We have talked about the documentary requirements for the application for the Sanitary Authorization (Marketing Authorization) of a Medical Device (MD), however, it is important that you also know that in order to be the Holder of the Sanitary Authorization, prior to the application for the Sanitary Authorization, you must comply with the following requirements in accordance with Article 181 of the Health Supplies Regulation (RIS) and the Pharmacopoeia of the United Mexican States (FEUM) Supplement for MDs:
Article 181 of the RIS states the following:
To be a holder of the Sanitary Authorization of the Supplies referred to in Chapter IX, of the Second Title of this Regulation, it is required to have a Notice of Operation of factory or production laboratory, warehouse of deposit or distribution or conditioning established in the national territory.
And to which Chapter IX of the Second Title of these Regulations refers: this section is exclusively focused on medical equipment, prosthesis, orthesis, functional aids, diagnostic agents, dental supplies, surgical and healing material, hygienic products and other devices for medical use, generally known as Medical Devices.
Therefore, in accordance with the provisions of Article 181 of the RIS, in order to be the holder of the Sanitary Authorization of a MD, it is required to have a Notice of Operation with the following particularities according to the type of establishment you have:
- If you are a Factory or Production Laboratory established in Mexico you require:
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- Notice of Operation of Medical Devices or Herbal Remedies Factory.
- If you are a warehouse or distribution or conditioning warehouse established in Mexico you require:
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- Notice of Operation of Warehouse and/or Distribution of Medical Devices or Herbal Remedies or Uncontrolled Medicine or Raw Materials for Uncontrolled Medicine).
Additionally, the FEUM supplement indicates that in order to become a Holder it is required to:
- Submit the application in the official format, adding the corresponding fee payment according to the classification based on the sanitary risk of the product according to the Federal Law of Payment of Fees.
- Submit a copy of the Notice of Sanitary Responsible.
- In the case of MD that use radiation sources, in addition to the above, submit a copy of the corresponding license issued by the Ministry of Energy (National Commission for Nuclear Safety and Safeguards).
- As well as the file with the scientific and technical information describing the characteristics of the MD and demonstrating the safety and efficacy of the same, as well as the corresponding legal documentation (Art. 179 and 180 of the RIS for details on this topic visit our blog https://bit.ly/3ENEozL).
So if you are considering to become a holder of the Sanitary Authorization of a MD, remember that you must first register a Notice of Operation established in the national territory before the COFEPRIS and if you need help in carrying out this procedure, contact us and we can help you.
Do not miss our next blog topic, where we will be sharing information to continue learning about relevant topics on Health Regulation.
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