals, between others.
  12. 12. Contact us, we will be glad to assist you.
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