About CAPIBAM
We are a company with more than10 years of experience in consulting services an medial device regulation in Mexico. We offer our services with passion and integrity, we give support manufacturers, distributors, trades and importers of medical devices, we create strategies in compliance with current regulation offering a professional support.
We respond to this challenge working day by day to strengthen our portfolio of services, working with accurate, fast and open communication, always favoring the teamwork consultant-organization trough clear objectives, derived from the customer's needs to make appropriate decisions for proper health care regulation.
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.
