GOOD MANUFACTURING PRACTICE AND TECHNOVIGILANCE
In Biomédica Mexicana we have a solid team that is constantly working to maintain the compliance with health regulations applicable to our industry, as the NOM 241-SSA1-2012 concerning to Good Manufacturing Practices for Medical Devices and NOM-240-SSA1-2012 for Technovigilance.
They are a set of interrelated guidelines to ensure that BIOMED´S products maintain identity, purity, and safety activities required for use. In México, the compliance with this regulation is reviewed by the heatlh authority COFEPRIS.
The Technovigilance is a responsibility of medical device manufacturers, their dealers and health authorities. This responsibility can gather information about adverse events and quality failures related to medical devices, in order to implement immediate corrective actions to eradicate them. The main objective is to look after the welfare of patients requiring the use of the medical device.
Biomédica Mexicana has developed a program that allows us Technovigilance effectively receive all reports from the market we serve. These reports give us the opportunity to address the adverse event immediately and make the appropriate correction..
If you had an adverse event of know of the existence of anyone relationated wit BIOMED´s brand, please report it to the pone +52 (55) 5581 5919 ext. 108 or to any of the following email addresses:
Within the report it is important to send us the following information:
- Name and device´s code that presented the incident.
- Product batch and / or serial number.
- Name and age of the patient.
- Institution in which the incident occurred.
- Description of the incident.
- Result of the incident (caused effects).
- Name and contact details of who reported the incident.
