You are already a Medical Device Sanitary Authorization Holder, what's next?
Now that you are already a Medical Device Sanitary Authorization Holder or you are in the process of obtaining the title and you have wondered if you are prepared for the activities, responsibilities and obligations that you must comply with according to the current Health Regulation?
Don't be overwhelmed, you have arrived to GMVR's Sanitary Regulation blog, here we will help you to note these doubts, together we will review what is indicated in the current Sanitary Regulations, in order to give you an overview of what you are obliged to comply with being a Holder of a Sanitary Authorization of a Medical Device.
In our issue https://bit.ly/3NPm3px we reviewed that the Notice of Operation is the first Requirement to be a Holder of a Sanitary Authorization, with this Notice of Operation before COFEPRIS the Holders are obliged to comply with all the dispositions established in the General Law of Health and in the Health Supplies Regulation, as well as in other applicable regulations (Mexican Official Standards, Pharmacopoeia of the United Mexican States) in order to demonstrate that the Medical Devices have quality, safety, efficacy, purity or stability, so here are the main activities, responsibilities and obligations of a Sanitary Authorization Holder:
- Maintain in force the Certificate of Good Manufacturing Practices (CGMP) of MD.
Remember that if you are a holder-manufacturer you must comply with what is defined in NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices and if you are a Holder-importer you must make sure that your manufacturer keeps its CGMP in force.
- To have the Supplement to the Pharmacopoeia of the United Mexican States (FEUM) for Medical Devices.
If you are an owner-manufacturer, you must have this Supplement, which defines and establishes the specifications that medical devices must meet in order to have the optimum quality and performance level, as well as the methods of analysis for their verification.
- To have and comply with all the guidelines indicated in the Supplement for establishments dedicated to the sale and supply of medicines and other health supplies of the FEUM (Manufacturer-Holder, Holder-Importer).
In this Supplement you will find the support to perform the various tasks ranging from the opening of an establishment, handling, distribution, storage, sale and supply of medicines and other health supplies, you will also find the documentary requirements, infrastructure and operation of your establishment.
- Have a Technovigilance Committee and carry out Technovigilance activities.
The law requires informing the Health Authority about the Adverse Events of Medical Devices that occur during the commercialization or use of these, those reported by health professionals, those published in the scientific literature and those reported by international health organizations, for this we recommend you to consult the following Standard: Norma Oficial Mexicana NOM-240-SSA1-2012, Instalación y operación de la tecnovigilancia.
- Inform the Health Authority of any change related to the Healthcare Provider.
When the person in charge of health ceases to render services in the establishment, notice must be given to the Ministry of Health in the format issued for such purpose, within ten days after the date of the termination and of the designation of the new person in charge of health within thirty days after the date on which the previous person in charge of health ceased to render services.
Likewise, to notify to the Health Authority in case of temporary absence greater than thirty calendar days of the Healthcare Provider the name of the person who will represent the Healthcare Provider.
- To answer to the Health Authority for any requirement of safety and efficacy of the Medical Device.
Respond within fifteen days from the date of notification to the Health Authority for any safety and efficacy requirement that the Health Authority determines due to evidence that a Medical Device lacks safety, efficacy, purity or stability.
- Communicate to the Health Authority in the event of temporary or permanent closure of the establishment.
Communicate to the Health Authority at least thirty days prior to the date on which it intends to close its establishment, except in the case of an act of God or force majeure.
- To have a person in charge to attend verification visits.
Is responsible for ensuring that, at all times, within the establishment's hours of operation, there are people who can inform the health authority about the operation of the establishment, in case of a verification visit).
- Comply with NOM-137-SSA1-2008. Medical Device Labeling
Express in the labeling of the products the alphanumeric code and the acronym SSA assigned by the Health Authority, as established in the corresponding Standard.
- Communicate to the Health Authority, in case a Maquila is needed.
To give written notice to the Health Authority when the product of which it is holder is manufactured all or in part, by any manufacturer. Guarantee that the maquila product is manufactured under the same conditions in which the Sanitary Registration was granted, for which we recommend you to consult the following Norm: Mexican Official Standard NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices.
- Notify COFEPRIS upon confirmation that a medical device was falsified for its withdrawal from the market.
- Submit the Renewal of the Sanitary Registration in due time and form.
- Submit the Variations to the Sanitary Registration in case they are required.
- Submit the Revocation of the Sanitary Registration in case it is so decided.
As we can see, the activities, responsibilities and obligations of a Sanitary Authorization Holder are wide and varied, however, all of them are aimed at guaranteeing that the Medical Devices are safe, effective and of high quality for the Mexican population.
If you have any questions about this topic or about the application of any procedure before COFEPRIS contact us at (+52) 55 6167 7092, we can help you with your project.
Give us your opinion about this blog and share with us if there is any topic in Health Regulation that you would like us to review in the next issue.
Comments powered by CComment