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.
Technical Classification of Medical Devices
In accordance with the health risk criteria established by the Health Authority in Mexico, the categorization of medical devices is determined under the following control standards:
Class I
Those supplies known in medical practice and whose safety and efficacy are proven and are generally not introduced into the body.
Class II
Those supplies known in medical practice and which may have variations in the material with which they are made or in their concentration, and are generally introduced into the body remaining for less than thirty days.
Class III
Those supplies that are new or recently accepted in medical practice, or that are introduced into the body and remain in it 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.
Leadership and Competence in Regulatory Management.
Capibam's track record is built on its ability to anticipate regulatory challenges in the healthcare sector. Our approach is based on transforming regulatory complexity into a strategic advantage, safeguarding our clients' operations through unwavering technical rigor and a long-term institutional vision.