Sanitary Registry of Medical Device

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:

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.

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.

PROCEDURES WITH WHICH REGULATE CAN SUPPORT YOU

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CLASSIFICATION

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?

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INQUIRIES

Medical devices

  • 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?

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DOSSIER VALIDATION

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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New records
  • Class I Low Risk

  • Class I

  • Class II

  • Class III

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Extensions
  • Extension of validity

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Modifications

Administrative  

  • Cession of rights

  • Change in name of holder

  • Distinctive denomination

  • Distributor

DO YOU HAVE SUPPORT PRODUCTS FOR THE COVID 19 SITUATION?

Did you know that so you can market medical devices such as protective masks, face masks, oximeters, thermometers, etc. It is required to have a sanitary authorization (Registry) from the Sanitary authority (COFEPRIS).

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