About CAPIBAM®
CAPIBAM® specializes in the Regulation of Medical Devices before COFEPRIS (Ministry of Health in Mexico).
Our services include:
1. Preparation of files for obtaining:
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Official Registers of Medical Devices,
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Amendments to the conditions of the Official Registry of Medical Devices,
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Extensions of Official Registration of Medical Devices.
2. Technical and Regulatory Consulting.
3. Medical Surveillance (Technological Surveillance).
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Local representation (Holder of the Medical Device Registry in Mexico): CAPIBAM® offers local representation services or Official Registry Holder services before COFEPRIS for medical device companies seeking to sell their products in Mexico.
We manage the administration of the Official Registers, and your company has control over appointing and/or changing distributors at any time.
CLASSIFICATION OF MEDICAL DEVICES
CLASS I
Those inputs known in medical practice and whose safety and effectiveness are proven and, generally, are not introduced into the body.
CLASS II
Those inputs known in medical practice and that may have variations in the material with which they are made or in their concentration, and generally, they are introduced into the body remaining less than thirty days.
CLASS III
Those new or recently accepted inputs in medical practice, or those that are introduced into the body and remain there for more than thirty days.
CATEGORIES OF MEDICAL DEVICES
Medical Equipment : Devices, accessories and instruments for specific use, intended for medical or surgical care or procedures for examination, diagnosis, treatment and rehabilitation of patients, as well as those for carrying out biomedical research activities.
Prosthesis, Orthosis, functional aids : Those devices intended to replace or complement a function, an organ, or a tissue of the human body.
Diagnostic Agents: All supplies including antigens, antibodies, calibrators, verifiers, reagents, reagent kits, culture and contrast media, and any other similar items that may be used as an aid to other clinical or paraclinical procedures.
Dental supplies: All substances or materials used for dental health care.
Surgical and Healing Materials: Devices or materials that, with or without the addition of antiseptics or germicides, are used in surgical practice or in the treatment of continuity solutions, skin lesions or their appendages.
Hygienic Products: Materials and substances applied to the surface of the skin or body cavities that have a pharmacological or preventive action.
