In order to market a medical device in Mexico, it is necessary to have a sanitary authorization for the product, the name of such authorization is called SANITARY REGISTRATION.
MEDICAL DEVICE
Substance or mixture of substances, material, apparatus or instrument used alone or in combination in the diagnosis, monitoring, prevention of diseases, auxiliary in the treatment of disease or disability; as well as those used in the replacement, correction, restoration or modification of human anatomy and physiological processes.
LEGAL BASIS:
Medications, narcotics, psychotropic substances and products that contain them require health registration; medical equipment, prostheses, orthotics, functional aids, diagnostic agents, dental supplies, surgical and healing materials and hygienic products , the latter in the terms of section VI of article 262 of this Law, as well as pesticides, nutrients vegetables and toxic or dangerous substances.
CLASSIFICATION OF MEDICAL DEVICES:
Pasos para comercializar
tu dispositivo médico
01
Alta de establecimiento
mediante aviso de funcionamiento
02
Obtención de Certificado de buenas prácticas de fabricación emitido por COFEPRIS (Productos nacionales)
03
Autorización de la venta del producto medicante Registro sanitario
Basado en clasificación según nivel de riesgo.
04
Autorización de actividades
* Importación (Permiso sanitario de importación)
*Publicidad (Aviso o permiso)
Es un trámite muy rápido y sencillo que se realiza en plataforma electrónica DIGIPRIS.
Encontrarás el lista completo de los requisitos que conforman el dossier.
Una vez que se obtenga el registro sanitario puedes solicitar autorización para publicitar tus productos.
Clasificación de dispositivos médicos en México
ACCORDING TO THE PURPOSE OF USE:
I. Medical equipment : devices, accessories and instruments for specific use, intended for medical, surgical care or procedures for exploration, diagnosis, treatment and rehabilitation of patients, as well as those for carrying out biomedical research activities
II. Prosthetics, orthotics and functional aids: those devices intended to replace or complement a function, an organ or a tissue of the human body
III. Diagnostic agents : All supplies including antigens, antibodies, calibrators, verifiers, reagents, reagent kits, culture and contrast media and any other similar that can be used as an aid to other clinical or paraclinical procedures.
IV. Dental supplies: all substances or materials used for dental health care
V. Surgical and healing materials: Devices or materials that, whether or not antiseptics or germicides are added, are used in surgical practice or in the treatment of continuity solutions, skin lesions or its attachments.
SAW. Hygienic products: The materials and substances that are applied to the surface of the skin or body cavities and that have pharmacological or preventive action.
ACCORDING TO LEVEL OF RISK:
Class I : Those inputs known in medical practice and that their safety and efficacy are proven
Class II : Those inputs known in medical practice and that they may have variations in the material with which they are made or in your concentration.
Class III : Those new or recently accepted inputs in the medical practice.
I. I dont know they introduce the organism
II. They enter the body staying less than 30 days
III. They enter the body and they remain in it, for more than 30 days.
PROCEDURES WITH WHICH REGULATE CAN SUPPORT YOU
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Medical device, medicine or cosmetic?
Are you confused with your product?
Not sure if your product requires sanitary registration?
Not sure if your product is low risk?
You do not know what level of risk is your medical device?
Medical devices
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Your product does not require sanitary registration, but do you require COFEPRIS to issue you a letter stating that your product does not require sanitary authorization because they are asking for it at customs?
Medical devices
You have already assembled your dossier, but do you want us to review the format and content prior to submitting it to COFEPRIS?
Our experts have worked in COFEPRIS and authorized third parties, so you will have an effective validation.
IN ADDITION, WE PREPARE THE DOSSIER FOR THE SUBMISSION OF APPLICATION FOR:
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Class I Low Risk
Class I
Class II
Class III
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Extension of validity
Administrative
Cession of rights
Change in name of holder
Distinctive denomination
Distributor